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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel of the Medical Devices AdComm

Meeting Date: 5/17/17-5/17/17

Meeting Details:

On May 17, 2017, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the TRANSMEDICS ORGAN CARE SYSTEM (OCS)--Lung System, by TransMedics, Inc. The proposed Indication for Use, as stated in the PMA, is as follows: The TRANSMEDICS ORGAN CARE SYSTEM (OCS) Lung System is a portable organ perfusion, ventilation, and monitoring medical device intended to preserve donor lungs in a near physiologic, ventilated, and perfused state for transplantation.

 

       
Location: Hilton Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 2/25/16-2/26/16

Meeting Details:

On February 25, 2016, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for "TOPAS Treatment for Fecal Incontinence," by ASTORA Women's Health, LLC. The "TOPAS Treatment for Fecal Incontinence" device is a sling device (mesh) to be implanted around the puborectalis muscle (a muscle that contributes towards the maintenance of fecal continence). The proposed Indication for Use (IFU) for the "TOPAS Treatment for Fecal Incontinence" device, as stated in the PMA, is as follows: The "TOPAS Treatment for Fecal Incontinence" is intended to treat women with fecal incontinence (also referred to as accidental bowel leakage) who have failed more conservative therapies. On February 26, 2016, during session I, the committee will discuss and make recommendations regarding the reclassification of urogynecologic surgical mesh instrumentation from class I to class II. The applicable product codes are those related to urogynecologic surgical mesh as follows: • OTN and the associated device classification name, "mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, multi-incision;" • PAG and the associated device classification name, "mesh, surgical, non-synthetic, urogynecologic, for stress urinary incontinence, female, multi-incision;" • PAH and the associated device classification name, "mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, single-incision mini-sling;" • OTO and the associated device classification name, "mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed;" • PAJ and the associated device classification name, "mesh, surgical, non-synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed;" • OTP and the associated device classification name, "mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed" and • PAI and the associated device classification name, "mesh, surgical, non-synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed." Some examples of the means by which these devices perform these functions and their respective IFU/Intended Use (IU) statements are: • Urogynecologic surgical mesh instrumentation is used: ? IFU/IU: To aid in insertion, placement, fixation, or anchoring of surgical mesh for procedures including transvaginal pelvic organ prolapse repair, sacrocolpopexy (transabdominal pelvic organ prolapse repair), treatment of female stress urinary incontinence. Examples of such surgical instrumentation include needle passers and trocars, needle guides, fixation tools, and tissue anchors. The committee, during session II, will discuss and make recommendations regarding the classification of the product code "LKX" and the associated device classification name, "Device, Thermal, Hemorrhoids." The product code LKX represents a category of devices intended to apply controlled cooling and conductive heating to hemorrhoids. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Some examples of the means by which these devices perform these functions and their respective IFU/IU statements are: • Uses an aluminum probe that contains a temperature sensitive element to regulate temperature within 2 degrees (between 37 and 46 degrees centigrade). ? IFU/IU: The apparatus is intended to apply controlled, conductive heating to hemorrhoids. • Uses a heat applicator inserted into the rectum, applicator contains a battery operated heater, and a sensor which provides temperature control/feedback. ? IFU/IU: Intended to provide temporary relief of the symptoms of hemorrhoids through the application of mild heating. • Uses speculum-like plastic container containing liquid to cool hemorrhoidal veins. ? IFU/IU: Treatment of external hemorrhoids by applying cold therapy (cryotherapy) directly to swollen hemorrhoidal veins. The committee, during session III, will discuss and make recommendations regarding the classification of the product code "LRL" and the associated device classification name, "Cushion, Hemorrhoid." The product code LRL represents a category of devices intended to temporarily relieve pain and pressure caused by hemorrhoids. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Some examples of the means by which these devices perform these functions and their respective IFU/IU statements are: • Uses an injection molded polypropylene copolymer plastic seat attached to a toilet seat (the product is adjustable and is available in round and elongated versions). ? IFU/IU: For the temporary relief from the pain and pressure of hemorrhoids. The device is for external use only. • Uses a cushion with an inflatable vinyl exterior and a foam center. An air chamber, when filled, prevents the cushion from compressing the foam. A urethane foam center adds comfort. ? IFU/IU: Intended for the home convalescent patient with perineal discomfort. • Uses a cushion that contains two internal molded structures that conform to the patient's shape. Exerts "slight" pressure on hemorrhoid. IFU/IU not required at the time of clearance. The committee, during session IV, will discuss and make recommendations regarding the classification of the product code "LKN" and the associated device classification name, "Separator, automated, blood cell and plasma, therapeutic." The product code LKN represents a category of centrifuge-type devices intended to separate blood components and perform therapeutic plasma exchange for the management of serious medical conditions in adults and children. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Some examples of the means by which these devices perform these functions and their respective IFU/IU statements are: • Utilizes a continuous flow centrifuge (max speed 3000 revolutions per minute) to separate source blood from a subject into blood components. ? IFU/IU: May be used to perform therapeutic plasma exchange. ? IFU/IU: May be used to perform Red Blood Cell Exchange procedures for the transfusion management of Sickle Cell Disease in adults and children. • Uses continuous flow access to a rotating centrifuge to separate blood components. ? IFU/IU: May be used to harvest cellular components from the blood of certain patients where the attending physician feels the removal of such component may benefit the patient. ? IFU/IU: May be used to remove plasma components and/or fluid selected by the attending physicians.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCANCELLED: Gastroenterology and Urology Devices Panel

