The procedures in this part apply when:
Table 1 to Paragraph (b)(1)
Section 304(g) of the Federal Food, Drug, and Cosmetic Act relating to the administrative detention of devices and drugs (see §§ 800.55(g) and 1.980(g) of this chapter). |
Section 304(h) of the Federal Food, Drug, and Cosmetic Act relating to the administrative detention of food for human or animal consumption (see part 1, subpart k of this chapter). |
Section 419(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 (see part 112, subpart P of this chapter). |
Section 515(e)(1) of the Federal Food, Drug, and Cosmetic Act relating to the proposed withdrawal of approval of a device premarket approval application. |
Section 515(e)(3) of the Federal Food, Drug, and Cosmetic Act relating to the temporary suspension of approval of a premarket approval application. |
Section 515(f)(6) of the Federal Food, Drug, and Cosmetic Act relating to a proposed order revoking a device product development protocol or declaring a protocol not completed. |
Section 515(f)(7) of the Federal Food, Drug, and Cosmetic Act relating to revocation of a notice of completion of a product development protocol. |
Section 516(b) of the Federal Food, Drug, and Cosmetic Act regarding a proposed regulation to ban a medical device with a special effective date. |
Section 518(b) of the Federal Food, Drug, and Cosmetic 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) of the Federal Food, Drug, and Cosmetic 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) of the Federal Food, Drug, and Cosmetic Act relating to exemptions or variances from device current good manufacturing practice requirements (see § 820.1(d) ). |
Section 520(g)(4) and (g)(5) of the Federal Food, Drug, and Cosmetic Act relating to disapproval and withdrawal of approval of an application from an investigational device exemption (see §§ 812.19(c) , 812.30(c) , 813.30(d), and 813.35(c) of this chapter). |
Section 903(a)(8)(B)(ii) of the Federal Food, Drug, and Cosmetic Act relating to the misbranding of tobacco products. |
Section 906(e)(2)(E) of the Federal Food, Drug, and Cosmetic Act relating to exemptions or variances from tobacco product manufacturing practice requirements. |
Section 910(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) 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. |
Table 2 to paragraph (b)(2)
Sections 1.634 and 1.664 , relating to revocation of recognition of an accreditation body and withdrawal of accreditation of third-party certification bodies that conduct food safety audits of eligible entities in the food import supply chain and issue food and facility certifications. |
Section 1.1173 , relating to the revocation of recognition of an accreditation body, and the disqualification of a laboratory, with respect to food testing conducted under part 1, subpart R of this chapter. |
Section 1.1174 , relating to the issuance of a directed food laboratory order by FDA pursuant to § 1.1108 . |
Section 56.121(a) , relating to disqualifying an institutional review board or an institution. |
Section 58.204(b) , relating to disqualifying a testing facility. |
Section 71.37(a) , relating to use of food containing a color additive. |
Section 80.31(b) , relating to refusal to certify a batch of a color additive. |
Section 80.34(b) , relating to suspension of certification service for a color additive. |
Section 99.401(c) , relating to a due diligence determination concerning the conduct of studies necessary for a supplemental application for a new use of a drug or device. |
Sections 112.201 through 112.213 , (see part 112, subpart R of this chapter), relating to withdrawal of a qualified exemption. |
Sections 117.251 through 117.287 (part 117, subpart E of this chapter), relating to withdrawal of a qualified facility exemption. |
Section 130.17(1) , relating to a temporary permit to vary from a food standard. |
Section 170.17(b) , relating to use of food containing an investigational food additive. |
Section 202.1(j)(5) , relating to approval of prescription drug advertisements. |
Section 230.150(b), relating to revocation of the grant of a certification for a designated medical gas. |
Section 312.70 , relating to whether an investigator is eligible to receive test articles under part 312 of this chapter and eligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA, including drugs, biologics, devices, new animal drugs, foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, and tobacco products. |
Sections 312.70(d) and 312.44 , relating to termination of an IND for a sponsor. |
Section 312.160(b) , relating to termination of an IND for tests in vitro and in laboratory research animals for a sponsor. |
Section 507.60 through 507.85 (part 507, subpart D of this chapter) relating to withdrawal of a qualified facility exemption. |
Section 511.1(b)(5) , relating to use of food containing an investigational new animal drug. |
Section 511.1(c)(1) , relating to whether an investigator is eligible to receive test articles under part 511 of this chapter and eligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA including drugs, biologics, devices, new animal drugs, foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, and tobacco products; and any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug. |
Section 511.1(c)(4) and (d) , relating to termination of an INAD for a sponsor. |
Section 812.119 , relating to whether an investigator is eligible to receive test articles under part 812 of this chapter and eligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA including drugs, biologics, devices, new animal drugs, foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, and tobacco products. |
Section 814.46(c) relating to withdrawal of approval of a device premarket approval application. |
Section 822.7(a)(3) , relating to an order to conduct postmarket surveillance of a medical device under section 522 of the act. |
Section 830.130 , relating to suspension or revocation of the accreditation of an issuing agency. |
Section 895.30(c) , regarding a proposed regulation to ban a medical device with a special effective date. |
Section 900.7 , relating to approval, reapproval, or withdrawal of approval of mammography accreditation bodies or rejection of a proposed fee for accreditation. |
Section 900.14 , relating to suspension or revocation of a mammography certificate. |
Section 900.25 , relating to approval or withdrawal of approval of certification agencies. |
Section 1003.11(a)(3) , relating to the failure of an electronic product to comply with an applicable standard or to a defect in an electronic product. |
Section 1003.31(d) , relating to denial of an exemption from notification requirements for an electronic product which fails to comply with an applicable standard or has a defect. |
Section 1004.6 , relating to plan for repurchase, repair, or replacement of an electronic product. |
Section 1107.1(d) , relating to rescission of an exemption from the requirement of demonstrating substantial equivalence for a tobacco product. |
Section 1107.50 , relating to rescission of an order finding a tobacco product substantially equivalent. |
Section 1210.30 , relating to denial, suspension, or revocation of a permit under the Federal Import Milk Act. |
Section 1270.43(e), relating to the retention, recall, and destruction of human tissue. |
Section 1271.440(e) relating to the retention, recall, and destruction of human cells, tissues, and cellular and tissue-based products (HCT/Ps), and/or the cessation of manufacturing HCT/Ps. |
21 C.F.R. §16.1
For FEDERAL REGISTER citations affecting § 16.1 , see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.