Code of Federal Regulations; Technical Amendments

AGENCY:

Food and Drug Administration, HHS.

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.

DATES:

This rule is effective July 14, 2000.

FOR FURTHER INFORMATION CONTACT:

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:

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

21 CFR Part 821

• Imports
• Medical devices
• Reporting and recordkeeping requirements

21 CFR Part 895

• Administrative practice and procedure
• Labeling
• Medical devices

21 CFR Part 900

• Electronic products

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

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.

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

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

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

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

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.

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”.