Meeting Date: 11/18/15-11/19/15

Meeting Details:

On November 18, 2015, the committee will discuss, make recommendations and vote on information regarding the premarket approval application (PMA) for the TransMedics® Organ Care System™ (OCS)--Heart, by TransMedics, Inc. The proposed Indication for Use for the TransMedics ® Organ Care System™ (OCS)--Heart, as stated in the PMA, is as follows: The TransMedics® Organ Care System™ (OCS)--Heart is a portable, ex vivo organ perfusion system intended to preserve a donor heart in a near-normothermic and beating state from retrieval until the eventual transplantation into a suitable recipient. On November 19, 2015, the committee will discuss and make recommendations regarding the classification of the product code “LKX”, and the associated device classification name, “Device, Thermal, Hemorrhoids”. The product code LKX represents a category of devices intended to apply controlled cooling and conductive heating to hemorrhoids. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Some examples of the means by which these devices perform these functions and their respective Indications for Use (IFU)/Intended Use (IU) statements are as follows: 3 ? Uses an aluminum probe that contains a temperature sensitive element to regulate temperature within 2 degrees (between 37 and 46 degrees centigrade). o IFU/IU: The apparatus is intended to apply controlled, conductive heating to hemorrhoids. ? Uses a heat applicator inserted into the rectum, applicator contains a battery operated heater and a sensor which provides temperature control/feedback. o IFU/IU: Intended to provide temporary relief of the symptoms of hemorrhoids through the application of mild heating. ? Uses speculum like plastic container containing liquid to cool hemorrhoidal veins o IFU/IU: Treatment of external hemorrhoids by applying cold therapy (cryotherapy) directly to swollen hemorrhoidal veins. The committee will also discuss and make recommendations regarding the classification of the product code “LRL”, and the associated device classification name, “Cushion, Hemorrhoid”. The product code LRL represents a category of devices intended to temporarily relieve pain and pressure caused by hemorrhoids. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Some examples of the means by which these devices perform these functions and their respective IFU/IU statements are as follows: ? Uses an injection molded polypropylene copolymer plastic seat attached to a toilet seat (the product is adjustable and is available in round and elongated versions). o IFU/IU: For the temporary relief from the pain and pressure of hemorrhoids. The device is for external use only. 4 ? Uses a cushion with an inflatable vinyl exterior and a foam center. An air chamber, when filled, prevents the cushion from compressing the foam. A urethane foam center adds comfort. o IFU/IU: Intended for the home convalescent patient with perineal discomfort. ? Uses a cushion that contains two internal molded structures that conform to the patient’s shape. Exerts “slight” pressure on hemorrhoid. IFU/IU not provided. The committee will also discuss and make recommendations regarding the classification of the product code “LKN”, and the associated device classification name, “Separator, automated, blood cell and plasma, therapeutic”. The product code LKN represents a category of centrifuge-type devices intended to separate blood components and perform therapeutic plasma exchange for the management of serious medical conditions in adults and children. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Some examples of the means by which these devices perform these functions and their respective IFU/IU statements are as follows: ? Utilizes a continuous flow centrifuge (max speed 3000 rpm) to separate source blood from a subject into blood components. o IFU/IU: May be used to perform therapeutic plasma exchange. o IFU/IU: May be used to perform Red Blood Cell Exchange procedures for the transfusion management of Sickle Cell Disease in adults and children. ? Uses continuous flow access to a rotating centrifuge to separate blood components. 5 o IFU/IU: May be used to harvest cellular components from the blood of certain patients where the attending physician feels the removal of such component may benefit the patient. o IFU/IU: May be used to remove plasma components and/or fluid selected by the attending physicians.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 10/1/14-10/1/14

