Research · 10 min read
What an FDA Guidance Document Is, and What It Binds
Companies cite FDA guidance the way people cite law. The regulation that creates guidance documents answers the question directly and in one word: no. They do not legally bind the public or FDA, and knowing that changes how you read a claim built on one.
Key takeaways
- The regulation states directly that guidance documents do not establish legally enforceable rights or responsibilities and do not legally bind the public or FDA.
- A guidance describes the agency's interpretation of, or policy on, a regulatory issue, for FDA staff, applicants and sponsors, and the public.
- Warning letters, press materials, speeches, journal articles and communications to individual firms are expressly excluded from the definition.
- Level 1 guidances carry initial interpretations, more-than-minor policy changes, complex science or high controversy; level 2 is everything else.
- An outside party may use an alternative approach where it complies with the relevant statutes and regulations; FDA staff may depart only with justification and supervisory concurrence.
- A guidance must carry the word guidance, the issuing office, its scope, a prominent nonbinding statement, a date, any revision note, and the word draft where applicable.
- Mandatory words such as must or required are barred from a guidance unless FDA is describing a statutory or regulatory requirement.
- FDA may not use excluded document types to communicate new regulatory expectations to a broad public audience for the first time.
- Anyone may comment on any guidance at any time, suggest revisions or withdrawal, or submit a proposed guidance for consideration.
Answer first: a guidance does not bind anyone
The regulation asks the question in its own heading and then answers it. Are you or FDA required to follow a guidance document?
The answer given is one word, followed by two sentences. No. Guidance documents do not establish legally enforceable rights or responsibilities. They do not legally bind the public or FDA.
That is the whole foundation. Everything else in the section is about how such a document gets made, what it has to look like, and what happens when someone treats it as more than it is.
The regulation also says what a guidance is for. Guidance documents describe the agency's interpretation of, or policy on, a regulatory issue, and they are prepared for FDA staff, applicants and sponsors, and the public.
What counts as a guidance, and what does not
The definition has an inclusion list and an exclusion list, and the exclusion list is the more useful of the two.
Guidance documents include, but are not limited to, documents relating to the design, production, labeling, promotion, manufacturing and testing of regulated products. They also cover the processing, content and evaluation or approval of submissions, and inspection and enforcement policies.
The exclusions are specific. Guidance documents do not include documents relating to internal FDA procedures, agency reports, general information documents provided to consumers or health professionals, speeches, journal articles and editorials, media interviews, or press materials.
Two more exclusions are worth reading twice. Warning letters are excluded from the definition. So are memoranda of understanding and other communications directed to individual persons or firms.
That matters when a document is quoted at you as though it were agency policy. A letter to one company is a communication to that company. The regulation puts it in a different category from a guidance document on purpose.
Level 1 and level 2
Guidance documents come in two classes, and the class decides how much public process a document gets before it takes effect.
Level 1 guidance documents are those that set forth initial interpretations of statutory or regulatory requirements. They also include documents setting forth changes in interpretation or policy that are of more than a minor nature.
Two more triggers put a document at level 1: it includes complex scientific issues, or it covers highly controversial issues.
Level 2 is the residual category. It covers guidance documents that set forth existing practices or minor changes in interpretation or policy, and the regulation says level 2 includes all guidance documents not classified as level 1.
Level 2 documents are posted and implemented immediately unless FDA indicates otherwise, with comment invited afterward. Level 1 documents ordinarily go out in draft first, with a Federal Register notice and an invitation to comment before a final version is issued.
You may take a different approach
This is the paragraph that most changes how a reader should treat a guidance citation.
The regulation states that you may choose to use an approach other than the one set forth in a guidance document. It attaches one condition: the alternative approach must comply with the relevant statutes and regulations.
It also offers a route. FDA is willing to discuss an alternative approach with you to ensure that it complies.
The agency side is not symmetrical. Although guidance documents do not legally bind FDA, the regulation says they represent the agency's current thinking, and FDA employees may depart from them only with appropriate justification and supervisory concurrence.
So the practical asymmetry is worth naming. An outside party may deviate if the law still permits it. An FDA reviewer needs a reason and a supervisor.
How to tell a real guidance document by looking at it
The regulation lists the elements a guidance document must carry, and they work as a checklist for anyone handed one.
It must include the term guidance. It must identify the center or office issuing it. It must identify the activity to which, and the people to whom, the document applies.
It must prominently display a statement of the document's nonbinding effect. It must include the date of issuance.
It must note whether it is a revision to a previously issued guidance and identify the document it replaces. And it must contain the word draft if it is a draft.
One rule about wording is the single most useful line in the section for a lay reader. Guidance documents must not include mandatory language such as shall, must, required or requirement, unless FDA is using those words to describe a statutory or regulatory requirement.
Read that in reverse and it becomes a tool. Where a guidance says must, it is pointing at a statute or a regulation, and that underlying rule is the thing with force. Where it says should, it is describing what the agency currently recommends.
