Food and Drug Administration, HHS.
Final rule; technical amendments.
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.
This rule is effective July 14, 2000.Start Further Info
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.End Further Info End Preamble Start Supplemental 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.Start List of Subjects
List of Subjects
- Medical devices
- Reporting and recordkeeping requirements
- Administrative practice and procedure
- Medical devices
- 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:End Amendment Part Start Part
PART 821—MEDICAL DEVICE TRACKING REQUIREMENTSEnd Part Start Amendment Part
1. The authority citation for 21 CFR part 821 continues to read as follows:End Amendment Part
2. Section 821.50 Availability is amended in paragraph (a) by removing “Form FD 482” and by adding in its place “Form FDA 482”.End Amendment Part Start Part
PART 895—BANNED DEVICESEnd Part Start Amendment Part
3. The authority citation for 21 CFR part 895 continues to read as follows:End Amendment Part
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)”.End Amendment Part Start Part
PART 900—MAMMOGRAPHYEnd Part Start Amendment Part
5. The authority citation for 21 CFR part 900 continues to read as follows:End Amendment Part
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 Amendment Part Start Signature
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