Meeting Details:

On October 1, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the SONABLATE 450 device sponsored by SonaCare Medical, LLC. The proposed Indication for Use for the SONABLATE 450 device, as stated in the PMA, is as follows: The SONABLATE 450 (SONABLATE) is intended for use in the treatment of localized, clinically recurrent prostate cancer after failure of primary external beam radiation therapy.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 7/30/14-7/31/14

Meeting Details:

On July 30, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the Ablatherm Integrated Imaging device sponsored by EDAP Technomed, Inc. The proposed Indication for Use for the Ablatherm Integrated Imaging device, as stated in the PMA, is as follows: The Ablatherm Integrated Imaging device is intended for the primary treatment of prostate cancer in subjects with low risk, localized prostate cancer. On July 31, 2014, the committee will discuss and make recommendations regarding the classification of Penile Tumescence Monitors, Nephrostomy Catheters, Stimulators for Electrical Sperm Collection, Erectile Dysfunction Devices, and Alloplastic Spermatoceles. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Penile Tumescence Monitors are currently regulated under the heading, ``Monitor, Penile Tumescence,' Product Code LIL, as unclassified under the 510(k) premarket notification authority. Nephrostomy Catheters are currently regulated under the heading, ``Catheter, Nephrostomy,' Product Code LJE, as unclassified under the 510(k) premarket notification authority. Stimulators for Electrical Sperm Collection are currently regulated under the heading, ``Stimulator, Electrical for Sperm Collection,' Product Code LNL, as unclassified under the 510(k) premarket notification authority. Erectile Dysfunction Devices are currently regulated under the heading, ``Device, Erectile Dysfunction,' Product Code LST, as unclassified under the 510(k) premarket notification authority. Alloplastic Spermatoceles are currently regulated under the heading, ``Spermatocele, Alloplastic,' Product Code LQS, as unclassified under the 510(k) premarket notification authority. FDA is seeking committee input on the safety and effectiveness and the regulatory classification of Penile Tumescence Monitors, Nephrostomy Catheters, Stimulators for Electrical Sperm Collection, Erectile Dysfunction Devices, and Alloplastic Spermatoceles.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 6/17/14-6/17/14

Meeting Details:

On June 17, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket application (PMA) for the Maestro® Rechargeable System sponsored by Enteromedics, Inc. The Maestro® Rechargeable System provides VBLOC Therapy. The implantable device is a neuromodulator, which delivers high frequency (5000 Hertz), controllable electrical pulses to the intra-abdominal vagus nerve trunks. The effect of VBLOC therapy is reported to suppress neural signals carried by the vagus nerve trunks, resulting in decreased hunger pangs, decreased digestive enzyme secretion and calorie absorption, and increased satiety. The device consists of implantable electronic device components that deliver VBLOC therapy, and external components that regulate device performance. The proposed indication for use for the Maestro® Rechargeable System, as stated in the PMA, is as follows: The Maestro® Rechargeable System is indicated for use in weight reduction in adult patients with obesity that have a Body Mass Index (BMI) of at least 40 kilograms per square meter (kg/m2), or a BMI of at least 35 kg/m2 with one or more obesity related comorbid conditions, and have failed a more conservative weight reduction alternative.

 

       
Location: FDA Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 3/20/14-3/20/14

Meeting Details:

On March 20, 2014, the committee will discuss, make recommendations, and vote on information regarding the humanitarian device exemption (HDE) application for the XVIVO Perfusion System (XPSTM) sponsored by XVIVO Perfusion, Inc. The proposed Indication for Use for the XVIVO Perfusion System, as stated in the HDE, is as follows: The XPSTM is intended to be used with STEEN Solution for flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donor lungs during which time the function of the lungs can be reassessed for transplantation.

