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Past Meetings

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

Meeting Date: 11/9/16-11/10/16

Meeting Details:

On November 9, 2016, during session one, the committee will discuss and make recommendations regarding the reclassification of quantitative Cytomegalovirus (CMV) viral load devices from class III (Premarket approval) to class II (510(k)). A nucleic acid-based in vitro diagnostic device for the quantitation of CMV viral load, within the context of transplant patient management, is a post-amendment device classified into class III under section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act )(21 U.S.C. 360c(f)(1). To date, the following product code has been established for CMV viral load devices: PAB (CMV DNA Quantitative Assay). During session two, the committee will discuss and make recommendations regarding the appropriate initial classification for qualitative or quantitative viral load devices for Epstein-Barr virus, BK virus, JC virus, Human Herpesvirus 6, and Adenovirus infections. FDA is seeking expert recommendations to assess the potential risks and benefits of these devices when used in patients following solid-organ or stem cell transplantation.

 

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

Meeting Date: 3/12/14-3/12/14

Meeting Details:

On March 12, 2014, the committee will discuss, make recommendations, and vote on a premarket approval application for a new indication for the cobas Human Papillomavirus (HPV) Test, sponsored by Roche Molecular Systems, Inc. The cobas HPV Test is a qualitative in vitro test for the detection of HPV that is currently approved for use in conjunction with cervical cytology. Roche is seeking a claim whereby the cobas HPV Test can be used as a first-line primary cervical screening test. The test utilizes amplification of target DNA by the polymerase chain reaction and nucleic acid hybridization for the detection of 14 high risk (HR) HPV types in a single analysis. The test specifically identifies types HPV 16 and HPV 18 while concurrently detecting the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68). Per the proposed indication, women who test negative for high risk HPV types by the cobas HPV Test would be followed up in accordance with the physician’s assessment of screening and medical history, other risk factors, and professional guidelines. Women who test positive for HPV genotypes 16 and/or 18 by the cobas HPV Test would be referred to colposcopy. Women who test high risk HPV positive and 16/18 negative by the cobas HPV Test (12 other HR HPV positive) would be evaluated by cervical cytology to determine the need for referral to colposcopy.

 

       
Location: College Park Holiday Inn Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMicrobiology Devices Panel

Meeting Date: 6/29/11-6/29/11

Meeting Details:

On June 29, 2011, the committee will discuss and make recommendations regarding the possible reclassification of molecular diagnostics for the rapid detection of Mycobacterium tuberculosis complex and the detection of genetic mutations which confer antibiotic resistance in M. tuberculosis complex. Discussion would include the appropriate information and acceptable performance characteristics that would be required to assess the safety and effectiveness of rapid diagnostic tests for M. tuberculosis complex, and whether these can be sufficiently specified to support possible reclassification.

 

       
Location: Holiday Inn Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMicrobiology Devices Panel

Meeting Date: 3/7/02-3/8/02

Meeting Details:

On March 7, 2002, the committee will discuss and make recommendations on the classification of preamendments in vitro diagnostic products to identify Bacillus anthracis and Yersinia pestis. No applications will be reviewed at this meeting. On March 8, 2002, the committee will discuss, make recommendations, and vote on a supplement to a premarket approval application for a nucleic acid hybridization in vitro diagnostic device for the detection of thirteen high-risk types of human papillomavirus (HPV) DNA in cervical specimens. The test is indicated for use as a general population screening test in conjunction with the Papanicolaou smear for women 30 years of age and older, as an aid to determine the absence of high-grade cervical disease or cancer. The test is not intended for use as a screening test in the general population for women under 30 years of age.

 

       
Location: HOL - GB Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsMicrobiology Devices Panel

Meeting Date: 10/11/01-10/12/01

Meeting Details:

On October 11, 2001, the committee will discuss, make recommendations, and vote on a premarket approval application for an in vitro diagnostic device for the determination of endotoxin activity in human whole blood samples. On the same day the committee will provide advice and recommendations on a premarket notification submission for an in vitro diagnostic device for detecting and measuring urinary tract infection by semiquantitative analysis of volatile compounds released from a urine sample. On October 12, 2001, the committee will discuss, make recommendations, and vote on a premarket approval application for an in vitro diagnostic device for measuring the release of gamma-interferon from sensitized lymphocytes in purified protein derivative (PPD)-stimulated whole blood, as an aid in the diagnosis of latent tuberculosis infection. It is intended to aid in the evaluation of individuals who are suspected of having Mycobacterium tuberculosis infection or disease, have close contact with infected individuals, or originate from an area where tuberculosis is prevalent.

 

       
Location: Hilton, GB Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsMicrobiology Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 12/8/00-12/8/00

Meeting Details:

The committee will discuss and make recommendations on issues concerning the types of information necessary to determine the effectiveness of in vitro diagnostic devices that detect human papilloma virus (HPV) in women 30 years or older when these devices are used: (1) in conjunction with Pap smear to increase the effectiveness of Pap smear screening for cervical cancer, and (2) without Pap smear to determine a woman's risk of cervical cancer. Additionally, the committee will discuss and make recommendations on issues concerning the use of self-collection and alternative specimen sources for the above indications.

 

       
Location: Gaithersburg, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsMicrobiology Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 7/27/00-7/28/00

Meeting Details:

On July 27, 2000, the committee will discuss and make recommendations on issues concerning the appropriate types of data and information required to assess the safety and effectiveness of diagnostic tests intended to identify biothreat agents, or to provide evidence of exposure to biothreat agents, when used on different specimen types and under different conditions for use. On July 28, 2000, the committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for an in vitro diagnostic nucleic acid amplification test for the qualitative detection of hepatitis C virus (HCV) ribonucleic acid (RNA) in human serum or plasma. On the same day the committee will discuss, make recommendations, and vote on a PMA for an automated in vitro diagnostic nucleic acid amplification test for the qualitative detection of HCV RNA in human serum or plasma. These devices are not intended for use in blood or plasma donor screening.

