---
kind: "section"
citation: "21 C.F.R. § 16.1"
title: "21"
number: "16.1"
heading: "Scope."
url: "https://uscodex.org/cfr/21/16.1"
---

# §16.1. Scope.


The procedures in this part apply when:

- (a) The Commissioner is considering any regulatory action, including a refusal to act, and concludes, as a matter of discretion, on the Commissioner's initiative or at the suggestion of any person, to offer an opportunity for a regulatory hearing to obtain additional information before making a decision or taking action.
- (b) The act or a regulation provides a person with an opportunity for a hearing on a regulatory action, including proposed action, and the act or a regulation either specifically provides an opportunity for a regulatory hearing under this part or provides an opportunity for a hearing for which no procedures are specified by regulation. Listed below are the statutory and regulatory provisions under which regulatory hearings are available:
  - (1) **Statutory provisions—** [Section 304(g)](/cfr/21/304.md?p=g) of the act relating to the administrative detention of devices and drugs (see §§ [800.55(g)](/cfr/21/800.55.md?p=g) and [1.980(g)](/cfr/21/1.980.md?p=g) of this chapter).

    [Section 304(h)](/cfr/21/304.md?p=h) of the act relating to the administrative detention of food for human or animal consumption (see [part 1](/cfr/21/part1.md), subpart k of this chapter).

    [Section 419(c)(2)(D)](/cfr/21/419.md?p=c-2-D) of the Federal Food, Drug, and Cosmetic Act relating to the modification or revocation of a variance from the requirements of [section 419](/cfr/21/419.md) (see [part 112](/cfr/21/part112.md), [subpart P](/cfr/21/subpartP.md) of this chapter).

    [Section 515(e)(1)](/cfr/21/515.md?p=e-1) of the act relating to the proposed withdrawal of approval of a device premarket approval application.

    [Section 515(e)(3)](/cfr/21/515.md?p=e-3) of the act relating to the temporary suspension of approval of a premarket approval application.

    [Section 515(f)(6)](/cfr/21/515.md?p=f-6) of the act relating to a proposed order revoking a device product development protocol or declaring a protocol not completed.

    [Section 515(f)(7)](/cfr/21/515.md?p=f-7) of the act relating to revocation of a notice of completion of a product development protocol.

    [Section 516(b)](/cfr/21/516.md?p=b) of the act regarding a proposed regulation to ban a medical device with a special effective date.

    [Section 518(b)](/cfr/21/518.md?p=b) of the act relating to a determination that a device is subject to a repair, replacement, or refund order or that a correction plan, or revised correction plan, submitted by a manufacturer, importer, or distributor is inadequate.

    [Section 518(e)](/cfr/21/518.md?p=e) of the act relating to a cease distribution and notification order or mandatory recall order concerning a medical device for human use.

    [Section 520(f)(2)(D)](/cfr/21/520.md?p=f-2-D) of the act relating to exemptions or variances from device current good manufacturing practice requirements (see [§ 820.1(d)](/cfr/21/820.1.md?p=d)).

    Section [520(g)(4)](/cfr/21/520.md?p=g-4) and [(g)(5)](/cfr/21/520.md?p=g-5) of the act relating to disapproval and withdrawal of approval of an application from an investigational device exemption (see §§ [812.19(c)](/cfr/21/812.19.md?p=c), [812.30(c)](/cfr/21/812.30.md?p=c), [813.30(d)](/cfr/21/813.30.md?p=d), and [813.35(c)](/cfr/21/813.35.md?p=c) of this chapter).

    [Section 903(a)(8)(B)(ii)](/cfr/21/903.md?p=a-8-B-ii) of the Federal Food, Drug, and Cosmetic Act relating to the misbranding of tobacco products.

    [Section 906(e)(1)(B)](/cfr/21/906.md?p=e-1-B) of the Federal Food, Drug, and Cosmetic Act relating to the establishment of good manufacturing practice requirements for tobacco products.

    [Section 910(d)(1)](/cfr/21/910.md?p=d-1) of the Federal Food, Drug, and Cosmetic Act relating to the withdrawal of an order allowing a new tobacco product to be introduced or delivered for introduction into interstate commerce.

    [Section 911(j)](/cfr/21/911.md?p=j) of the Federal Food, Drug, and Cosmetic Act relating to the withdrawal of an order allowing a modified risk tobacco product to be introduced or delivered for introduction into interstate commerce.

  - (2) **The regulatory provisions are as follows—**

## Notes

### Amendments

[44 FR 22367, Apr. 13, 1979]

### Authority

Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.

### Source

Source: 44 FR 22367, Apr. 13, 1979, unless otherwise noted.

### Amendments

[44 FR 22367, Apr. 13, 1979]