Daily Rules, Proposed Rules, and Notices of the Federal Government
Submit written comments concerning this draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to
This draft guidance document provides recommendations on preparing and reviewing PMAs and 510(k) submissions for pharmacogenetic and other human genetic tests, whether testing is for single markers or for multiple markers simultaneously (multiplex tests). Tests of gene expression and tests for non-heritable (somatic) mutations are not specifically addressed, although many of the same principles may apply. Likewise, this draft guidance specifically addresses only nucleic-acid based analysis, but some of the principles may be applied to other matrices (e.g., protein), when the purpose is to provide genetic information.
FDA issued an earlier version of this draft guidance on February 27, 2003, entitled “Draft Guidance for Industry and FDA Reviewers; Multiplex Tests for Heritable DNA Markers, Mutations and Expression Patterns.” The notice of availability for the February 27, 2003, draft guidance was published in the
We received several comments on the 2003 draft guidance, which included comments suggesting that the draft guidance was too broad in scope. The 2003 draft guidance document addressed both gene expression and genetic tests. The draft guidance announced in this
In developing the draft guidance announced in this document, FDA considered the comments received on the 2003 draft guidance and also information we received through our participation at seminars and workshops with representatives from the drug and device industries, professional societies, laboratory professionals, healthcare providers, and other stakeholders. These seminars and workshops included discussions of the criteria that are important in the analytical and clinical validation of multiplex tests, including pharmacogenetic and genetic assays. These discussions also explored the kind of information the industry might submit to the agency to achieve the least burdensome means of demonstrating substantial equivalence or evaluating safety and effectiveness.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on “Pharmacogenetic Tests and Genetic Tests for Heritable Markers.” It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.
To receive “Pharmacogenetic Tests and Genetic Tests for Heritable Markers” by fax machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a document. Enter the document number (1549) followed by the pound sign (#). Follow the remaining voice prompts to complete your request.
Persons interested in obtaining a copy of the draft guidance may also do so by using the Internet. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts,
This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 807 subpart E have been approved under OMB Control No. 0910-0120; 21 CFR part 814 have been approved under OMB Control No. 0910-0231; 21 CFR part 801 and 21 CFR part 809 have been approved under OMB Control No. 0910-0485.
Interested persons may submit to the Division of Dockets Management (see