 

       
Location: Gaithersburg Holiday Inn Gaithersburg, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsMicrobiology Devices Panel Meeting

Meeting Date: 1/20/00-1/21/00

Meeting Details:

On January 20, 2000, the committee will discuss, make recommendations, and vote on six premarket approval applications (PMAs) for in vitro diagnostic qualitative devices to detect hepatitis B serological markers in human sera or plasma. The following hepatitis B serological marker assays, when used appropriately in combination, are indicated as an aid in the diagnosis and monitoring of disease and therapy in acute and chronic hepatitis B virus infection (HBV) in both low and high risk adult populations. 1) hepatitis B surface antigen (HBsAg) (HBsAg assay may be used alone as an indicator of HBV infection when performing prenatal testing); 2) antibodies to hepatitis B surface antigen (anti-HBs) (anti-HBs assay may be used alone to determine the immune status of HBV vaccine recipients); 3) hepatitis B e antigen (HBeAg); 4) antibodies to hepatitis B e antigen (anti-HBe); 5) hepatitis B core antigen (anti-HBc); and 6) Immunoglobulin M antibodies to hepatitis B core antigen (IgM anti-HBc). These tests are not intended for blood donor screening. Also, on January 20, 2000, the committee will discuss and make recommendations on issues concerning the use of characterized hepatitis panels in assessing the performance of in vitro diagnostic devices for the determination of hepatitis infection as an alternative to conducting intensive prospective clinical trials. The following draft questions are proposed for discussion and may be subject to changes prior to the committee meeting: 1) Will the use of characterized hepatitis panels provide assurance of the safety and effectiveness of the assay in various populations? 2) What criteria should be used to include specimens in these panels? 3) Will panels be sufficient to support claims for the diagnosis of HBV infection or immunity for all indicated populations? 4) Who should control panel distribution and evaluation, e.g., device manufacturers, FDA, or an independent third party? FDA will consider these recommendations in the future development of review criteria for in vitro diagnostic devices, for the detection of hepatitis antigen or antibodies to hepatitis antigen, as valid scientific evidence to determine whether there is reasonable assurance that these devices are safe and effective. On January 21, 2000, the committee will discuss, make recommendations, and vote on a PMA for an in vitro diagnostic qualitative device for the detection of antibody to hepatitis C virus in human serum or plasma. This device is not intended for use in blood or plasma donor screening.

 

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

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

Meeting Date: 5/20/99-5/21/99

Meeting Details:

On May 20, 1999, the committee will discuss and make recommendations on a premarket notification submission for a qualitative in vitro diagnostic assay intended for the detection of human cytomegalovirus (CMV) DNA in human peripheral white blood cells. The focus of the discussion will be the appropriate use of signal amplification terminology. The committee will also discuss and make recommendations on labeling for the device. Continuing on May 20, 1999, the committee will discuss, make recommendations, and vote on a premarket approval application (PMA) supplement for an in vitro diagnostic target-amplified nucleic acid probe test used for the detection of Mycobacterium tuberculosis complex in sediments prepared from sputum (induced or expectorated), bronchial specimens, or tracheal aspirates. The device as modified is indicated for use of acid-fast bacilli (AFB) smear negative and AFB smear positive respiratory specimens for the diagnosis of active pulmonary tuberculosis disease. On May 21, 1999, the committee will discuss, make recommendations, and vote on a PMA for an in vitro diagnostic qualitative device to detect immunoglobulin G (IgG) antibodies to parvovirus B19 as a marker of previous infection in human serum and plasma. The IgG test is indicated for use in all women where there is a suspicion of exposure to parvovirus B19. The committee will also discuss, make recommendations, and vote on a PMA for an in vitro diagnostic qualitative device to detect IgM antibodies to parvovirus B19 in human serum and plasma. The IgM test is indicated for use in conjunction with the parvovirus B19 IgG enzyme immunoassay to determine immunological status during the first trimester of pregnancy, and for the testing of pregnant women who have sonographic evidence of abnormal fetal development such as hydrops fetalis, or who had an adverse outcome such as fetal death, or premature delivery with fetal abnormalities.

 

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

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products AdComm

Meeting Date: 6/26/18-6/26/18

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Meeting Details:

The committees will discuss new drug application 022324, oxycodone extended-release capsules, submitted by Pain Therapeutics, 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. The product is intended to have abuse-deterrent properties based on its physicochemical 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. Closed Committee Deliberations: On June 26, 2018, from 8 a.m. to 9:30 a.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential commercial information (5 U.S.C. 552b(c)(4)). During this session, the committees will discuss the drug development program of an investigational opioid formulation with properties designed to deter abuse.

 

       
Location: DoubleTree Bethesda, MD Related News Links: Not Available
Time: 9:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 7/25/18-7/25/18

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Meeting Details:

The committee will discuss supplemental biologics license application (sBLA) 125526 for mepolizumab for injection, submitted by GlaxoSmithKline for add-on treatment to inhaled corticosteroid-based maintenance treatment for the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD) guided by blood eosinophil counts.

 

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

Meeting OptionsMeeting OptionsMeeting OptionsPediatric Oncology Subcommittee of the ODAC

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

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

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

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    
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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel of the MDAC

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

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    
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Past Meetings

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