WASHINGTON, Dec. 4 -- Food and Drug Administration has issued a rule called: Medical Devices; Quality Management System Regulation Technical Amendments.
The rule was published in the Federal Register on Dec. 4 by Lowell M. Zeta, Acting Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA, the Agency, or we) is amending certain medical device regulations to revise references and language in existing Code of Federal Regulations (CFR) provisions to conform with the final rule "Medical Devices; Quality System Regulation Amendments" (QMSR Final Rule). This rule does not impose any new requirements on affected parties. This action is editorial in nature to correct errors, conform...