 

       
Location: Holiday Inn, GBurg Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 6/27/13-6/27/13

Meeting Details:

On June 27, 2013, during session I, the committee will discuss and make recommendations regarding the proposed classification of sorbent hemoperfusion systems, one of the remaining preamendments class III devices. The class III sorbent hemoperfusion system is a device intended for the treatment of poisoning, drug overdose, hepatic coma, and metabolic disturbances. It consists of an extracorporeal blood system and a container filled with adsorbent material that removes a wide range of substances, both toxic and normal, from blood flowing through it. The adsorbent materials are usually activated carbon or resins, which may be coated or immobilized to prevent fine particles from entering the patient's blood. The generic type of device may include lines and filters specifically designed to connect the device to the extracorporeal blood system. Sorbent hemoperfusion systems may also include the machine or instrument used to drive and manage blood and fluid flow within the extracorporeal circuit, as well as any accompanying controllers, monitors, or sensors. On April 4, 2013 (78 FR 20268), FDA issued a proposed order which, if made final, would reclassify sorbent hemoperfusion systems labeled for the treatment of poisoning and drug overdose class II subject to premarket notification [510(k)] and special controls, while sorbent hemoperfusion systems labeled for the treatment of hepatic coma and metabolic disturbances would remain class III requiring premarket approval (PMA) applications. The committee’s discussion will involve making recommendations regarding the regulatory classifications noted above. The committee will also discuss whether the proposed special controls are adequate to reasonably ensure the safety and effectiveness of sorbent hemoperfusion devices labeled for the 3 treatment of poisoning and drug overdose. The regulatory history of sorbent hemoperfusion has been discussed as part of a previously published proposed rule (77 FR 9610). During session II on June 27, 2013, the committee will discuss and make recommendations regarding the proposed classification of implanted blood access devices for hemodialysis from class III to class II. The class III implanted blood access devices for hemodialysis include various flexible or rigid tubes, such as catheters, cannulae or hollow needles. Chronic hemodialysis catheters are soft, blunt-tipped plastic catheters that have a subcutaneous “cuff”' for tissue ingrowth. They are placed in a central vein to allow blood access. Chronic hemodialysis catheters serve as conduits for the removal of blood from the patient, delivery to a hemodialysis machine for filtering, and return of filtered blood to the patient. They have no moving parts, consisting, essentially, of flexible tubing terminating in rigid Luer lock connectors for attachment to a dialysis machine. Subcutaneous catheters are totally implanted below the skin surface with no external communication. Arteriovenous shunts and vessel tips are tubing with tapered tips that are inserted into the artery and vein. The tubing is attached to the roughened or etched outer surface of the tip. The tubing is external to the skin and can be accessed with needles. They are similar to subcutaneous catheters. On June 20, 2012 (77 FR 36951), FDA issued a proposed rule which, if made final, would make the class III implanted blood access devices class II subject to premarket notification [510(k)] and special controls. The regulatory history of implanted blood access devices has been discussed as part of the proposed rule (77 FR 36951). The committee’s discussion will involve making recommendations regarding regulatory classification to either reaffirm class III or reclassify these devices into class II and comment on 4 whether special controls are adequate to reasonably ensure the safety and effectiveness of this device.

 

       
Location: Holiday Inn Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 5/10/12-5/11/12

Meeting Details:

On May 10 and 11, 2012, the committee will discuss general issues related to medical devices intended for obese patients. The committee will provide recommendations regarding trial design for clinical studies to evaluate the safety and effectiveness of weight loss devices placed either endoscopically (balloons and suture devices) or laparoscopically (bands, space-occupying devices, etc.) and contrast those to surgery. Additional discussion will include issues pertaining to clinically meaningful weight loss, when the primary endpoint should be measured, length of patient followup, and how much risk is acceptable for a potentially small amount of weight loss.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 1/11/12-1/11/12

Meeting Details:

On January 11, 2012, the committee will discuss, make recommendations, and vote on information related to the premarket approval application, sponsored by Torax Medical, Inc., for the LINX Reflux Management System, a sterile, single use, surgically placed device used to treat the symptoms associated with gastroesophageal reflux disease.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 12/2/10-12/3/10

Meeting Details:

On December 2, 2010, the committee will discuss, make recommendations, and vote on information related to the premarket approval application (PMA) for SOLESTA, sponsored by Oceana Therapeutics, Inc. SOLESTA is indicated for the treatment of fecal incontinence in patients who have failed conservative therapy. On December 3, 2010, the committee will discuss, make recommendations, and vote on information related to the PMA for the LAP-BAND Adjustable Gastric Banding System, sponsored by Allergan. The sponsor is requesting an expanded Indication for Use for their LAP-BAND Adjustable Gastric Banding System to include weight reduction in patients with a Body Mass Index (BMI) of at least 35 kg/m2 or a BMI of at least 30 kg/m2 with one or more comorbid conditions.

