What 21 CFR Part 808 - Exemptions from Federal Preemption of State and Local Medical Device Requirements (FDA Section 521 Petitions) requires
21 CFR Part 808 prescribes the procedures by which a State or political subdivision may apply to the U.S. Food and Drug Administration for an exemption from the Federal preemption of State and local requirements applicable to medical devices under section 521 of the Federal Food, Drug, and Cosmetic Act (21 USC 360k). Section 808.1 provides that the FDA Commissioner may grant an exemption only where the State requirement is more stringent than a requirement under the Federal Food, Drug, and Cosmetic Act applicable to the device, or the State requirement is required by compelling local conditions and compliance with the State requirement would not cause the device to be in violation of any applicable requirement under the Federal Food, Drug, and Cosmetic Act. Section 808.5 authorises any State or interested party to request an advisory opinion from the Commissioner on whether the FDA regards a particular State or local requirement as preempted - the Commissioner may treat the request as an application for exemption from preemption. Section 808.20 sets the application format - a letter to the Commissioner signed by an authorised State or local representative attaching the statute or regulation, the comparison with the analogous Federal requirement, the problem identification, and the basis for exemption on either greater stringency or compelling local conditions. Section 808.25 sets the review procedure - the Commissioner publishes a proposed rule in the Federal Register with notice of opportunity to request an oral hearing, considers comments and any hearing record, and publishes a final rule granting, conditionally granting, or denying the exemption. Section 808.35 sets the revocation criteria - an exemption remains effective until revoked, and may be revoked when new Federal requirements address the objective served by the exempted State requirement, when the conditions underlying the original grant change, when the State fails to meet conditions of the original grant or to submit records the Commissioner requires, when the State requests revocation, or when the Commissioner determines the exemption is no longer in the public health interest. Subpart C codifies the operative grants and denials state by state - Section 808.55 records that specific provisions of the California Sherman Food, Drug, and Cosmetic Law and the California Business and Professions Code are preempted under section 521(a) and have been denied exemption from preemption.
Pillar: Medical & Healthcare · Authority: United States Food and Drug Administration, Office of the Commissioner, implementing section 521 of the Federal Food, Drug, and Cosmetic Act as codified at 21 USC 360k, with the regulatory text published in the Code of Federal Regulations Title 21 Part 808 and maintained on a current basis by the Office of the Federal Register · Version: 1.0.0 · Last updated:
Primary source: https://www.govinfo.gov/content/pkg/CFR-2024-title21-vol8/xml/CFR-2024-title21-vol8-part808.xml
SHA-256 integrity: 4675ce9e7fb5e834d88218abe8f125b5e6f33cfd437d9b03b3ceba160cc98040
Primary Citations — 8 traced to source
- 21 CFR 808.1 - Scope - prescribes procedures for submission, review, and approval of applications for exemption from Federal preemption of State and local requirements applicable to medical devices under section 521 of the Federal Food, Drug, and Cosmetic Act; Section 808.1(d) sets the two-prong substantive standard - more stringent than a Federal Food, Drug, and Cosmetic Act requirement applicable to the device, or required by compelling local conditions without Federal violation
- 21 CFR 808.5 - Advisory opinions - authorises States, political subdivisions, and other interested parties to request an advisory opinion from the FDA Commissioner; the Commissioner may treat the request as an application for exemption from preemption
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