21 CFR 821.2 - Exemptions and variances.

§ 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, Office of Compliance, 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, Office of Compliance, 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]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code

Title 21 published on 10-May-2017 03:43

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 821 after this date.

  • 2013-09-24; vol. 78 # 185 - Tuesday, September 24, 2013
    1. 78 FR 58786 - Unique Device Identification System
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective December 23, 2013, except §§ 801.55, 830.10, 830.100, 830.110, 830.120, and 830.130 are effective October 24, 2013. The incorporation by reference of § 830.20 listed in the rule is approved by the Director of the Office of the Federal Register as of December 23, 2013. The incorporation by reference of §§ 830.10 and 830.100 listed in the rule is approved by the Director of the Office of the Federal Register as of October 24, 2013. Certain provisions have later compliance dates as discussed in section VII. B. “Compliance Dates.”
      21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830