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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Anesthetic &Analgesic with DSRM AdComm

Meeting Date: 12/17/18-12/18/18

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Meeting Details:

The committees will provide input and advice on strategies to increase the availability of naloxone products intended for use in the community. The committees will be asked to consider various options for increasing access to naloxone, weighing logistical, economic, and harm reduction aspects and whether naloxone should be co-prescribed with all or some opioid prescriptions to reduce the risk of overdose death. Because of the potential, significant costs and burdens that may be associated with naloxone co-prescribing (e.g., economic costs to consumers and health systems, adjusting to manufacturing volume growth, drug shortages), the committees will also be asked to consider the potential burdens that may be associated with naloxone co-prescribing for all or some prescription opioid patients.

 

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

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel - - Sponsor: Impulse Dynamics, Inc.

Meeting Date: 12/4/18-12/5/18

Meeting Details:

On December 4, 2018, the committee will discuss, make recommendations, and vote on information regarding the premarket application (PMA) for the OPTIMIZER SMART Implantable Pulse Generator device, sponsored by Impulse Dynamics (USA), Inc. This first-of-a-kind device is indicated to provide cardiac contractility modulation for class III heart failure patients who are not responding to optimal medical therapy. On December 5, 2018, the committee will discuss and make recommendations regarding issues relating to the emergence of medical devices, which aim to treat hypertension. Currently, clinical studies to evaluate the safety and effectiveness of these devices are progressing. FDA requests panel input regarding the potential indications and labeling for devices intended to treat hypertension and optimal study designs needed to evaluate the potential benefits and risks while considering issues such as medication compliance, patient perspective, and appropriate study controls.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPatient Engagement AdComm

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

Meeting Details:

On November 15, 2018, the Committee will discuss and make recommendations on the topic “Connected and Empowered Patients: e-Platforms Potentially Expanding the Definition of Scientific Evidence.” The recommendations will address how FDA can leverage patient-driven platforms, such as social media and registries, to better engage patients and consumers as empowered partners in the work of protecting public health and promoting responsible innovation. Social media and other web platform enablers are facilitating the growth of virtual patient communities. Increasingly, patients and health care consumers are using these platforms to share their health experiences and seek information from other patients and consumers, rather than their health care providers alone. Novel approaches and methodologies are being used to tap into some of these platforms as potentially rich sources of patient-generated health data, which could be used as relevant and reliable real-world evidence. This meeting will help advance FDA’s objective to assure the needs, experiences, and perspectives of patients are included as part of FDA’s deliberations involving the regulation of medical devices and their use by patients. For this meeting, FDA is seeking input from the Committee and the public on whether and how FDA can harness the emerging potential of these patient platforms to better engage patients and consumers as empowered partners in the work of protecting public health and promoting responsible innovation. In addition, FDA is seeking recommendations from the Committee on ways to leverage these platforms to disseminate as well as potentially collect and evaluate health information to and from patients and consumers.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic & Analgesic Drug Products AdComm

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

Meeting Details:

The committee will discuss the assessment of opioid analgesic sparing outcomes in clinical trials of acute pain. The committee will be asked to comment on the trial design and endpoints of these studies and how to determine the clinical relevance of the results.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Anesthetic & Analgesic with DSRM AdComm - Sponsor: SpecGX Inc.

Meeting Date: 11/14/18-11/14/18

Meeting Details:

The committees will discuss new drug application (NDA) 209774, for an immediate-release oral tablet formulation of oxycodone, which is intended to resist common methods of physical or chemical manipulation and to deter intravenous and intranasal abuse, submitted by SpecGx Inc., for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The committees will also be asked to determine whether the Applicant adequately demonstrated that the abuse-deterrent properties of the proposed product are sufficient to include this information in the product label, and whether the product should be approved.

 

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

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