FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: CONSIDERATION OF ENFORCEMENT POLICIES FOR IN VITRO DIAGNOSTIC TESTS DURING A SECTION 564 DECLARED EMERGENCY; GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF; AVAILABILITY

WASHINGTON, Sept. 23 -- Food and Drug Administration has issued a notice called: Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency; Guidance for Industry and Food and Drug Administration Staff; Availability.

The notice was published in the Federal Register on Sept. 23 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency." This guidance describes the factors FDA intends to assess in deciding whether to issue an enforcemen...