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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMicrobiology Devices Panel

Meeting Date: 3/8/19-3/8/19

Meeting Details:

On March 8, 2019, the committee will discuss and make recommendations regarding new or alternative approaches to the clinical study design and evaluation of devices detecting Human Papillomavirus (HPV) nucleic acid. These approaches will take into consideration scientific data generated since the approval of the first High Risk (HR) HPV screening device in 2003 as well as the effects of HPV vaccination on clinical studies of devices for HPV detection. Topics to be addressed at the meeting include clinical study design and comparator methods. Additionally, the committee will discuss potential changes to the HR HPV device indications for use considering continually evolving cervical cancer screening guidelines. The committee will provide expert feedback regarding the benefits and risks from the adoption of changes in each of the above topics and make recommendations for future HR HPV device evaluation strategies that are both scientifically rigorous and least burdensome.

 

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

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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    
Materials:
   
       

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Upcoming Meetings

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

Meeting Date: 10/27/20-10/27/20

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Meeting Details:

On October 27, 2020, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Neovasc Reducer System sponsored by Neovasc, Inc. The proposed Indication for Use of the Neovasc Reducer System is for patients suffering from refractory angina pectoris despite guideline directed medical therapy, who are unsuitable for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention.

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 9:00AM-6:00PM    
Materials:
   
       

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 10/22/20-10/22/20

Meeting Details:

On October 22, 2020, the Center for Biologics Evaluation and Research’s (CBER), Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session, to discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19. No specific application will be discussed at this meeting.

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 10:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPatient Engagement Advisory Committee

Meeting Date: 10/22/20-10/22/20

Meeting Details:

On October 22, 2020, the committee will discuss and make recommendations on the topic “Artificial Intelligence (AI) and Machine Learning (ML) in Medical Devices.” Specifically, we will discuss the composition of the datasets on which the software “learns”, components of the device information shared with patients, and factors that impact patient trust in the technology. Large clinical datasets are used to train and improve AI/ML algorithms, allowing transformational improvements in the diagnosis, clinical decision making, and treatment of patients. Devices using AI/ML technology will transform healthcare delivery by increasing efficiency of key processes in the treatment of patients. Health products powered by AI/ML are streaming into our lives, from virtual doctor apps to wearable sensors and drugstore chatbots to algorithms for detecting cancer in mammography and interpretations of chest X rays. Despite the rapid advancement and integration, AI/ML systems may have algorithmic biases, limited generalizability, and lack transparency in their assumptions based on potential limitations of training datasets. The recommendations provided by the committee will address the importance of including various demographic groups in AI/ML algorithm development. The recommendations will also address the impact of the user interface and transparency including what information and how the information about the devices could be communicated to foster patient trust in the AI/ML devices.

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 10:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Psychopharmacologic & DSaRM AdComm

Meeting Date: 10/9/20-10/9/20

Meeting Details:

The committees will discuss the efficacy, safety, and benefit-risk profile of new drug application (NDA) 213378, olanzapine and samidorphan oral tablets, submitted by Alkermes, Inc., for the proposed indications of schizophrenia and bipolar disorder.

 

       
Location: FDA TelCon - Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 10:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsJoint Psychopharmacologic & DSaRM AdComm

Meeting Date: 10/8/20-10/8/20

Meeting Details:

The committees will discuss new drug application (NDA) 211179, for amphetamine sulfate immediate-release oral capsules, submitted by Arbor Pharmaceuticals, LLC, for the proposed indication of treatment of attention deficit hyperactivity disorder. The product has been formulated with properties intended to deter non-oral abuse, and the applicant has submitted data to support these abuse-deterrent properties for this product. The committees will be asked to discuss the overall risk-benefit profile of the product, including the potential public health impact, and whether the applicant has demonstrated abuse-deterrent properties for their product that would support labeling.

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel of the MDAC

Meeting Date: 10/7/20-10/7/20

Meeting Details:

On October 7, 2020, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the TransMedics Organ Care System (OCS)--Heart, by TransMedics, Inc. The proposed Indication for Use for the TransMedics OCS--Heart, as stated in the PMA, is as follows: The TransMedics OCS Heart System is a portable ex-vivo organ perfusion and monitoring system indicated for the resuscitation, preservation, and assessment of donor hearts with one or more of the following characteristics for transplantation into a potential recipient in a near-physiologic, normothermic, and beating state: Expected cross-clamp or ischemic time = 4 hours due to donor or recipient characteristics (e.g., donor-recipient geographical distance, expected recipient surgical time) Donor Age = 55 years Donors with history cardiac arrest and downtime = 20 minutes Donor history of alcohol use Donor LV Ejection Fraction = 50 percent but = 40 percent Donor history of Left Ventricular Hypertrophy (septal or posterior wall thickness of >12 and = 16 millimeters).

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform held via webcast only. Related News Links: Not Available
Time: 9:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products Advisory Committee

Meeting Date: 10/2/20-10/2/20

Meeting Details:

On October 2, 2020, the Center for Biologics Evaluation and Research’s (CBER), Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session to discuss and make recommendations on selection of strains to be included in an influenza virus vaccine for the 2021 southern hemisphere influenza season.

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 11:00AM-3:30PM    
Materials:
   
       

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Past Meetings

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