This week, we will continue looking at some of the background information relating to the FDA Guidance Documents.
This content is from the eCFR and is authoritative but unofficial.
| (a) | What are good guidance practices? Good guidance practices (GGPs) are the FDA's policies and procedures for developing, issuing, and using guidance documents. |
| (b) | What is a guidance document? |
| | (1) | Guidance documents are documents prepared for FDA staff, applicants/sponsors, and the public that describe the agency's interpretation of or policy on a regulatory issue. |
| | (2) | Guidance documents include, but are not limited to, documents that relate to: The design, production, labeling, promotion, manufacturing, and testing of regulated products; the processing, content, and evaluation or approval of submissions; and inspection and enforcement policies. |
| (c) | What other terms have a special meaning? |
| | (1) | "Level 1 guidance documents" include guidance documents that:
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| | (i) | Set forth initial interpretations of statutory or regulatory requirements; |
| | (ii) | Set forth changes in interpretation or policy that are of more than a minor nature; |
| | (iii) | Include complex scientific issues; or |
| | (iv) | Cover highly controversial issues. |
| | (2) | "Level 2 guidance documents" are guidance documents that set forth existing practices or minor changes in interpretation or policy. Level 2 guidance documents include all guidance documents that are not classified as Level 1. |
| | (3) | "You" refers to all affected parties outside of the FDA.
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| (d) | Are you or the FDA required to follow a guidance document? |
| | (1) | No. Guidance documents do not establish legally enforceable rights or responsibilities. They do not legally bind the public or the FDA. |
| | (2) | You may choose to use an approach other than the one set forth in a guidance document. However, your alternative approach must comply with the relevant statutes and regulations. The FDA is willing to discuss an alternative approach with you to ensure that it complies with the relevant statutes and regulations. |
| | (3) | Although guidance documents do not legally bind the FDA, they represent the agency's current thinking. Therefore, FDA employees may depart from guidance documents only with appropriate justification and supervisory concurrence.
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| (e) | Can the FDA use means other than a guidance document to communicate new agency policy or a new regulatory approach to a broad public audience? |
| | The agency may not use documents or other means of communication that are excluded from the definition of guidance document to informally communicate new or different regulatory expectations to a broad public audience for the first time. These GGPs must be followed whenever regulatory expectations that are not readily apparent from the statute or regulations are first communicated to a broad public audience.
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| (f) | How can you participate in the development and issuance of guidance documents? |
| | (1) | You can provide input on guidance documents that the FDA is developing under the procedures described in paragraph (g) of this section. |
| | (2) | You can suggest areas for guidance document development. Your suggestions should address why a guidance document is necessary. |
| | (3) | You can submit drafts of proposed guidance documents for the FDA to consider. When you do so, you should mark the document "Guidance Document Submission" and submit it to Division of Dockets Management (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. If you wish to submit the draft of a proposed guidance document electronically, submit it through https://www.regulations.gov at Docket No. FDA-2013-S-0610. It is only necessary to submit one copy. |
| | (4) | You can, at any time, suggest that the FDA revise or withdraw an already existing guidance document. Your suggestion should address why the guidance document should be revised or withdrawn and, if applicable, how it should be revised. |
| | (5) | Once a year, the FDA will publish, both in the Federal Register and on the Internet, a list of possible topics for future guidance document development or revision during the next year. You can comment on this list (e.g., by suggesting alternatives or making recommendations on the topics that the FDA is considering). |
| | (6) | To participate in the development and issuance of guidance documents through one of the mechanisms described in paragraphs (f)(1), (f)(2), or (f)(4) of this section, you should contact the center or office that is responsible for the regulatory activity covered by the guidance document. |
| | (7) | If the FDA agrees to draft or revise a guidance document, under a suggestion made under paragraphs (f)(1), (f)(2), (f)(3) or (f)(4) of this section, you can participate in the development of that guidance document under the procedures described in paragraph (g) of this section. |
Continued next week.
