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Past Meetings

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    
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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 OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 10/30/14-10/30/14

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Meeting Details:

The committee will discuss new drug application (NDA) 206316, edoxaban tablets, submitted by Daiichi Sankyo, Inc., for the prevention of stroke and systemic embolism (blood clots other than in the head) in patients with nonvalvular atrial fibrillation (A Fib; abnormally rapid and chaotic contractions of the atria, the upper chambers of the heart).

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 11/6/14-11/6/14

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Meeting Details:

During the morning session, the committee will discuss New Drug Application (NDA) 205353, panobinostat capsules, application submitted by Novartis Pharmaceuticals Corporation. The proposed indication (use) for this product is in combination with bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least 1 prior therapy. During the afternoon session, the committee will discuss NDA 206317, ferric pyrophosphate solution, for administration via hemodialysis dialysate, application submitted by Rockwell Medical, Inc. The proposed indications (uses) for this product are for the treatment of iron loss or iron deficiency to maintain hemoglobin in adult patients with hemodialysis-dependent stage 5 chronic kidney disease (CKD 5HD) and to reduce the prescribed dose of erythropoiesis stimulating agent (ESA) required to maintain desired hemoglobin levels.

 

       
Location: The Great Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

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

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Meeting Details:

On November 14, 2014, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the AcrySof® IQ ReSTOR® Multifocal Toric Posterior Chamber Intraocular Lens submitted by applicant Alcon Laboratories, Inc. This intraocular lens combines the optical properties of a +3 diopter multifocal intraocular lens with the optical properties of a toric intraocular lens. The proposed indication for use is: The AcrySof® IQ ReSTOR® Multifocal Toric Posterior Chamber Intraocular Lens (IOL) are intended for primary implantation for the visual correction of aphakia and pre-existing astigmatism secondary to removal of a cataractous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision, reduction of residual refractive cylinder, and increased spectacle independence. The lens is intended to be placed in the capsular bag.

 

       
Location: Hilton/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products AdComm

Meeting Date: 11/24/14-11/25/14

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Meeting Details:

The committee will discuss the risk of serious neurologic adverse reactions associated with epidural steroid injections (ESI) administered to reduce inflammation for pain management. The committee will also consider the efficacy of ESI and the overall risk benefit balance of injecting steroids in the epidural space to treat pain. These considerations will assist the Agency in our discussions of possible regulatory options, including but not limited to changes to the 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 OptionsAnti-Infective Drug AdComm

Meeting Date: 12/4/14-12/4/14

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Meeting Details:

The committee will discuss issues related to clinical development programs and clinical trial designs for antibacterial products for the treatment of patients with serious bacterial infections for which there are limited or no therapeutic options.

 

       
Location: The Marriott Inn and Conference Center Related News Links: Not Available
Time: 8:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

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

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Meeting Details:

On December 12, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Superion InterSpinous Spacer device sponsored by Vertiflex Incorporated. The proposed Indication for Use for the Superion InterSpinous Spacer device, as stated in the PMA, is as follows: the Superion InterSpinous Spacer (the Superion ISS) is intended to treat skeletally mature patients suffering from pain, numbness, and/or cramping in the legs (neurogenic intermittent claudication) secondary to a diagnosis of moderate lumbar spinal stenosis, with or without Grade 1 spondylolisthesis, confirmed by X-ray, MRI and/or CT evidence of thickened ligamentum flavum, narrowed lateral recess, and/or central canal or foraminal narrowing. The Superion ISS is indicated for those patients with impaired physical function who experience relief in flexion from symptoms of leg/buttock/groin pain, numbness, and/or cramping, with or without back pain. The Superion ISS may be implanted at one or two adjacent lumbar (L) levels in patients in whom treatment is indicated at no more than two levels, from L1 to L5.

 

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

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 10/21/14-10/21/14

Meeting Details:

The committee will discuss supplemental new drug application (sNDA) 203188, ivacaftor oral tablets, submitted by Vertex Pharmaceuticals Inc., for the treatment of cystic fibrosis in patients with an R117H mutation in the cystic fibrosis transmembrane conductance regulator gene.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs AdComm

Meeting Date: 10/20/14-10/20/14

Meeting Details:

The committee will discuss biologics license application (BLA) 125504, secukinumab, a human monoclonal antibody, submitted by Novartis, proposed for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Psychopharmacologic Drugs & DSRM

Meeting Date: 10/16/14-10/16/14

Meeting Details:

The committees will discuss the risk of serious neuropsychiatric adverse events with CHANTIX (varenicline tartrate) tablets, NDA 21928, Pfizer, Inc., and discuss options for addressing this risk.

 

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

Meeting Date: 10/8/14-10/9/14

Meeting Details:

On October 8, the committee will discuss, make recommendations and vote on information related to the premarket approval application regarding the Boston Scientific Corporation’s WATCHMAN Left Atrial Appendage (LAA) Closure Technology. FDA is seeking committee review and recommendations regarding new clinical data and associated additional adverse events including stroke that have become available since the previous advisory committee meeting on the WATCHMAN device, which was held December 11, 2013. The WATCHMAN LAA Closure Technology is a percutaneously delivered permanent cardiac implant placed in the left atrial appendage. This device is indicated to prevent thromboembolism (TE) from the left atrial appendage. It may be considered for use in patients with non-valvular atrial fibrillation who are eligible for warfarin therapy to reduce the risk of stroke and systemic embolism based on CHADS2 (congestive heart failure, hypertension, age >75 years, diabetes, and prior stroke or transient ischemic attack (TIA)) or CHA2DS2-VASc (congestive heart failure, hypertension, age >75 years, diabetes mellitus, stroke/TIA/TE, vascular disease, age 65-74, and sex category) scores. On October 9, the committee will discuss and make recommendations regarding the classification of more-than-minimally manipulated allograft heart valves (MMM Allograft HVs). A MMM Allograft HV is a human valve or valved conduit that has been aseptically recovered from qualified donors, dissected free from the human heart, and then subjected to a manufacturing process(es) that alters the original relevant characteristics of the tissue (21 CFR 1271.3(f), 21 CFR 1271.10(a)(1), and 21 CFR 1271.20). The valve is then stored until needed by a recipient. An example of such a manufacturing process is one that intentionally removes the cells and cellular debris with the goal of reducing in vivo antigenicity. MMM Allograft HVs are considered preamendment devices because they were found substantially equivalent to devices in commercial distribution prior to May 28, 1976, when the Medical Device Amendments became effective. MMM Allograft HVs are currently regulated under Product Code OHA, ‘‘Heart Valve, More than Minimally Manipulated Allograft,’’ as unclassified devices and reviewed under the premarket notification, 510(k), authority (21 CFR part 807). FDA is seeking committee input on the safety and effectiveness of MMM Allograft HVs and the regulatory classification for MMM Allograft HVs.

 

       
Location: Hilton Gaithersburg MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 10/1/14-10/1/14

Meeting Details:

On October 1, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the SONABLATE 450 device sponsored by SonaCare Medical, LLC. The proposed Indication for Use for the SONABLATE 450 device, as stated in the PMA, is as follows: The SONABLATE 450 (SONABLATE) is intended for use in the treatment of localized, clinically recurrent prostate cancer after failure of primary external beam radiation therapy.

 

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