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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 9/24/15-9/24/15

Meeting Details:

On September 24, 2015, the committee will discuss the risks and benefits of Bayer HealthCare’s Essure System for permanent female sterilization. The system, originally approved in November 2002, under P020014, consists of a delivery system and nickel-containing permanent implants. The implants are placed without a skin incision, through the vagina, within each fallopian tube; they elicit tissue ingrowth, which over time results in tubal occlusion.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 7/10/14-7/11/14

Meeting Details:

On July 10 and 11, 2014, the committee will discuss the safety of laparoscopic power morcellator devices as it pertains to their potential to disseminate and upstage a confined, but undetected (occult) uterine malignancy during laparoscopic hysterectomy or myomectomy. FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of these types of devices when used for these procedures, based on available scientific data. The committee will make recommendations regarding the appropriate use, premarket testing, labeling, and other risk mitigations (including the use of containment bags) for these devices. On July 11, 2014, during the afternoon session, the committee will also be asked to discuss the regulatory classification of laparoscopic power morcellator devices when used to cut and extract tissue during gynecologic laparoscopic procedures and to assist FDA in determining the appropriate level of regulatory control necessary for this device type, including discussion of class II (special controls) or reclassification to class III (subject to premarket approval application (PMA)).

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel of the Medical Devices

Meeting Date: 9/8/11-9/9/11

Meeting Details:

On September 8 and 9, 2011, the committee will discuss and make recommendations regarding the safety and effectiveness of transvaginal surgical mesh used for repair of pelvic organ prolapse. FDA is convening this meeting to seek expert opinion on the risks and benefits of these devices in light of adverse events, e.g., vaginal erosion leading to pelvic pain and dyspareunia, and available information on clinical benefit. The committee will be asked to provide scientific and clinical input on the Agency's proposed premarket and postmarket regulatory strategies for these devices, including [[Page 41508]] reclassification into Class III (premarket approval), labeling improvements and postmarket surveillance studies. The committee will also consider surgical mesh used to treat stress urinary incontinence.

 

       
Location: Holiday Inn, Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsCellular, Tissue and Gene Therapies Advisory Committee

Meeting Date: 11/19/10-11/19/10

Meeting Details:

On November 19, the Committee will discuss current FDA recommendations for Testing of Replication Competent Retrovirus (RCR)/Lentivirus (RCL) in Retroviral and Lentiviral Vector Based Gene Therapy Products.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 12/11/08-12/11/08

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for the FC2 Female Condom, sponsored by the Female Health Company. This device is indicated to help prevent HIV/AIDS and unintended pregnancy.

 

       
Location: Gaithersburg Holiday Inn Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPostponed: Obstetrics and Gynecology Devices Panel

Meeting Date: 5/16/08-5/16/08

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for the FC2 Female Condom, sponsored by the Female Health Co. This device is indicated to help prevent HIV/AIDS and unintended pregnancy.

 

       
Location: Holiday Inn Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 12/13/07-12/14/07

Meeting Details:

On December 13, 2007, the committee will discuss, make recommendations, and vote on a premarket approval application for the Adiana Transcervical Sterilization System, sponsored by Cytyc Surgical Products. This device is indicated to be used as a permanent method for female sterilization. On December 14, 2007, the committee will have a general topic discussion of clinical trial design issues for endometrial ablation devices indicated for pre-menopausal women in whom childbearing is complete and who no longer desire menses (i.e., monthly period). The committee will also hear and discuss a post-approval study update for the ExAblate 2000 System from InSightec, Inc. The system is indicated for ablation of uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 8/29/06-8/29/06

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a non-invasive device for use as a complement to clinical breast examination in asymptomatic women between the ages of 30-39.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 3/28/06-3/28/06

Meeting Details:

On March 28, 2006, the committee will have a general topic discussion of clinical trial design issues for new devices intended to treat symptomatic uterine fibroids.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-3:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 3/27/06-3/27/06

Meeting Details:

On March 27, 2006, the committee will discuss, make recommendations, and vote on a premarket approval application for a post surgical adhesion prevention device for use in patients undergoing gynecological laparoscopic surgical procedures.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 10:00AM-5:45PM    
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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 6/23/05-6/23/05

Meeting Details:

The committee will hear a presentation on the FDA Critical Path Initiative. The committee will also discuss, make recommendations, and vote on a premarket approval application for a fetal heart monitoring device that, in addition to standard features, is used during labor and delivery to measure, display, and analyze the ST waveform, of the fetal electrocardiogram.

 

       
Location: Holiday Inn Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 5/17/05-5/17/05

Meeting Details:

The committee will hear 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, make recommendations, and vote on a premarket approval application for a spectroscopy-based cervical imaging system intended for use as an adjunct to colposcopy to enhance the identification and selection of biopsy sites.

