Description
FDA is announcing the availability of a final guidance for industry entitled “Conducting Remote Regulatory Assessments--Questions and Answers.” The final guidance makes further revisions to and replaces the revised draft guidance entitled “Conducting Remote Regulatory Assessments--Questions and Answers; Draft Guidance for Industry,” which was announced in the Federal Register on January 26, 2024 (89 FR 5244). FDA issued the revised draft guidance to describe the Agency’s thinking regarding its use of Remote Regulatory Assessments (RRAs), to help increase the industry’s understanding of voluntary and mandatory RRAs, and to facilitate FDA’s process for conducting remote assessments for FDA-regulated products outside of the COVID-19 public health emergency. The revised draft guidance reflected consideration of comments on a preceding draft guidance of the same title as well as revisions to align with 2022 changes in law (the Food and Drug Omnibus Reform Act of 2022 (FDORA)), including to address a requirement to issue guidance related to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (i.e., requests for records in advance of or in lieu of an inspection; such requests are a type of RRA). The final guidance additionally reflects consideration of comments from interested parties on the revised draft guidance.
Scope & Applicability
Product Classes
2Defined in section 201(g) of the FD&C Act; Articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease; Product classification based on chemical action or specific intended uses like altering pH
Defined in section 201(h) of the FD&C Act; Instrument or apparatus which does not achieve primary purpose through chemical action; Product classification based on primary intended purpose and chemical action
Stakeholders
5Must comply with registration if meeting facility/responsible person definitions
Establishments whose size and resources are considered in RRA timeframes.
Importers subject to Foreign Supplier Verification Program requirements.
Entities making donor eligibility determinations
The entity responsible for developing and implementing an FSVP.; entity responsible for foreign supplier verification
Regulatory Context
Attributes
2Factors used to determine whether to initiate or request an RRA.
Used to determine the priority of establishments for inspection.
Related CFR Sections (6)
- 21CFR10.20§ 10.20 Submission of documents to Dockets Management Staff; computation of time; availability for public disclosure.
(a) A submission to the Dockets Management Staff of a petition, comment, objection, notice, compilation of information, or any other document is to be filed in four copies except as otherwise specifically provided in a relevant Federal Register notice or in another section of this chapter. The DockeRead full regulation →
- 21CFR1.510§ 1.510 How must I maintain records of my FSVP?
(a) General requirements for records.Read full regulation →
- 21CFR1.512§ 1.512 What FSVP may I have if I am a very small importer or I am importing certain food from certain small foreign suppliers?
(a) Eligibility. This section applies only if:Read full regulation →
- 21CFR207.1§ 207.1 What definitions and interpretations of terms apply to this part?
The definitions and interpretations of terms in sections 201 and 510 of the Federal Food, Drug, and Cosmetic Act apply to the terms used in this part, if not otherwise defined in this section. The following definitions apply to this part:Read full regulation →
- 21CFR807.3§ 807.3 Definitions.
(a) Act means the Federal Food, Drug, and Cosmetic Act.Read full regulation →
- 21CFR211.180§ 211.180 General requirements.
(a) Any production, control, or distribution record that is required to be maintained in compliance with this part and is specifically associated with a batch of a drug product shall be retained for at least 1 year after the expiration date of the batch or, in the case of certain OTC drug products lRead full regulation →
Related Warning Letters (6)
- 2023-11-21
CGMP/Finished Pharmaceuticals/Adulterated
Brenntag Great Lakes, LLC
- 2023-04-25
Foreign Supplier Verification Program (FSVP)
Five Star Trading IL, Inc.
- 2022-05-24
Foreign Supplier Verification Program (FSVP)
Allure Foods LLC
- 2022-04-19
Foreign Supplier Verification Program (FSVP)
Agroson’s LLC
- 2022-01-18
Foreign Supplier Verification Program (FSVP)
Green Food Ingredients, LLC
- 2021-06-29
CGMP/Finished Pharmaceuticals/Adulterated
Novel Laboratories, Inc. d.b.a LUPIN
See Also (8)
- Draft Guidance for Industry: New Dietary Ingredient Notification Master Files for Dietary Supplements (Status: Draft)
- CPG Sec. 100.950 International Partnership Agreements for Compliance Activities (Status: Final)
- Guidance for Industry: Pre-Petition Consultations for Food Additives and Color Additives (Status: Final)
- Guidance for Industry and FDA Staff: Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Status: Final)
- Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use (Status: Final)
- French Translation of Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry (Questions et Réponses relatives au Registre des aliments à signaler) (Status: Final)
- Small Entity Compliance Guide: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Transportation, and Storage (Status: Final)
- Orientación preliminar de la industria: Preguntas y respuestas sobre el Registro de productos sanitarios en productos agroalimentarios, según establecido por la Ley de Enmiendas a la Alimentación y Medicamentos (FDA), 2007 (Edición 2) (Status: Draft)