CDRH: Advancing Regulatory Science. Murray Malin, MD Center for Devices and Radiological Health March 29, 2011

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1 CDRH: Advancing Regulatory Science Murray Malin, MD Center for Devices and Radiological Health March 29, 2011

2 Medical Countermeasures Diagnostic and Detection Devices Personal Protective Equipment (PPE) Emergency Devices 2

3 Diagnostic and Detection Products In vitro diagnostic tests used to diagnose and detect influenza and CBRN threat agents Genotypic assays for pathogen identification and antimicrobial drug resistance Diagnostic radiation emitting devices Radiation detection products (e.g.- biodosimetry) 3

4 Personal Protective Equipment Devices intended to reduce exposure to infectious and chemical agents, and other threats (e.g.- N95 Respirators) Devices in the Strategic National Stockpile 4

5 Emergency Devices Ventilators IV administration sets Resuscitation equipment Drug/vaccine delivery systems, needles Other devices in Strategic National Stockpile 5

6 Regulatory Science Activities 6

7 Diagnostic and Detection Devices Developed multiple guidance documents impacting MCM s (e.g.- EUA s, labeling, regulatory pathways, performance characteristics, multiplex nucleic acid assays) Improved transparency by posting clearance reviews on OIVD web site to improve transparency of review process 7

8 Diagnostic and Detection Devices: Inventory of Influenza Devices (2001-present) Investigational Products Product Applications Submitted Products Cleared or Authorized 160 pre-ide s 4 510(k) s (k) s 15 CLIA waivers 18 EUA s 8

9 Diagnostic and Detection Devices: Inventory of Influenza Devices (2001-present) Biothreat Tests Cleared by FDA B. anthracis (5) Y. pestis (1) F. tularensis (3) Brucella spp. (6) Coxiella burnetti/q fever (3) Viral encephalitis (1) Eastern equine encephalitis (1) 9

10 Diagnostic and Detection Devices Collaboration with CDC Clearance of two CDC assays for detection of influenza virus Acceptability of alternative samples to evaluate H5 detection devices Ongoing collaboration with DoD MOU agreement signed by FDA and DoD Pre-EUA review of 73 DoD biothreat tests 4 DoD tests cleared on JBAIDS field lab instrument DoD IVD experts detailed to OIVD 10

11 Personal Protective Equipment Anti-viral respirator cleared (2009) Respirator cleared for general public-use and public health emergencies (2008) Activities to facilitate development of pediatric and general use PPE s Guidance documents 11

12 Emergency Devices Activities facilitating drug/vaccine delivery systems with reduced dead space Shelf Life Extension Program Strategic National Stockpile support 12

13 Regulatory Science Priorities 13

14 Regulatory Science Priorities Develop infrastructure to support development of diagnostics and other MCM s Characterize the medical device supply chain Enable real or near-real time surveillance of supply, utilization and availability of medical devices to avoid shortages Address special needs populations, point-of-care and personalized use of MCM s 14

15 Regulatory Science Priorities Enhance ability to capture, monitor and analyze large datasets Develop innovative statistical tools to develop innovative clinical trials, perform comparative effectiveness research, and perform active surveillance of adverse event reports Develop new tools to evaluate nanotechnology-based devices, including use as diagnostic marker 15

16 Regulatory Science Priorities Increase scientific capacity and expertise to prepare for and facilitate new technologies Develop guidance for development of multiuse products and platforms to expand MCM product pipeline during emergencies 16

17 Regulatory Science Priorities Infrastructure, comparator sequencing database, data processing and resources to enhance reviews of MCM s, facilitate innovative statistical techniques and clinical trials, and development of regulatory pathways for MCM s, including the following: Genomic sequencing devices and assays for the detection of pathogens and antimicrobial drug resistance Multiplex/microarray diagnostic devices capable of simultaneous detection/identification of multiple organisms Agreement with CMS on data necessary for CLIA waiver of authorized products during an emergency 17

18 Regulatory Science Priorities Develop high-performance/scientific computing to facilitate the following: Answer questions related to comparative effectiveness associated with patient subsets Support for genomic sequencing, multiplex devices Identification of improved methods for characterizing failure analysis, validation of factors affecting manufacture of MCM s, and development of forensic evaluation techniques necessary to support multiplatform/product development Develop innovative statistical methods and clinical trial design 18