 

       
Location: HOL - GB Related News Links: Not Available
Time: 8:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsCancelled - Obstetrics and Gynecology Devices Panel

Meeting Date: 10/25/04-10/25/04

Meeting Details:

The committee will discuss and make recommendations on the type of pivotal study needed to support a premarket approval application for fetal monitors that use neural networks for risk assessment.

 

       
Location: Gaithersburg , MD Related News Links: Not Available
Time: 10:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 6/3/04-6/3/04

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a system that ablates uterine fibroids using focused ultrasound under the guidance of magnetic resonance.

 

       
Location: HI, GB Related News Links: Not Available
Time: 8:30AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 6/10/03-6/10/03

Meeting Details:

On June 10, 2003, the committee will discuss, make recommendations, and vote on a premarket approval application for an endometrial ablation device.

 

       
Location: Hilton DC North - Gaithersburg Related News Links: Not Available
Time: 8:30AM-4:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 7/22/02-7/22/02

Meeting Details:

On July 22, 2002, the committee will hear a presentation on post-market surveillance of vacuum assisted delivery devices. The committee will also discuss, make recommendations, and vote on a premarket approval application for a permanent contraceptive device. Background information, including the agenda and questions for the committee, will be available to the public one business day before the meeting on the Internet at http://www.fda.gov/cdrh/panelmtg.html. Material for the July 22 session will be posted on July 19, 2002.

 

       
Location: DoubleTree Hotel Rockville, MD Related News Links: Not Available
Time: 8:30AM-5:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 4/22/02-4/22/02

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for an intrapartum fetal monitor.

 

       
Location: TBA Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 5/21/01-5/22/01

Meeting Details:

On May 21, 2001, the committee will discuss a supplement to a premarket approval application (PMA) for an intrapartum fetal pulse oximeter. The committee will also hear a presentation on the clinical trial of an intrapartum fundal pressure belt intended to reduce the incidence of operative deliveries. On May 22, 2001, in the morning session, the committee will discuss air and gas emboli associated with operative hysteroscopy. In the afternoon session, the committee will discuss uterine artery embolization.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 1/29/01-1/29/01

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for an endometrial ablation device.

 

       
Location: Gaithersburg, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices

Meeting Date: 1/24/00-1/25/00

Meeting Details:

On January 24, 2000, the committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for a fetal pulse oximeter. On January 25, 2000, the committee will discuss a draft guidance document on adhesion barrier products intended for use in pelvic and/or abdominal surgery.

 

       
Location: Gaithersburg Holiday Inn Gaithersburg, MD. Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices

Meeting Date: 10/4/99-10/4/99

Meeting Details:

On October 4, 1999, in the morning session, the committee will discuss issues for new barrier contraceptive devices, such as premarket study design, prescription versus over-the-counter availability, and premarket versus postmarket studies. The following current guidance documents are available as references: (1) Testing Guidance for Male Condoms Made from New Material; (2) Guidance for Industry: Uniform Contraceptive Labeling; and (3) Premarket Testing Guidelines for Female Barrier Contraceptive Devices Also Intended to Prevent Sexually Transmitted Diseases.

 

       
Location: Parklawn Bldg. 5600 Fishers Lane Rockville, MD. Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices

Meeting Date: 10/19/98-10/19/98

Meeting Details:

Premarket Approval Application (P980032) Valleylab will summarize its PMA for the VestaTM DUB Treatment System for thermal endometrial ablation.

 

       
Location: FDA Parklawn Building Rockville, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 9/14/16-9/14/16

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Meeting Details:

The committee will discuss new drug application 208714, apaziquone for intravesical instillation, application submitted by Spectrum Pharmaceuticals, Inc. The proposed indication (use) for this product is for immediate intravesical instillation post-transurethral resection of bladder tumors in patients with non-muscle invasive bladder cancer.

 

       
Location: Conference Center Related News Links: Not Available
Time: 8:00AM-1:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Meeting: Psychopharmacologic & DSRM Drugs AdComm

Meeting Date: 9/14/16-9/14/16

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Meeting Details:

The committees will discuss a completed postmarketing-requirement randomized, placebo controlled trial of the neuropsychiatric effects of CHANTIX (varenicline), ZYBAN (bupropion), and nicotine replacement therapy, along with relevant published observational studies to determine whether the findings support changes to product labeling.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Meeting-Anesthetic and Analgesic Drug Products AC, the DSRM AC, and the Pediatric AC

Meeting Date: 9/15/16-9/16/16

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Meeting Details:

The purpose of this public advisory committee meeting is to discuss the appropriate development plans for establishing the safety and efficacy of prescription opioid analgesics for pediatric patients, including obtaining pharmacokinetic data and the use of extrapolation.

