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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsEar, Nose, and Throat Devices Panel

Meeting Date: 4/30/15-5/1/15

Meeting Details:

On April 30, 2015, the committee will discuss and make recommendations regarding the classification of Hearing Protectors, Circumaural Hearing Protectors, Middle Ear Inflation Devices, Tactile Hearing Aid Devices, and Vestibular Analysis Apparatuses. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Hearing Protectors are currently regulated under the heading, “Protector, Hearing (Insert),” Product Code EWD, as unclassified under the 510(k) premarket notification authority. Circumaural Hearing Protectors are currently regulated under the heading, “Protector, Hearing (Circumaural),” Product Code EWE, as unclassified under the 510(k) premarket notification authority. Middle Ear Inflation Devices are currently regulated under the heading, “Device, Inflation, Middle Ear,” Product Code MJV, as unclassified under the 510k) premarket notification authority. Tactile Hearing Aid Devices are currently regulated under the heading, “Hearing Aid, Tactile,” Product Code LRA, as unclassified under the 510(k) premarket notification authority. Vestibular Analysis Apparatuses are currently regulated under the heading, “Apparatus, Vestibular Analysis,” Product Code LXV, as unclassified under the 510(k) premarket notification authority. FDA is seeking committee input on the risks, safety and effectiveness and the regulatory classification of Hearing Protectors, Circumaural Hearing Protectors, Middle Ear Inflation Devices, Tactile Hearing Aid Devices, and Vestibular Analysis Apparatuses. On May 1, 2015 the committee will discuss key issues related to a potential pre- to post-market shift in clinical data requirements for modifications to cochlear implants in pediatric patients. These issues are categorized into three broad areas for discussion: 1. Cochlear implant changes (e.g. sound processing features, patient characteristics) that may be suitable for this pre- to post-market shift in clinical data requirements. 2. Appropriate premarket clinical data requirements to support pre- to post-market shift (e.g. leveraging clinical data from adults and/or older children.) 3. Clinical study design considerations (e.g. study endpoints and test metrics, subject characteristics) for post market studies to confirm safety and effectiveness and inform future labeling.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsEar, Nose and Throat Devices Panel

Meeting Date: 11/8/13-11/8/13

Meeting Details:

On November 8, 2013, the committee will discuss, make recommendations, and vote on information regarding the premarket approval (PMA) application for the Nucleus® Hybrid™ L24 Implant System sponsored by Cochlear Americas. The proposed Indication for Use for the Nucleus® Hybrid™ L24 Implant System (as stated in the PMA) is as follows: The Nucleus® Hybrid™ L24 Implant System is intended for patients aged 18 years and older who have residual low-frequency hearing sensitivity and bilateral severe to profound high frequency sensorineural hearing loss, and who obtain limited benefit from bilateral hearing aids.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsEar, Nose, and Throat Devices Panel

Meeting Date: 12/18/09-12/18/09

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by Envoy Medical Corporation, for the Esteem Totally Implantable Hearing System. The ESTEEM is a totally implantable hearing device that is implanted in the middle ear to help hearing in patients suffering from mild to severe hearing loss that is sensorineural in origin. The Esteem System consists of three implantable components (Sound Processor, Sensor, and Driver), two external programmers (Esteem Programmer and Personal Programmer), an external Intraoperative System Analyzer (ISA) and accessories. The intended use of the ESTEEM is to alleviate hearing loss in adults by replicating the ossicular chain and providing additional gain. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsEar, Nose, and Throat Devices Panel

Meeting Date: 10/6/04-10/6/04

Meeting Details:

The committee will discuss general issues surrounding the prescription use versus over the counter (OTC) use of devices intended to treat snoring or mild to severe obstructive sleep apnea (OSA). The discussion will include the role of the medical/dental provider in the diagnosis, treatment and follow-up of snoring and OSA; the ability of the patient to self diagnose and treat OSA; the types of clinical data that would be needed to support an OTC intended use; and the components of adequate device labelling. The discussion will not include continuous positive airway pressure (CPAP) devices and surgical treatments for OSA.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsEar, Nose, and Throat Devices Panel

Meeting Date: 8/16/02-8/16/02

Meeting Details:

The committee will discuss and make recommendations on a draft guidance entitled “Implantable Middle Ear Hearing Device; Draft Guidance for Industry and FDA.” The topics for discussion will include the appropriate study population, objective measurement techniques for comparison of acoustic hearing aids and middle ear hearing devices, and subjective questionnaire development for determining postoperative effectiveness and quality of life outcome measures.

 

       
Location: Gaithersburg, MD Related News Links: Not Available
Time: 12:30PM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsEar, Nose and Throat Devices Panel

Meeting Date: 7/20/00-7/21/00

Meeting Details:

On July 20, 2000, the committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for a direct-drive implantable middle ear hearing device intended to provide a useful level of sound perception via mechanical stimulation of the ossicles. On July 21, 2000, the committee will discuss, make recommendations and vote on a PMA for an implant intended to restore useful hearing to individuals with Neurofibromatosis Type II who have become deaf as a result of surgery to remove bilateral auditory nerve tumors.