 

       
Location: Hilton Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 12/11/09-12/11/09

Meeting Details:

On December 11, 2009, the committee will discuss and make recommendations on the study designs and endpoints of clinical investigations intended to support approval or clearance of devices indicated for the primary treatment of localized prostate cancer.

 

       
Location: Holiday Inn Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 6/10/09-6/10/09

Meeting Details:

The committee will discuss and make recommendations regarding general issues related to the use of ultrafiltration devices in the treatment of extracellular body fluid overload in patients experiencing heart failure. Specifically, the committee will address the use of these devices in patients experiencing heart failure in the following terms: Identifying the most appropriate heart failure patients for whom these treatments should be indicated, determining where these treatments fit within the spectrum of treatment options, and defining what level of clinical evidence is necessary to adequately evaluate and provide labeling for these devices.

 

       
Location: Holiday Inn Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 6/25/08-6/25/08

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by Medical Enterprises, Ltd., for a drug/device combination product designed to prevent recurrence of bladder cancer. Synergo SB-3TS 101.1 Device with Mitomycin C is indicated for use for prophylactic treatment of recurrence in patients following endoscopic removal of Ta-TI and GI-3 superficial transitional cell carcinama of the bladder (STCCB). Ta-T1 refers to the stage of the tumor, which is a measure of how deep the tumor penetrates into the bladder wall, with Ta and T1 being the most superficial stages for raised bladder tumors. (21-3 refers to the tumor grade, which is a measure of how aggressive the tumor is likely fo grow, with G1 being the least aggressive, and G3 the most. Synergo and Mitomycin C treatment is clinically indicated for STCCB patients of intermediate and high risk.

 

       
Location: Hilton Gaithersburg Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 6/8/05-6/8/05

Meeting Details:

The committee will hear a presentation on the FDA Critical Path Initiative and a presentation by the Office of Surveillance and Biometrics in the Center for Devices and Radiological Health outlining their responsibility for the review of postmarket study design. The committee will also discuss and make recommendations regarding general issues related to the premarket requirements for the safe and effective use of hemodialysis equipment labeled for nocturnal hemodialysis therapies.

 

       
Location: HOL - GB Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 1/17/03-1/17/03

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a device for the treatment of gastroesophageal reflux disease.

 

       
Location: H - GB Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 8/17/01-8/17/01

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a device for the treatment of fecal incontinence.

 

       
Location: Corporate Blvd. Rockville, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal and Urology Devices

Meeting Date: 10/19/00-10/19/00

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a device for the treatment of vesicoureteral reflux.

 

       
Location: Rockville, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal and Urology Devices

Meeting Date: 6/19/00-6/19/00

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a device for the treatment of obesity.

 

       
Location: Gaithersburg Hilton Gaithersburg, MD. Related News Links: Not Available
Time: 10:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal and Urology Devices

Meeting Date: 11/19/99-11/19/99

Meeting Details:

The committee will discuss, make recommendations and vote on a premarket approval application (PMA) for an optical device intended to assist in the evaluation of colonic polyps using laser-induced autofluorescence.

 

       
Location: Corporate Bldg. Rockville, MD. Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal and Urology Devices

Meeting Date: 7/29/99-7/29/99

Meeting Details:

The committee will discuss, make recommendations and vote on a premarket approval application (PMA) for a urethral bulking and coaptation device for the treatment of stress urinary incontinence due to intrinsic sphincter insufficiency. The committee will also discuss possible revisions to the Draft Guidance For Preparation of PMA Applications for Testicular Prostheses, March 1993. *** Call for Satellite, Videoconferencing and Webcasting ***

 

       
Location: Corporate Bldg. 9200 Corporate Blvd. Rockville, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal and Urology Devices

Meeting Date: 10/29/98-10/29/98

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval supplement for a new indication for an extracorporeal immunoadsorption device intended for the treatment of rheumatoid arthritis.

 

       
Location: Corporate Building Rockville, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal and Urology Devices

Meeting Date: 7/30/98-7/30/98

Meeting Details:

Agency's Proposed reclassification of external shock wave lithotripters for kidney and uretheral stones.

