CDRH Standards Program
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1 Standards Scott Colburn Deputy Director Standards Management Staff FDA/CDRH/OSEL 1 CDRH Standards Program Standards needs/priorities New projects Travel / Travel priorities Standards review Standards ballot execution Standards recognition Liaison representative accreditation Membership in SDOs License agreements for access to published standards 2
2 CDRH Standards Program Participate in approximately 550 standard committees ~ 250 staff participating in standards ~ 940 currently recognized standards 3 Specialty Task Groups (STGs) Serve as a coordinating and advisory resource to the development and management of standards responsive to the regulatory needs of CDRH Anesthesia Biocompatibility Cardiology Dental/ENT/Neurology General General Hospital/ General Plastic Surgery IVDs Materials Nanotechnology OB-BYN/Gastroenterology Ophthalmic Orthopedics/Physical Medicine Radiology Software Sterility Tissue Engineering 4
3 Use of Consensus Standards by Federal Agencies Codified in Public Law National Technology Transfer and Advancement Act of 1995 Interpreted by OMB Circular A (currently being revised) Implemented by NIST Food & Drug Administration Modernization Act (FDAMA) 5 Food & Drug Administration Modernization Act (FDAMA) Section 514 (21 U.S.C. 360d) is amended by adding: by publication in the Federal Register, recognize all or part of an appropriate standard established by a nationally or internationally recognized standard development organization for which a person may submit a declaration of conformity in order to meet a premarket submission requirement or other requirement under this Act to which such standard is applicable. 6
4 Declaration of Conformity What does it mean? Conformance Equivalence Conformance Clearance Conformance Approval 7 Why Standards (besides the law)? Improve time to market for safe and effective medical devices and other health care products Facilitates product design and performance Continually raises the bar on safety and effectiveness Serves as education for FDA staff and industry 8
5 Why Use FDA Recognized Consensus Standards? Facilitates the premarket review process Conformance with Recognized Consensus Standards can provide reasonable assurance of safety and effectiveness for many aspects of medical device evaluation. Standards produce voluntary consensus among industry, health care device users and FDA. Standards are updated as technology and experience advance 9 Supplemental Information Sheet (SIS) Provides CDRH s current view on the use of a recognized standard Products, processes, regulations, codes, contact Extent of Recognition identifies use and/or limitations, additions, etc. related to standard s content 10
6 Where did Form 3654 come from? Revision of the 510(k) paradigm Want to encourage the use of standards in Abbreviated 510(k)s as well as other submissions Meant to assist the reviewer find and assess the use of standards in the submission Meant to assist the standards program meet the needs of the reviewer and the medical device industry 11 STANDARDS DATA REPORT FOR 510(k)s - FDA Form 3654 Available through Device Advice e/default.htm Available through the Standards webpage e/standards/default.htm Available through Standards Guidance documents e/guidancedocuments/default.htm 12
7 Standards Development New(er) technology Tissue engineered devices Interoperability Plug n Play Continuous glucose monitoring Implantable middle ear devices New(er) applications Symbols Human Factors/Usability Small Bore Connectors medical device misconnection 13 Standards Guidances Recognition and Use of Consensus Standards; Final Guidance for Industry and FDA Staff Opportunity to Recommend Standards for CDRH Recognition Frequently Asked Questions on the Recognition of Consensus Standards; Guidance for Industry and for FDA Staff CDRH Standard Operating Procedures for the Identification and Evaluation of Candidate Consensus Standards for Recognition; Final Guidance for Industry 14
8 Information on CDRH Standards Where do you find information about FDA recognized standards and where do you get help in using recognized standards in submissions? RegulationandGuidance/Standards/default.htm 15 Thank You! Scott A. Colburn, MS, BSN, RN Lieutenant Commander, United States Public Health Service Deputy Division Director CDRH Standards Program New Hampshire Ave WO Silver Spring, MD Office:
Standards and Medical Device Regulation Roundtable. Seoul South Korea. 21 October ASTM International
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