# Presentation: 016421

## CONSENSUS STANDARDS

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

## INTRODUCTION

- CDRH recognizes many consensus standards relevant to IVDs
- IVD SPECIFIC STANDARDS
- GENERIC DEVICE STANDARDS

## 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

## INTRODUCTION

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

## 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

## 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

## 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

## 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"*.  _http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfggp/search.cfm_.

## 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"*.

## 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

## 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

## 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.

## 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

## II.  FDA’s role in the development of consensus standards

-   OIVD participation in standards development:
- NCCLS
- ISO
- GHTF

## 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”

## 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

## II.  FDA’s role in the development of consensus standards

-    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

## II.  FDA’s role in the development of consensus standards

-   ISO:
- ~200 technical committees each for different technical areas
- OIVD participates in ISO TC 212 *Clinical laboratory testing and in vitro diagnostic test systems*

## II.  FDA’s role in the development of consensus standards

-   ISO TC 212:
- Goal: standardization in laboratory medicine and IVD test systems
- 3 working groups:
- WG 1		Quality management in the   	               clinical laboratory
- WG 2 	Reference systems
- WG 3 	In vitro diagnostic products

## II.  FDA’s role in the development of consensus standards

-   ISO TC 212:
- 4 completed standards:
- medical laboratory quality and competence
- reference measurement procedures
- reference materials
- labeling of staining reagents

## II.  FDA’s role in the development of consensus standards

-   ISO TC 212:
- Standards under development:
- laboratory safety
- requirements for reference measurement laboratories
- metrological traceability

## II.  FDA’s role in the development of consensus standards

-   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

## II.  FDA’s role in the development of consensus standards

-   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

## 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

## 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

## 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

## III. Process for FDA Recognition of Consensus Standards

- 62 IVD Standards recognized by CDRH (NCCLS)
- numerous non-IVD standards        recognized

## III. Process for FDA Recognition of Consensus Standards

- Mechanisms for proposing CDRH  recognition of consensus standards:
- Proposals by CDRH Specialty Task Groups (STG)
- Proposals submitted by outside persons and considered by STG
- Publication in Federal Register

## 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

## 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
- _http://www.fda.gov/cdrh/stdsprog.html_