FDA Guidance Documents
Is a medical device company required to follow the recommendations of FDA guidance documents?
Federal Register - Section 5 - Legal Effect of Guidance Documents
Vol. 65, No. 182 / Tuesday, September 19, 2000 / Rules and Regulations [page] 56471
5. Legal Effect of Guidance Documents
(Comment 18)
We received several comments on the legal effect of guidance documents. A number of comments referred to the statement in the proposed regulation that we are willing to discuss an alternative approach with you to ensure that it complies with the relevant statutes and regulations (§ 10.115(c)(3)). The comments stated that if a guidance document is not binding, the discussion of alternative approaches should not be required.
The comments misinterpreted the intent of the statement in § 10.115(c)(3). If you take an alternative approach, you are not required to discuss that approach with us. Instead, we are offering our assistance to make sure that any alternative approach you take meets the appropriate statutory or regulatory requirements. Discussing alternative approaches may help you understand our interpretation of the applicable statutes and regulations and may further our understanding of the merits of your approach.
(Comment 19)
Two comments suggested that compliance with a guidance document should provide a company with a safe harbor from FDA enforcement action. The comments recommended that we change the regulation to require us to amend, or at least publish a proposal to amend, a guidance document before initiating an enforcement action against a company that acted in accordance with a guidance. The comments also noted that if we do not provide a safe harbor from enforcement, at a minimum, a company’s action in accordance with a guidance document should be evidence of the company’s intent to comply with our regulations.
Section 701(h)(1)(B) of the act provides that guidance documents ‘‘shall not be binding on the Secretary.’’ Creating a ‘‘safe harbor’’ in a guidance document that would preclude us from taking action would impermissibly bind us. In issuing enforcement-related guidance documents, we express our current thinking regarding regulatory matters and believe this provides useful information. However, you always remain independently responsible for complying with applicable statutes and regulations. Whether you have complied with the law is determined from the facts of each case.
(Comment 20)
We received two comments suggesting that we clarify to our staff that FDA may not cite failure to follow a guidance document in any observation on Form FDA 483 (List of Inspectional Observations).
We agree with this comment. Guidance documents are not binding. An enforcement action may be taken only when we find a violation of statutory or regulatory requirements. If a guidance document contains a reference to a regulatory or statutory requirement, then enforcement action may be taken if the regulation or statutory requirement is violated. Of course, enforcement action may be taken if a requirement in a regulation or statute is violated whether or not there is a reference to the requirements in any guidance document. We discuss this issue in the GGP training we provide employees under § 10.115(l)(1).
(Comment 21)
We received one comment on how we should interpret a draft guidance document during the time that it is out for comment, before the document has been finalized. The comment suggested that we maintain three categories of guidance documents: Draft, approvable, and approved.
We believe the provisions of § 10.115(g) sufficiently describe both the process for issuing draft Level 1 guidance documents for comment and the process of implementing Level 1 guidance documents without comment when prior public participation is not feasible or appropriate. We do not believe that adding more categories will improve the process; instead, it could confuse the users of the documents.
Early in the process of developing the GGP’s, comments strongly urged the agency to streamline and simplify the nomenclature for guidance documents. We have done so. If you are concerned about FDA’s thinking on an issue that is reflected only in a draft guidance, you should contact the appropriate office within FDA to discuss the issue.
While a draft Level 1 guidance document is out for comment, you may be concerned that the guidance will change based on comments received. Because a guidance document represents the agency’s current thinking on a subject but it is not ever binding on FDA or outside parties, you should not rely on any guidance document, draft or final. If you have questions about compliance with statutory or
regulatory requirements, you can discuss those issues with an FDA employee.
DISCUSSION - Federal Register Section 5
Why does the FDA say that guidance documents are non-binding?
FIRST:
Because – by law (Federal Register / Vol. 65, No. 182 page 56471) – guidance documents cannot bind or preclude the Secretary (of HHS) from taking an enforcement action, even if a company followed, or attempted to follow, a guidance document.
SECOND:
Application of the principles in the guidance document, or a company’s best attempt to interpret and apply them, may or may not be sufficient in any particular case. It is up to the company to ensure that the regulations are complied with, regardless of whether or not they are basing their actions on a guidance document.
The guidance document cannot be seen as providing a “safe harbor” from regulatory action.
Federal Register (continued) - Section 6 - FDA's rationale for offering Guidance Documents
6. Standard Elements
(Comment 23)
One comment suggested that we require as an element in each guidance document a statement that explains why the document is needed.
Guidance documents should be issued only when a need for guidance exists. In each document, we generally include a background section that states the reason for its issuance. We will continue to do this in the future. However, although we acknowledge the utility of stating the need for each guidance, we do not believe the statement should be required. The advice we provide in a guidance document represents our current thinking, regardless of whether we adequately explain the need for the guidance. Therefore, we decline to make this information a required element in our guidance documents.
(Comment 24)
One comment suggested that statements of nonbinding effect be prominently displayed on all guidance documents.
We agree with the comment. It is critical that all parties understand that guidance documents do not bind us or you. We are amending the regulation at § 10.115(i)(1)(iv) to require that a statement of the guidance document’s nonbinding effect be displayed on prominently each document. In the future, this statement will be placed immediately below the title of the guidance document on the first page of text and it will be in prominent (e.g., bold or italic) print.