 

       
Location: Corporate Building Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal and Urology Devices

Meeting Date: 4/30/98-4/30/98

Meeting Details:

The panel will discuss, make recommendations and vote on a premarket approval application for Medstone International's STS Lithotriper P970042 intended to fragment biliray stones. Anthony N. Kalloo, M.D., Gastroenterologist willl present a synopsis of the clinical data. Joseph H. Steinbach, Ph.D., Engineer and Biomathematician will present statistical review of the clinical data. The panel will consider the saftey and effectiveness of this device and the issues for consideration raised by the FDA.

 

       
Location: FDA Corporate Building, Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs

Meeting Date: 2/22/96-2/23/96

Meeting Details:

On February 22, 1996, the committee will discuss new drug application (NDA) 20-580, Cotazyme, and NDA 20- 581, Cotazyme S and Zymase (pancreatic lipase, Organon), indicated for exocrine pancreatic insufficiency. On February 23, 1996, the committee will discuss NDA 20-617, C-14 Urea Breath Test (Trimed Specialties Inc.), for diagnosis of Helicobacter pylori .

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel of the MDAC

Meeting Date: 6/12/18-6/12/18

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Meeting Details:

On June 12, 2018, the committee will discuss, make recommendations, and vote on the premarket approval application sponsored by Cordis, Inc. for the INCRAFT AAA Stent Graft System, which is intended for the endovascular treatment of infra-renal abdominal aortic aneurysms in patients with appropriate anatomy. The INCRAFT device is being evaluated in the INSPIRATION study, a multicenter, prospective, non-randomized investigation. The study met its primary safety and effectiveness endpoints, but results also showed higher than anticipated rates of certain adverse events. The committee discussion will focus on how these events impact the long-term safety and effectiveness, as well as the benefit/risk profile of the device.

 

       
Location: Hilton Gburg Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthesiology and Respiratory Therapy Devices Panel of the MDAC

Meeting Date: 6/14/18-6/14/18

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Meeting Details:

The committee will discuss, make recommendations and vote on information related to PneumRx, Inc.’s premarket approval application for the PNEUMRX ELEVAIR Endobronchial Coil System, which is a first of a kind implantable lung reduction coil for the proposed indication for use in patients with homogeneous and/or heterogeneous severe emphysema to improve quality of life, lung function, and exercise capacity.

 

       
Location: Holiday Inn Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPediatric Oncology Subcommittee of the ODAC

Meeting Date: 6/20/18-6/20/18

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Meeting Details:

The particular matter for this meeting will be review and discussion of a list of molecular targets for which evidence and/or biologic rationale exist to determine their potential relevance to the growth or progression of one or more pediatric cancers and a list of those targets deemed unlikely to be associated with the growth or progression of pediatric tumors. These lists are expected to fulfill the statutory obligation of the Food and Drug Administration Reauthorization Act (FDARA) and provide some guidance to industry in planning for initial Pediatric Study Plan submissions for new drug and/or biologic products in development for cancer in accordance with the amended provisions of the Pediatric Research Equity Act. The committee will review and discuss considerations other than scientific relevance that FDA will include in decision making with respect to the need and timing of pediatric evaluation of specific new drug and biologic products. The committee will discuss possible criteria and mechanisms for the prioritization by sponsors and the clinical investigator community of select targeted new agents for pediatric evaluation especially in the setting of multiple same in class agents. Preliminary discussion will focus on approaches to coordination and collaboration for pediatric clinical investigations of new agents that might be pursued to efficiently accommodate international regulatory requirements and global pediatric product development. The open public hearing sessions are: Topic 1: Target List, Topic 2: FDARA Implementation, and Topic 3: Mechanisms to Assure Efficiency and to Enhance Global Coordination Through International Collaboration.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:30PM    
Materials:
   
       

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsJoint Anesthetic & Analgesic with DSRM AdComm

Meeting Date: 5/22/18-5/22/18

Meeting Details:

The committees will be asked to discuss new drug application (NDA) 209588, for buprenorphine sublingual spray, submitted by INSYS Development Company, Inc., for the treatment of moderate-to-severe acute pain where the use of an opioid analgesic is appropriate. The committees will also be asked to discuss whether this product should be approved.