Anyone can participate, and the routes are listed
The section sets out how a person outside the agency takes part, and the list is broader than most people expect.
You can provide input on guidance documents FDA is developing. You can suggest areas for guidance development, and the regulation says your suggestion should address why a guidance document is necessary.
You can submit a draft of a proposed guidance document for FDA to consider. The regulation says to mark it Guidance Document Submission and send it to the Dockets Management Staff, and it names Docket No. FDA-2013-S-0610 for submitting one electronically through the federal rulemaking portal. Only one copy is necessary.
You can, at any time, suggest that FDA revise or withdraw an existing guidance document. The suggestion should address why, and if applicable how it should be revised.
There is an annual opening as well. Once a year FDA publishes, both in the Federal Register and on the internet, a list of possible topics for guidance development or revision during the next year, and you can comment on that list.
And the general rule sits underneath all of it. You can comment on any guidance document at any time, and FDA will revise guidance documents in response to comments when appropriate.
The provision that stops policy arriving sideways
One paragraph exists to close a loophole, and it is short enough to read in full meaning.
Start with the document types the definition excludes. The agency may not use those documents, or other means of communication, to informally communicate new or different regulatory expectations to a broad public audience for the first time.
The regulation then states when the practices apply. They must be followed whenever regulatory expectations that are not readily apparent from the statute or regulations are first communicated to a broad public audience.
Put plainly, a speech, a press release or a journal article is not supposed to be the first place a new expectation shows up. If an expectation is new and not obvious from the law, it is supposed to arrive as a guidance document, through the process the section describes.
When someone treats a guidance as a rule
The section ends with a complaint route, which is unusual and tells you the problem is a known one.
Suppose you believe someone at FDA did not follow these procedures, or treated a guidance document as a binding requirement. The regulation tells you to contact that person's supervisor in the issuing center or office.
If the issue cannot be resolved there, you contact the next highest supervisor. You can also contact the center or office ombudsman for assistance.
And if that does not work, the regulation names a last stop: you may ask the Office of the Chief Mediator and Ombudsman to become involved.
The agency also commits to upkeep. It will periodically review existing guidance documents to determine whether they need to be changed or withdrawn, and will review and, if appropriate, revise guidances when significant changes are made to the statute or regulations.
How to read a company that cites FDA guidance
Start by checking what is being claimed. A guidance can support a statement that FDA has published a recommendation. It cannot support a statement that something is required, approved or endorsed.
Look for the word draft. A draft guidance is explicitly labeled as one, and it represents thinking that has been put out for comment rather than settled.
Look for the date of issuance and any note that the document revises an earlier one. Both are required elements, and both tell you whether you are reading current thinking.
Watch for mandatory verbs. Where a guidance uses must or required, the regulation says FDA should be describing a statutory or regulatory requirement, so the citation to look for is the underlying rule rather than the guidance.
And separate the two claims that get merged. Following a guidance is one thing. Whether the law permits an alternative is a different question, and the regulation says an alternative approach is available where it complies with the relevant statutes and regulations.
What this does not cover
Everything above describes the rule that governs guidance documents as a category.
No individual guidance document is examined here, and nothing here says whether any particular guidance follows the procedure the regulation lays out.
The address and docket number for submitting a proposed guidance appear because the regulation prints them. They were not confirmed against any separate agency page, so treat them as what the regulation states rather than as a checked mailing detail.
Sources
- 21 CFR 10.115 — Good guidance practicesParagraph (a) for good guidance practices being FDA's policies and procedures for developing, issuing and using guidance documents. Paragraph (b)(1) for guidance documents being prepared for FDA staff, applicants and sponsors, and the public, and describing the agency's interpretation of or policy on a regulatory issue; (b)(2) for the subject areas they include, covering design, production, labeling, promotion, manufacturing and testing of regulated products, the processing, content and evaluation or approval of submissions, and inspection and enforcement policies; (b)(3) for the exclusions, which are documents relating to internal FDA procedures, agency reports, general information documents provided to consumers or health professionals, speeches, journal articles and editorials, media interviews, press materials, warning letters, memoranda of understanding, and other communications directed to individual persons or firms. Paragraph (c)(1) for the four level 1 triggers — initial interpretations of statutory or regulatory requirements, changes in interpretation or policy of more than a minor nature, complex scientific issues, and highly controversial issues — and (c)(2) for level 2 covering existing practices or minor changes and including all guidance documents not classified as level 1. Paragraph (d)(1) for the answer that neither you nor FDA is required to follow a guidance document, that guidance documents do not establish legally enforceable rights or responsibilities, and that they do not legally bind the public or FDA; (d)(2) for the availability of an alternative approach that complies with the relevant statutes and regulations and FDA's willingness to discuss one; (d)(3) for guidances representing the agency's current thinking and FDA employees departing from them only with appropriate justification and supervisory concurrence. Paragraph (e) for the bar on