(Comment 29)
One comment suggested that we publish a new guidance document within 30 days of changing our current thinking on a given subject. This comment also urged us to amend the regulations to clarify that the information in a guidance document may be relied on to be currently acceptable to FDA.
We agree that guidance documents should reflect our current thinking on a given subject. We try to ensure that our documents are current. However, we allocate our limited resources to the areas of greatest public health need. Although GGP’s help to ensure a greater level of public participation in guidance development, following these procedures often means that it takes longer to issue guidance documents. Therefore, we will not commit ourselves to issuing guidance documents within a specific timeframe. We need flexibility to allocate our resources as we see fit, for example, to an area that presents more significant public health issues.
In response to the second part of the comment, § 10.115(d)(3) of the final rule clearly states that guidance documents represent the agency’s current thinking on the subject of the document, and that FDA employees may depart from guidance documents only with appropriate justification and supervisory concurrence.
(Comment 30)
One comment stated that if we depart from a guidance document on multiple occasions, we should consider revising the document. A similar comment noted that when a change in policy allows deviation from a guidance document, we should amend the document to indicate the existence of limited exceptions.
As discussed previously, guidance documents should represent our current thinking on the matters discussed in the documents. Our consistent deviation from a guidance document might suggest that we should revise it. Furthermore, we should amend guidance documents to clarify any changes in our interpretation of a guidance document. As resources allow, we will continue to update and revise guidance documents to reflect our current thinking.
(Comment 31)
One comment suggested that we provide written justification for deviating from a guidance document.
As discussed in the preamble to the proposed rule (65 FR 7321 at 7327), we agree that our employees should not deviate from guidance without appropriate justification and supervisory concurrence. However, because guidance documents are not legally binding, we do not believe that we should provide written notice stating the reasons for such deviations. If we are asked to explain why we are deviating from a guidance document, we will do so.
(Comment 39)
One comment suggested that we examine our processes for training, evaluation, and related internal guidance to ensure that our directives to staff reinforce the appropriate use of guidance documents.
Section 701(h)(1)(B) of the act requires us to provide training for employees on how to develop and use guidance documents. We train employees about guidance documents in new employee orientation and/or as part of continuing employee education and training programs. Internal procedural documents are examined before they are issued to ensure that they are consistent with our GGP policies.
(Comment 40)
Several comments recommended that there be better internal coordination among centers in the development, issuance, and use of guidance documents. In particular, one comment suggested that FDA ensure closer communication among centers, clarify the role of each center in oversight, and communicate clearly the enforcing center’s expectation of a firm’s responsibility for following a guidance document.
DISCUSSION - Federal Register Section 6
The FDA issues guidance documents when they feel that a need exists.
FDA employees may deviate from a guidance document only with supervisory concurrence.
Federal Register (continued) - Section 10 - What is a Guidance Document, and what does "Legally Enforceable" mean?
§ 10.115 Good guidance practices.
(a) What are good guidance practices?
Good guidance practices (GGP’s) are 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.
(3) 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, press materials, warning letters, memoranda of understanding, or other communications directed to individual persons or firms.
(c) What other terms have a special meaning?
(1) ‘‘Level 1 guidance documents’’ include guidance documents that:
(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 FDA.
(d) Are you or 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 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. 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 FDA, they represent the agency’s current thinking. Therefore, FDA employees may depart from guidance documents only with appropriate justification and supervisory concurrence.
(e) Can 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 GGP’s must be followed whenever regulatory expectations that are not readily apparent from the statute or regulations are first communicated to a broad public audience.
DISCUSSION - Federal Register Section 10
Guidance documents are not binding on the FDA or the public. However …
- FDA employees are required to follow the guidance in guidance documents, and may depart from the guidance only with agency permission (appropriate justification and supervisory concurrence).
- FDA uses guidance documents to describe their interpretation of, or policy on, a regulatory issue.
- FDA uses guidance documents to communicate regulatory expectations that are not readily apparent from the statute or regulations.
- Guidance documents represent the FDA’s current thinking on an issue. (cGMP -> current GMP)
GUIDELINE ON GENERAL PRINCIPLES OF PROCESS VALIDATION (1987)
NOTE: There is another version that was issued in January 2011. As of April, 2011 it has not yet been adopted by the CDRH. The 2011 version notes that the CDRH bases much of its direction on the work of GHTF Study Group 3.
II. SCOPE
This guideline is issued under Section 10.90 (21 CFR 10.90) and is applicable to the manufacture of pharmaceuticals and medical devices. It states principles and practices of general applicability that are not legal requirements but are acceptable to the FDA. A person may rely upon this guideline with the assurance of its acceptability to FDA, or may follow different procedures. When different procedures are used, a person may, but is not required to, discuss the matter in advance with FDA to prevent the expenditure of money and effort on activities that may later be determined to be unacceptable. In short, this guideline lists principles and practices which are acceptable to the FDA for the process validation of drug products and medical devices; it does not list the principles and practices that must, in all instances, be used to comply with law.
DISCUSSION - General Principles of Process Validation
Note the comments that are either in color, that are underlined, or that are in bold.