Immunology and Microbiology Devices; Revocation of the Exemption From Premarket Notification; Blood Culturing System Devices; Change of Compliance Date
fda-device · Food and Drug Administration · Rule · Published 1995-10-27 · Effective 1995-10-25 · 60 FR 54942
Document
Document number
95-26678
Federal Register citation
60 FR 54942
CFR reference
21 CFR 886
Type
Rule
Action
Final rule; change of compliance date for certain manufacturers and distributors.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
1995-10-27
Effective date
1995-10-25
HHS docket
Docket No. 91N-0063
Abstract
The Food and Drug Administration (FDA) is changing the compliance date of the final rule published on July 27, 1995 (60 FR 38480), that revoked the exemption from the requirement of premarket notification for blood culturing system devices to allow a 60-day grace period for submission of premarket notifications and to change the April 22, 1996, deadline to a December 26, 1996, deadline for obtaining premarket clearance for manufacturers or initial distributors of the device that have already begun commercial distribution under the existing premarket notification exemption. This action is being taken in response to a request to reconsider the procedural requirements of the final rule.