 

       
Location: Gaithersburg Holiday Inn Gaithersburg, MD. Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsThe Ear, Nose and Throat Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 6/18/99-6/18/99

Meeting Details:

The committee will discuss generic issues relating to the safety and efficacy of middle ear amplification devices. *** Call for Satellite, Videoconferencing and Webcasting ***

 

       
Location: Corporate Bldg. Conference room 020B 9200 Corpor Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsArthritis AdComm

Meeting Date: 2/9/16-2/9/16

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Meeting Details:

The committee will discuss biologics license application (BLA) 125544, for CT-P13, a proposed biosimilar to Janssen Biotech Inc.'s REMICADE (infliximab), submitted by Celltrion, Inc. The proposed indications (uses) for this product are: (1) Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy; (2) reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn's disease; (3) reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy; (4) reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy; (5) reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy;1 (6) in combination with methotrexate, reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis; (7) reducing signs and symptoms in patients with active ankylosing spondylitis; (8) reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis; and (9) treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 7:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 2/18/16-2/18/16

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Meeting Details:

The Committee will discuss and make recommendations on clinical trial, postapproval study design, and physician training requirements for leadless cardiac pacemaker device technology. Specifically, the Committee will be asked to make recommendations on the acceptability of adverse event rates in acute and chronic timeframes as well as indications for use for this device type, given availability of other technologies with different adverse event profiles; required training and acceptability of observed learning curves for the new device type and necessary elements for postapproval study collection.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 2/19/16-2/19/16

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Meeting Details:

The Committee will discuss the premarket application for the DIAM Spinal Stabilization System. The DIAM Spinal Stabilization System is indicated for skeletally mature patients that have low back pain (with or without radicular pain) with current episode lasting less than 1 year in duration secondary to moderate lumbar degenerative disc disease (DDD) at a single level from L2-L5. DDD is confirmed radiographically with one or more of the following factors: (1) Patients must have greater than 2 millimeters of decreased disc height compared to the adjacent level; (2) scarring/thickening of the ligamentum flavum, annulus fibrosis, or facet joint capsule; or (3) herniated nucleus pulposus. The DIAM device is implanted via a minimally invasive posterior approach. Amended: The Committee will discuss, make recommendations, and vote on information regarding the premarket application (PMA) for the DIAM Spinal Stabilization System, sponsored by Medtronic Sofamor Danek USA. The DIAM Spinal Stabilization System is indicated for skeletally mature patients that have moderate low back pain (with or without radicular pain) with current episode lasting less than 1 year in duration secondary to lumbar degenerative disc disease (DDD) at a single symptomatic level from L2-L5. DDD is confirmed radiologically with one or more of the following factors: (1) Patients must have greater than 2 mm of decreased disc height compared to the adjacent level; (2) scarring/thickening of the ligamentum flavum, annulus fibrosis, or facet joint capsule; or (3) herniated nucleus pulposus. The DIAM device is implanted via a minimally invasive posterior approach.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

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

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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: [cir] 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). [cir] 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. [cir] 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. [cir] 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). [cir] 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. [cir] 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 [[Page 940]] 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. [cir] IFU/IU: May be used to perform therapeutic plasma exchange. [cir] 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. [cir] 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. [cir] 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 OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 3/4/16-3/4/16

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Meeting Details:

On March 4, 2016, the committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2016-2017 influenza season.

 

       
Location: TBD Related News Links: Not Available
Time: 8:30AM-3:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 3/15/16-3/16/16

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Meeting Details:

On March 15, 2016, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System sponsored by Abbott Vascular. The Absorb GT1 BVS System is a temporary scaffold that will fully resorb over time and is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo native coronary artery lesions (length = 24 millimeters (mm)) with a reference vessel diameter of = 2.5 mm and = 3.75 mm. On March 16, 2016, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the AngelMed Guardian System sponsored by Angel Medical Systems, Inc. The AngelMed Guardian System is an implantable cardiac monitor intended to alert patients to ST segment shifts indicating coronary ischemia. The AngelMed Guardian System is intended for use in patients with prior acute coronary syndrome events, and at risk for recurrent events, to ST segment changes indicating cardiac ischemia.

 

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

Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs Advisory Committee

Meeting Date: 2/3/16-2/3/16

Meeting Details:

During the morning session, the committee will discuss cognitive dysfunction in major depressive disorder (MDD). This is an evolving concept and experts in the field have not yet reached consensus as to whether cognitive dysfunction in MDD is a distinct entity. The committee will consider the clinical presentation of cognitive dysfunction in MDD, as well as methods for assessing this condition. During the afternoon session, the committee will discuss new drug application 204447/supplemental new drug application 006, for the effectiveness of vortioxetine for the treatment of cognitive dysfunction in MDD, submitted by Takeda Development Center Americas, Inc.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPOSTPONED: Peripheral and Central Nervous System Drugs AdComm

Meeting Date: 1/22/16-1/22/16

Meeting Details:

The postponement is due to inclement weather forecasted for the Washington, DC area. The committee will discuss new drug application 206488, eteplirsen injection for intravenous infusion, sponsored by Sarepta Therapeutics, Inc., for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsAllergenic Products AdComm

Meeting Date: 1/21/16-1/21/16

Meeting Details:

The committees will discuss safety and effectiveness data, including challenge study endpoints, for licensure of food allergy immunotherapy products, and the clinical development of aeroallergen immunotherapy products for the prevention of respiratory allergic disease.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:30AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs AdComm - PROBUPHINE

Meeting Date: 1/12/16-1/12/16

Meeting Details:

The committee will discuss new drug application (NDA) 204442, PROBUPHINE (buprenorphine hydrochloride and ethylene vinyl acetate) subdermal implant, submitted by Braeburn Pharmaceuticals, Inc., on behalf of Titan Pharmaceuticals for the proposed indication of maintenance treatment of opioid dependence.

 

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

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