 

       
Location: FDA Meeting Room - Out Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products Advisory Committee

Meeting Date: 5/17/18-5/17/18

Meeting Details:

On May 17, 2018, under Topic I, the Center for Biologics Evaluation and Research’s (CBER) VRBPAC will meet in open session to discuss approaches for demonstrating effectiveness of group B streptococcus (GBS) vaccines intended for use in pregnant women to protect the newborn infant. Also on May 17, 2018, under Topic II, the committee will meet in open session to hear an overview of the research program in the Laboratory of Respiratory Viral Diseases (LRVD), Division of Viral Products, Office of Vaccines Research and Review, CBER, FDA.On May 17, 2018, under Topic I, the Center for Biologics Evaluation and Research’s (CBER) VRBPAC will meet in open session to discuss approaches for demonstrating effectiveness of group B streptococcus (GBS) vaccines intended for use in pregnant women to protect the newborn infant. Also on May 17, 2018, under Topic II, the committee will meet in open session to hear an overview of the research program in the Laboratory of Respiratory Viral Diseases (LRVD), Division of Viral Products, Office of Vaccines Research and Review, CBER, FDA.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Advisory Committee and the EMDAC

Meeting Date: 5/11/18-5/11/18

Meeting Details:

On Friday, May 11, 2018, the PAC and EMDAC will meet to discuss drug development for the treatment of children with achondroplasia. The following topics should be considered for discussion: evidence required to establish dose-response, study design, study duration, intended population, and endpoints. In the open session, the committee does not intend to discuss any individual research programs.

 

       
Location: Tommy Douglas Conference Center 10000 New Hampshire Avenue Silver Spring, Maryland 20903 Related News Links: Not Available
Time: 12:00PM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 5/10/18-5/10/18

Meeting Details:

The committee will discuss the safety and efficacy of new drug application (NDA) 210645, for volanesoren solution for subcutaneous injection, submitted by Akcea Therapeutics, Inc. The proposed indication is as an adjunct to diet for the treatment of patients with familial chylomicronemia syndrome.

 

       
Location: Tommy Douglas Conference Center Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastro and Pediatric AdComm

Meeting Date: 5/3/18-5/3/18

Meeting Details:

The committees will discuss new drug application (NDA) 209904, for stannsoporfin injection, for intramuscular use, submitted by InfaCare Pharmaceutical Corporation, proposed for the treatment of neonates greater than or equal to 35 weeks of gestational age with indicators of hemolysis who are at risk of developing severe hyperbilirubinemia.

 

       
Location: DoubleTree by Hilton Hotel Bethesda Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs AdComm

Meeting Date: 5/2/18-5/2/18

Meeting Details:

The committee will discuss new drug application (NDA) 210303 for plazomicin, sponsored by Achaogen, Inc., for the proposed indications for the treatment of complicated urinary tract infections and blood stream infections in adults.

 

       
Location: DoubleTree by Hilton Hotel Bethesda Related News Links: Not Available
Time: 8:00AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs AdComm

Meeting Date: 5/1/18-5/1/18

Meeting Details:

The committee will discuss new drug application (NDA) 208627 for tecovirimat, sponsored by SIGA Technologies Inc., for the proposed indication of the treatment of smallpox disease caused by variola virus in adults and pediatric patients. This product was developed under the Animal Rule (21 CFR part 314, subpart I).

 

       
Location: DoubleTree by Hilton Hotel Bethesda Related News Links: Not Available
Time: 10:00AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis and DSRM AdComm

Meeting Date: 4/24/18-4/25/18

Meeting Details:

The committees will be asked to discuss supplemental new drug application (sNDA) 20998 for CELEBREX (celecoxib) capsules submitted by Pfizer, Inc., which includes the results from the PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen Or Naproxen) trial, a cardiovascular outcomes randomized controlled trial that compared celecoxib to ibuprofen and naproxen, and determine whether the findings of the trial change FDA’s current understanding of the safety of these three NSAIDs. In order to interpret some of the PRECISION findings, the committees will also consider the clinical implications of the drug interactions between each of these three NSAIDs and aspirin in patients taking aspirin for secondary prevention of cardiovascular disease.

 

       
Location: FDA Meeting Room - WO Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis AdComm

Meeting Date: 4/23/18-4/23/18

Meeting Details:

The committee will discuss the new drug application (NDA) 207924, for baricitinib tablets, submitted by Eli Lilly and Company, for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. The discussion will include the following: efficacy, safety, including the risk of thromboembolic adverse events, dose selection, and overall risk benefit considerations.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Past Meetings

Below is a listing of all committees. Select a committee to display all meetings available for that committee.

Live Meetings

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