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Code · CFR · Title 21 — Food and Drugs · Part 808 — Exemptions from Federal Preemption of State and Local Medical Device Requirements · § 808.25

§ 808.25. Procedures for processing an application.

642 words·~3 min read·/us/cfr/t21/s§ 808.25·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

(a)Upon receipt of an application for an exemption from preemption submitted in accordance with § 808.20, the Commissioner shall notify the State or political subdivision of the date of such receipt.
(b)If the Commissioner finds that an application does not meet the requirements of § 808.20, he shall notify the State or political subdivision of the deficiencies in the application and of the opportunity to correct such deficiencies. A deficient application may be corrected at any time.
(c)After receipt of an application meeting the requirements of § 808.20, the Commissioner shall review such application and determine whether to grant or deny an exemption from preemption for each requirement which is the subject of the application. The Commissioner shall then issue in the Federal Register a proposed regulation either to grant or to deny an exemption from preemption. The Commissioner shall also issue in the Federal Register a notice of opportunity to request an oral hearing before the Commissioner or the Commissioner's designee.
(d)A request for an oral hearing may be made by the State or political subdivision or any other interested person. Such request shall be submitted to the Dockets Management Staff within the period of time prescribed in the notice and shall include an explanation of why an oral hearing, rather than submission of written comments only, is essential to the presentation of views on the application for exemption from preemption and the proposed regulation.
(e)If a timely request for an oral hearing is made, the Commissioner shall review such a request and may grant a legislative-type informal oral hearing pursuant to part 15 of this chapter by publishing in the Federal Register a notice of the hearing in accordance with § 15.20 of this chapter. The scope of the oral hearing shall be limited to matters relevant to the application for exemption from preemption and the proposed regulation. Oral or written presentations at the oral hearing which are not relevant to the application shall be excluded from the administrative record of the hearing.
(f)If a request for hearing is not timely made or a notice of appearance is not filed pursuant to § 15.21 of this chapter, the Commissioner shall consider all written comments submitted and publish a final rule in accordance with paragraph
(g)of this section. (g)(1) The Commissioner shall review all written comments submitted on the proposed rule and the administrative record of the oral hearing, if an oral hearing has been granted, and shall publish in the Federal Register a final rule in subpart C of this part identifying any requirement in the application for which exemption from preemption is granted, or conditionally granted, and any requirement in the application for which exemption from preemption is not granted.
(2)The Commissioner may issue a regulation granting or conditionally granting an application for an exemption from preemption for any requirement if the Commissioner makes either of the following findings:
(i)The requirement is more stringent than a requirement applicable to the device under the Federal Food, Drug, and Cosmetic Act;
(ii)The requirement is required by compelling local conditions, and compliance with the requirement would not cause the device to be in violation of any requirement applicable to the device under the Federal Food, Drug, and Cosmetic Act.
(3)The Commissioner may not grant an application for an exemption from preemption for any requirement with respect to a device if the Commissioner determines that the granting of an exemption would not be in the best interest of public health, taking into account the potential burden on interstate commerce.
(h)An advisory opinion pursuant to § 808.5 or a regulation pursuant to paragraph
(g)of this section constitutes final agency action. [43 FR 18665, May 2, 1978, as amended at 87 FR 50761, Aug. 17, 2022; 88 FR 45067, July 14, 2023]
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§ 808.25
Procedures for processing an application.
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