Guidance Documents. As defined in section 202-e of the State Administrative Procedure Act, a guidance document is any guideline, memorandum or similar document, prepared by an agency, that provides general information or guidance to assist regulated parties in complying with any statute, rule or other legal requirement. Activities' Guidance Details. Authority: Executive Ord er No. 20-66, ORS 433.441, ORS 433.443, ORS 431A.010. Apple macbook how much. Enforcement: To the extent this guidance requires compliance with certain provisions, it is enforceable as specified in Executive Order 20-66.
Guidance documents represent FDA's current thinking on a topic. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.
Guidance documents describe FDA’s interpretation of our policy on a regulatory issue (21 CFR 10.115(b)). These documents usually discuss more specific products or issues that relate to the design, production, labeling, promotion, manufacturing, and testing of regulated products. Guidance documents may also relate to the processing, content, and evaluation or approval of submissions as well as to inspection and enforcement policies.
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This feature is provided to give a convenient way to search for all FDA guidance documents from a single location.
How to Provide Input for Guidance Development
Interested parties have a number of opportunities to provide input into guidance development. For more information please see Opportunities for Input Into Guidance Development (PDF - 21 KB).
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Interested parties also have a number of opportunities to comment on agency rulemaking. For more information please see Comment on Proposed Regulations and Submit Petitions.
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