21 C.F.R. § 807.85

Exemption from premarket notification

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(a) A custom device is exempt from premarket notification requirements of this subpart if the device is within the meaning of section 520(b) of the Federal Food, Drug, and Cosmetic Act.

(1) It is intended for use by a patient named in the order of the physician or dentist (or other specially qualified person); or

(2) It is intended solely for use by a physician or dentist (or other specially qualified person) and is not generally available to, or generally used by, other physicians or dentists (or other specially qualified persons).

(b) A distributor who places a device into commercial distribution for the first time under his own name and a repackager who places his own name on a device and does not change any other labeling or otherwise affect the device shall be exempted from the premarket notification requirements of this subpart if:

(1) The device was in commercial distribution before May 28, 1976; or

(2) A premarket notification submission was filed by another person.

[42 FR 42526, Aug. 23, 1977, as amended at 81 FR 70340, Oct. 12, 2016]

Notes of Decisions

Cited in 3 cases, 1985–1998 · leading case: United States v. an Article of Device Consisting of 1,217 Cardboard Boxes, 607 F. Supp. 990 (W.D. Mich. 1985).

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United States v. an Article of Device Consisting of 1,217 Cardboard Boxes, 607 F. Supp. 990 (W.D. Mich. 1985). · cites it 2× “21 C.F.R. § 807.85 details the exemptions from premarket notification.”

Clinical Reference Lab'y, Inc. v. Sullivan, 791 F. Supp. 1499 (D. Kan. 1992). “In addition, the exemption from premarket notification given to “a repackager who places his own name on a device and does not change any other labeling or otherwise affect the device,” provided by 21 C.F.R. § 807.85 (b), is inapplicable because CRL changed the labeling and…”

Baker v. Danek Med., 35 F. Supp. 2d 865 (N.D. Fla. 1998). “§§ 360 (c)(2)(C), 360c(f)(l); 21 C.F.R. § 807.85 (b)(1). Second, a device may be introduced into commerce without pre-market approval if the FDA reclassifies it as a Class I or II device.”

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