using excluded documents or other means of communication to informally communicate new or different regulatory expectations to a broad public audience for the first time, and for the statement that these practices must be followed whenever regulatory expectations not readily apparent from the statute or regulations are first communicated to a broad public audience. Paragraph (f)(1) through (f)(5) for public participation: providing input under the paragraph (g) procedures; suggesting areas for development with an explanation of why a guidance is necessary; submitting drafts of proposed guidance documents marked "Guidance Document Submission" to the Dockets Management Staff, with Docket No. FDA-2013-S-0610 named for electronic submission through the federal rulemaking portal and only one copy necessary; suggesting at any time that FDA revise or withdraw an existing guidance, addressing why and how; and the annual Federal Register and internet list of possible topics for the next year, on which the public may comment. Paragraph (g)(1) for the level 1 procedure — Federal Register notice that a draft is available, posting, and an invitation to comment, with optional public meetings or presentation to an advisory committee, followed by review of comments, a final version, a further Federal Register notice, posting and implementation; (g)(2) and (g)(3) for the exception where prior public participation is not feasible or appropriate, under which FDA publishes notice, posts, implements immediately and invites comment; (g)(4) for the level 2 procedure of posting, immediate implementation unless FDA indicates otherwise, and an invitation to comment; (g)(5) for commenting on any guidance document at any time and FDA revising in response when appropriate. Paragraph (i)(1) for the seven required elements — including the term guidance, identifying the issuing center or office, identifying the activity and the people to whom it applies, prominently displaying a statement of nonbinding effect, including the date of issuance, noting a revision and identifying the document replaced, and containing the word draft where applicable; (i)(2) for the bar on mandatory language such as shall, must, required or requirement unless FDA is describing a statutory or regulatory requirement. Paragraph (k)(1) and (k)(2) for periodic review of existing guidances and review and revision when significant changes are made to the statute or regulations. Paragraph (n) for FDA maintaining a current internet list of all guidance documents, adding new documents within 30 days of issuance, and publishing a comprehensive list annually in the Federal Register. Paragraph (o) for the escalation route where someone at FDA did not follow these procedures or treated a guidance document as a binding requirement — the person's supervisor, the next highest supervisor, the center or office ombudsman, and the Office of the Chief Mediator and Ombudsman. The section carries the source note 65 FR 56477, September 19, 2000, as amended at 83 FR 13416, March 29, 2018.
Frequently asked questions
Does FDA guidance have the force of law?
No, and the regulation says so in those terms. It asks whether you or FDA are required to follow a guidance document and answers: no. Guidance documents do not establish legally enforceable rights or responsibilities, and they do not legally bind the public or FDA. They describe the agency's interpretation of, or policy on, a regulatory issue.
Is a warning letter a guidance document?
No. The regulation's definition expressly excludes warning letters. The same exclusion covers internal FDA procedures, agency reports, and general information documents for consumers or health professionals. It also covers speeches, journal articles and editorials, media interviews and press materials. And it covers memoranda of understanding and other communications directed to individual persons or firms. Those are different categories of document from a guidance.
What is the difference between level 1 and level 2 guidance?
Level 1 covers documents that set forth initial interpretations of statutory or regulatory requirements, changes in interpretation or policy that are of more than a minor nature, complex scientific issues, or highly controversial issues. Level 2 is everything else: documents setting forth existing practices or minor changes, which the regulation says includes all guidance documents not classified as level 1. Level 1 documents ordinarily go through a draft and public comment before a final version; level 2 documents are posted and implemented immediately unless FDA indicates otherwise, with comment invited afterward.
Can a company do something a guidance says not to?
The regulation contemplates it. It states that you may choose to use an approach other than the one set forth in a guidance document, provided the alternative complies with the relevant statutes and regulations. It adds that FDA is willing to discuss an alternative approach to ensure it complies. FDA staff are treated differently. Although guidances do not legally bind the agency, employees may depart from them only with appropriate justification and supervisory concurrence.
Why does a guidance say should instead of must?
Because the regulation requires it. Guidance documents must not include mandatory language such as shall, must, required or requirement, unless FDA is using those words to describe a statutory or regulatory requirement. So a should is a recommendation, and a must inside a guidance is a signal that the document is pointing at an underlying statute or regulation.
How can someone outside FDA get a guidance changed?
Several ways are listed. You can suggest at any time that FDA revise or withdraw an existing guidance, addressing why and, if applicable, how. You can suggest areas for new guidance and explain why one is necessary. You can submit a draft of a proposed guidance marked Guidance Document Submission. Once a year FDA publishes a list of possible topics for the coming year and you can comment on it. And you can comment on any guidance document at any time.
What if an FDA reviewer treats a guidance as mandatory?
The regulation gives a route. Suppose someone at FDA did not follow these procedures, or treated a guidance document as a binding requirement. You contact that person's supervisor in the issuing center or office, then the next highest supervisor. You can also contact the center or office ombudsman. If the issue is still unresolved you may ask the Office of the Chief Mediator and Ombudsman to become involved.