Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 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.

Where this section sits in the code

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

(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.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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