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This draft guidance identifies the cybersecurity information FDA considers to generally be necessary for cyber devices under section 524B of the FD&C Act.
Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards
This guidance updates the Small Business Guidance including describing how FDA plans to implement the small business registration and listing fee waiver.
This guidance is intended to provide recommendations for collecting a representative sample for testing when fish and fishery products are subject to detention without physical examination (DWPE) due to the appearance of adulteration caused by pathogens.