CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR821.2]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 821 -- MEDICAL DEVICE TRACKING REQUIREMENTS

Subpart A - General Provisions

Sec. 821.2 Exemptions and variances.

(a) A manufacturer, importer, or distributor may seek an exemption or variance from one or more requirements of this part.

(b) A request for an exemption or variance shall be submitted in the form of a petition under § 10.30 of this chapter and shall comply with the requirements set out therein, except that a response shall be issued in 90 days. The Director or Deputy Directors, CDRH, or the Director or Principal Deputy Director of the Office of Product Evaluation and Quality, CDRH, shall issue responses to requests under this section. The petition shall also contain the following:

(1) The name of the device and device class and representative labeling showing the intended use(s) of the device;

(2) The reasons that compliance with the tracking requirements of this part is unnecessary;

(3) A complete description of alternative steps that are available, or that the petitioner has already taken, to ensure that an effective tracking system is in place; and

(4) Other information justifying the exemption or variance.

(c) An exemption or variance is not effective until the Director or Deputy Directors, CDRH, or the Director or Principal Deputy Director of the Office of Product Evaluation and Quality, CDRH, approves the request under § 10.30(e)(2)(i) of this chapter.

[58 FR 43447, Aug. 16, 1993, as amended at 59 FR 31138, June 17, 1994; 67 FR 5951, Feb. 8, 2002; 72 FR 17399, Apr. 9, 2007; 85 FR 18443, Apr. 2, 2020; 86 FR 17065, Apr. 1, 2021]