1 CONSENSUS STANDARDS OIVD WORKSHOP April 22-23, 2003 Rockville MD Ginette Y. Michaud, M.D. OIVD

2 INTRODUCTION  CDRH recognizes many consensus standards relevant to IVDs  IVD SPECIFIC STANDARDS  GENERIC DEVICE STANDARDS

3 INTRODUCTION IVD SPECIFIC STANDARDS – NCCLS  automation and informatics  clinical chemistry and toxicology  evaluation protocols  general laboratory practices  hematology  immunology and ligand assay  microbiology  molecular methods

4 INTRODUCTION “GENERIC” DEVICE STANDARDS- AAMI, ANSI, CEN, IEC, IEEE, ISO, UL  software  medical device risk management  human factors  electrical safety  electromagnetic compatibility

5 INTRODUCTION CONSENSUS STANDARDS I. Role of consensus standards in IVD premarket review II. FDA’s role in development of STNDs III. Process for FDA recognition of STNDs *Focus on consensus documents

6 I. Role of consensus standards in IVD premarket review  FDA Modernization Act of 1997 –Creates Section 514(c) of the Food, Drug, and Cosmetic Act  FDA recognition of national and international standards (Federal Register)  voluntary conformance by manufacturers to recognized standards  submission of declaration of conformity

7 I. Role of consensus standards in IVD premarket review  Conformity with recognized standards may affect:  safety and effectiveness determinations  IDE, HDE, PMA, PDP  substantial equivalence determinations  510(k)/abbreviated  amount of test data submitted/reviewed  Manufacturer obligated to:  maintain records  submit data upon request

8 I. Role of consensus standards in IVD premarket review  Conformance to STNDs is voluntary  Alternate approaches allowed Refer to:  "Recognition and Use of Consensus Standards; Final Guidance for Industry and FDA". h/cfdocs/cfggp/search.cfm.

9 I. Role of consensus standards in IVD premarket review  Other guidance:  "The New 510(k) Paradigm. Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications, Final Guidance." and  "Frequently Asked Questions on the New 510(k) Paradigm".

10 II. FDA’s role in the development of consensus standards  Significant OIVD participation in standards development organizations (SDOs)  official membership by individuals  informal document reviews

11 II. FDA’s role in the development of consensus standards  FDA SDO participation governed by 21CFR10.95 Participation in outside standard-setting activities. –FDA encourages participation if in the public interest –CDRH supports participation through the CDRH Standards Program –Individual participation by invitation

12 II. FDA’s role in the development of consensus standards  Organization must meet minimum standards as an SDO: –activity based on sound scientific and technological information; –revisions on the basis of new information; –goal to protect the public against unsafe, ineffective, or deceptive products or practices; –activity not for economic benefit of any group; –activity not involving specific approval of individual products; –existence of commenting procedure.

13 II. FDA’s role in the development of consensus standards  FDA official participation restricted to organizations that meet requirements  Standards are considered for FDA recognition only if developed in conformance with requirements

14 II. FDA’s role in the development of consensus standards OIVD participation in standards development: OIVD participation in standards development:  NCCLS  ISO  GHTF

15 II. FDA’s role in the development of consensus standards NCCLS:  international, voluntary, consensus SDO  Goal: to “enhance the value of medical testing...through the development and dissemination of standards, guidelines, and best practices”

16 II. FDA’s role in the development of consensus standards NCCLS Participation:  proposal of new standards projects  committee writing assignments  commenting on documents  voting on proposed standards

17 II. FDA’s role in the development of consensus standards International Organization for Standardization/ISO: International Organization for Standardization/ISO:  Voluntary, consensus SDO; non- governmental federation of national SDOs, covering all technical fields except electrical  Mission: to promote international standardization to reduce technical barriers to trade

18 II. FDA’s role in the development of consensus standards ISO: ISO:  ~200 technical committees each for different technical areas  OIVD participates in ISO TC 212 Clinical laboratory testing and in vitro diagnostic test systems

19 II. FDA’s role in the development of consensus standards ISO TC 212: ISO TC 212:  Goal: standardization in laboratory medicine and IVD test systems  3 working groups: –WG 1Quality management in the clinical laboratory –WG 2 Reference systems –WG 3 In vitro diagnostic products

20 II. FDA’s role in the development of consensus standards ISO TC 212: ISO TC 212:  4 completed standards: –medical laboratory quality and competence –reference measurement procedures –reference materials –labeling of staining reagents

21 II. FDA’s role in the development of consensus standards ISO TC 212: ISO TC 212:  Standards under development:  laboratory safety  requirements for reference measurement laboratories  metrological traceability

22 II. FDA’s role in the development of consensus standards ISO TC 212: ISO TC 212:  Documents under development (continued):  requirements for blood glucose self- testing systems  specifications for self-testing Prothrombin Time instruments  quality management of point of care testing

23 II. FDA’s role in the development of consensus standards Global Harmonization Task Force (GHTF): Global Harmonization Task Force (GHTF):  voluntary multi-national organization  representatives: medical device regulatory authorities and industry associations  Goal: harmonization and convergence of medical device regulatory practices

24 II. FDA’s role in the development of consensus standards GHTF:  publishes harmonized documents on regulatory practices & definitions  for use by emerging economies and developed nations  4 Study Groups focused on all phases of product life cycle

25 II. FDA’s role in the development of consensus standards GHTF:  Harmonization projects:  premarket regulatory practices,  standardized premarket submission format,  labeling requirements  data collection  post-market surveillance reporting systems  quality system requirements  medical device auditing processes

26 II. FDA’s role in the development of consensus standards  CDRH active in all Study Groups (SG); OIVD active in SG 1  SG1: operational aspects of medical device regulation including IVD products Current IVD harmonization projects:  classification  labeling  IVD premarket conformity with principles for safety and performance

27 III. Process for FDA Recognition of Consensus Standards  62 IVD Standards recognized by CDRH (NCCLS)  numerous non-IVD standards recognized

28 III. Process for FDA Recognition of Consensus Standards  Mechanisms for proposing CDRH recognition of consensus standards: 1. Proposals by CDRH Specialty Task Groups (STG) 2. Proposals submitted by outside persons and considered by STG  Publication in Federal Register

29 III. Process for FDA Recognition of Consensus Standards  Specialty Task Groups:  Review previously recognized Standards for relevance  Prepare list of priorities for new projects  Propose the revision of existing consensus documents

30 CONCLUSION  OIVD acknowledges the importance of consensus standards:  impact on safety & effectiveness  greater premarket requirement transparency  review of submissions facilitated  Active OIVD participation in development & recognition of STNDs