Skip to Content
Rule

Code of Federal Regulations; Technical Amendments

Action

Final Rule; Technical Amendments.

Summary

The Food and Drug Administration (FDA) is amending its regulations to correct some errors that have become incorporated into the regulations. This action is being taken to improve the accuracy of the regulations.

 

Table of Contents Back to Top

DATES: Back to Top

This rule is effective July 14, 2000.

FOR FURTHER INFORMATION CONTACT: Back to Top

LaJuana D. Caldwell, Office of Policy, Planning, and Legislation (HF-927), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7010.

SUPPLEMENTARY INFORMATION: Back to Top

FDA has discovered that errors have been incorporated into the agency's codified regulations for 21 CFR parts 821, 895, and 900. This document corrects those errors. Publication of this document constitutes final action under the Administrative Procedure Act (5 U.S.C. 553). FDA has determined that notice and public comment are unnecessary because this amendment is nonsubstantive.

List of Subjects Back to Top

begin regulatory text

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 821, 895, and 900 are amended as follows:

PART 821—MEDICAL DEVICE TRACKING REQUIREMENTS Back to Top

1.The authority citation for 21 CFR part 821 continues to read as follows:

Authority:

21 U.S.C. 331, 351, 352, 360, 360e, 360h, 360i, 371, 374.

§ 821.50 [Amended]

2.Section 821.50 Availability is amended in paragraph (a) by removing “Form FD 482” and by adding in its place “Form FDA 482”.

PART 895—BANNED DEVICES Back to Top

3.The authority citation for 21 CFR part 895 continues to read as follows:

Authority:

21 U.S.C. 352, 360f, 360h, 360i, 371.

§ 895.21 [Amended]

4.Section 895.21 Procedures for banning a device is amended in the fourth sentence of paragraph (d)(8) by removing “201(y)” and by adding in its place “201(x)”.

PART 900—MAMMOGRAPHY Back to Top

5.The authority citation for 21 CFR part 900 continues to read as follows:

Authority:

21 U.S.C. 360i, 360nn, 374(e); 42 U.S.C. 263b.

§ 900.12 [Amended]

6.Section 900.12 Quality standards is amended in paragraph (e)(5)(iii)(A)(1) by removing “Cycles/millimeters” and by adding in its place “Cycles/millimeter”, and in the third sentence of paragraph (f)(3) by removing “results and notifying” and by adding in its place “results and for notifying”.

end regulatory text

Dated: June 27, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00-17811 Filed 7-13-00; 8:45 am]

BILLING CODE 4160-01-F

Site Feedback