21 C.F.R. § 808.5

Advisory opinions

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(a) Any State, political subdivision, or other interested person may request an advisory opinion from the Commissioner with respect to any general matter concerning preemption of State or local device requirements or with respect to whether the Food and Drug Administration regards particular State or local requirements, or proposed requirements, as preempted.

(1) Such an advisory opinion may be requested and may be granted in accordance with § 10.85 of this chapter.

(2) The Food and Drug Administration, in its discretion and after consultation with the State or political subdivision, may treat a request by a State or political subdivision for an advisory opinion as an application for exemption from preemption under § 808.20.

(b) The Commissioner may issue an advisory opinion relating to a State or local requirement on his own initiative when he makes one of the following determinations:

(1) A requirement with respect to a device for which an application for exemption from preemption has been submitted under § 808.20 is not preempted by section 521(a) of the Federal Food, Drug, and Cosmetic Act because it is: (i) Equal to or substantially identical to a requirement under the Federal Food, Drug, and Cosmetic Act applicable to the device, or (ii) is not a requirement within the meaning of section 521 of the Federal Food, Drug, and Cosmetic Act and therefore is not preempted;

(2) A proposed State or local requirement with respect to a device is not eligible for exemption from preemption because the State or local requirement has not been issued in final form. In such a case, the advisory opinion may indicate whether the proposed requirement would be preempted and, if it would be preempted, whether the Food and Drug Administration would propose to grant an exemption from preemption;

(3) Issuance of such an advisory opinion is in the public interest.

[43 FR 18665, May 2, 1978, as amended at 87 FR 50761, Aug. 17, 2022]

Notes of Decisions

Cited in 5 cases, 1994–2000 · leading case: Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).

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Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996). · cites it 2× “See 21 CFR § 808.5 (1995). The ambiguity in the statuteand the congressional grant of authority to the agency on the matter contained within itprovide a "sound basis," post, at 509 (O'Connor, J.”

Geier v. Am. Honda Motor Co., 529 U.S. 861 (2000). · cites it 2× “470, 496 (1996) (discussing 21 CFR § 808.5 (1995), an FDA regulation allowing a State to request an advisory opinion regarding whether a particular state-law requirement is pre-empted, or exempt from pre-emption, under the Medical Device Amendments of 1976).”

Haudrich v. Howmedica, Inc., 642 N.E.2d 206 (Ill. App. Ct. 1994). · cites it 2× “) ( 21 C.F.R. § 808.5 (a) (1994).) Although it might be quite helpful to a State, county, or city to have the Commissioner’s input on whether its requirement would be preempted, and therefore it might be appropriate for any or all of those entities to seek an advisory opinion…”

Mitchell v. Collagen Corp., 870 F. Supp. 885 (N.D. Ind. 1994). “” The Mitch-ells believe that until the FDA makes this determination after being requested by an “interested person” to issue an advisory opinion as to preemption pursuant to 21 C.F.R. § 808.5 (a), the MDA has no preemptive effect and a court ruling otherwise would “usurp the…”

Kramer v. Bausch & Lomb, Inc., 264 A.D.2d 596 (N.Y. App. Div. 1999). “Following denial of that motion, defendant solicited an advisory opinion from the FDA (21 CFR 808.5) as to whether defendant’s marketing practices constituted deceptive advertising.”

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