U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Assay Migration Studies for In Vitro Diagnostic Devices
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Assay Migration Studies for In Vitro Diagnostic Devices Guidance for Industry and FDA Staff April 2013

Download the Final Guidance Document
Final
Docket Number:
FDA-2008-D-0642
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance outlines FDA’s regulatory approach for approval of Class III in vitro diagnostic devices, as well as certain licensed or certain cleared in vitro diagnostic devices in cases, when a previously approved, licensed, or cleared assay is migrating (i.e., transitioning) to another system for which assay performance has not been evaluated by FDA. In this guidance the term “new system” refers to the system (assay, instrument, and software) to which the assay is migrating from a previously approved/licensed/cleared system. The term “old system” refers to the system (assay, instrument and software) which was approved/licensed/cleared from which the assay is migrating to a currently unapproved/unlicensed/uncleared system.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2008-D-0642.

Back to Top