 

       
Location: TBD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 9/20/16-9/21/16

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Meeting Details:

On September 20 and 21, 2016, the Committee will discuss and make recommendations regarding the classification of certain wound care products containing antimicrobials and other drugs as part of the routine process for device classification. These products are regulated under product code FRO, "Dressing, Wound, Drug," and are considered "pre-amendments" because they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments were enacted, and have not yet been classified under section 513 of the Federal Food, Drug, and Cosmetic Act. As a part of the classification process, FDA is seeking committee input on the indications for use, risks to health, and safety and effectiveness of these wound care products, and how they should be classified. They may be classified in class I (general controls), class II (special and general controls), or class III (premarket approval (PMA), requiring demonstration of safety and effectiveness for each product). FDA believes some of these products may meet the definition of class II whereas others may meet the definition of class III in light of their intended use, composition, the extent of evidence of clinical benefit, and the risks they pose. For the subset of the these products that contain antibiotics, FDA appreciates the importance of appropriately addressing the risk of antimicrobial resistance (AMR) in light of the increasingly significant national public health concern posed by AMR. FDA is also aware of differences in the claims made for some products even though they may be regulated in the same manner.

 

       
Location: Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Anesthetic & Analgesic & DSRM Drug Adcomm

Meeting Date: 10/5/16-10/5/16

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Meeting Details:

The committees will be asked to discuss naloxone products intended for use in the community, specifically the most appropriate dose or doses of naloxone to reverse the effects of life-threatening opioid overdose in all ages, and the role of having multiple doses available in this setting. The committees will also be asked to discuss the criteria prescribers will use to select the most appropriate dose in advance of an opioid overdose event and the labeling to inform this decision, if multiple doses are available.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting of the Bone, Reproductive and Urologic Drugs Advisory Committee

Meeting Date: 10/19/16-9/19/16

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Meeting Details:

The committee will discuss the efficacy and safety of new drug application (NDA) 201656 (desmopressin), 0.75 mcg/0.1 mL and 1.5 mcg/0.1 mL nasal spray, submitted by Serenity Pharmaceuticals, LLC, for the proposed treatment of adult onset nocturia.

 

       
Location: tbd Related News Links: Not Available
Time: 8:15AM-6:00PM    
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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMicrobiology Devices Panel of the Medical Devices Advisory Committee

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

Meeting Details:

On August 16, 2016, the committee will discuss and make recommendations regarding the appropriateness of clearing or approving of over-the-counter (OTC) diagnostic tests for the detection of pathogens causing infectious diseases, focusing on respiratory and sexually transmitted infections (STI). Currently, there are no OTC diagnostic tests for infectious diseases cleared or approved by CDRH. The committee will evaluate the risks and benefits to individual patients and to public health associated with clearing or approving OTC diagnostic tests for infectious diseases. Serious risks such as false negative results, false positive results, patient loss to medical followup, and the impact on surveillance of reportable infections will be addressed. Potential benefits such as reduction of infection transmission and increased access to testing will be discussed as well. The committee will also make recommendations on clinical study design, analytical study design, and acceptable performance criteria applicable to respiratory and STI diagnostic devices.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsClinical Chemistry & Clinical Toxicology Devices Panel of the Medical Devices AdComm

Meeting Date: 8/10/16-8/10/16

Meeting Details:

On August 10, 2016, the committee will discuss, make recommendations, and vote on information regarding a de novo request for the SEEKER Newborn Screening System (SEEKER System), by Baebies, Inc. The SEEKER System consists of the SEEKER Analyzer, the SEEKER 4-Plex Assay Kit, the SEEKER Cartridges, the Spot Logic software, and quality control materials; it uses digital microfluidic technology to measure multiple lysosomal enzymatic activities quantitatively from newborn dried blood spot specimens.

 

       
Location: Gaithersburg Holiday Inn Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Anesthetic and Analgesic Drug Products AdComm and the DSRM AdComm

Meeting Date: 8/4/16-8/4/16

Meeting Details:

The committees will discuss new drug application (NDA) 208630, morphine sulfate extended-release tablets, submitted by Egalet U.S., Inc., with the proposed indication of the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. It has been formulated with the intent to provide abuse-deterrent properties. The committees will be asked to discuss whether the data submitted by the applicant are sufficient to support labeling of the product with the properties expected to deter abuse.

 

       
Location: tbd Related News Links: Not Available
Time: 9:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsCellular, Tissue, and Gene Therapies Advisory Committee

Meeting Date: 7/26/16-7/26/16

Meeting Details:

On July 26, 2016, the committee will meet by teleconference. In open session, the committee will hear updates of research programs in the Laboratory of Molecular Oncology and the Laboratory of Biological Chemistry, Division of Biotechnology Review and Research 1 and 4, Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research, FDA.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 1:00PM-3:30PM    
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Past Meetings

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

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