[Federal Register Volume 60, Number 208 (Friday, October 27, 1995)]
[Rules and Regulations]
[Page 54942]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-26678]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 886

[Docket No. 91N-0063]


Immunology and Microbiology Devices; Revocation of the Exemption 
From Premarket Notification; Blood Culturing System Devices; Change of 
Compliance Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; change of compliance date for certain manufacturers 
and distributors.

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SUMMARY: 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.

DATES:
    Effective date: The final rule is effective October 25, 1995.
    Compliance dates: A premarket notification submission is required 
for any automated blood culturing system intended to be introduced or 
delivered for introduction into commerce on or after October 25, 1995, 
under section 510(k) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360(k)), and the procedures in subpart E of 21 CFR part 807. A 
manufacturer or an initial distributor of a blood culturing device that 
has already begun commercial distribution under the existing premarket 
notification exemption is required to submit a premarket notification 
on or before December 26, 1995, and must have a premarket notification 
cleared by FDA by December 26, 1996.
FOR FURTHER INFORMATION CONTACT: Lisa A. Rooney, Center for Devices and 
Radiological Health (HFZ-84), Food and Drug Administration, 2094 
Gaither Rd., Rockville, MD 20850, 301-594-4765, ext. 164.
SUPPLEMENTARY INFORMATION: In the Federal Register of November 9, 1982 
(47 FR 50814 at 50826), FDA published a final rule to classify blood 
culturing system devices into class I (21 CFR 866.2560). In the Federal 
Register of June 12, 1989 (54 FR 25042 at 25046), FDA published a final 
rule exempting microbial growth monitors, subject to certain 
limitations. In the Federal Register of April 26, 1991 (56 FR 19333), 
FDA proposed to revoke this exemption for blood culturing system 
devices because of safety and effectiveness considerations. In the 
proposed rule, FDA stated that a manufacturer or an initial distributor 
who has introduced blood culturing system devices into commerce since 
the premarket notification exemption became effective would be required 
to submit to FDA a premarket notification within 60 days after the 
final rule based upon the proposal became effective.
    In the Federal Register of July 27, 1995 (60 FR 38480), FDA 
published a final rule to revise the microbial growth monitor 
classification regulation by revoking the exemption from the premarket 
notification requirements for automated blood culturing system devices 
used in testing blood and other normally sterile body fluids for 
bacteria, fungi, and other microorganisms. According to the final rule, 
a manufacturer or an initial distributor of a blood culturing device 
that had already begun commercial distribution under the existing 
premarket notification exemption would be required to submit a 
premarket notification on or before October 25, 1995, and have a 
premarket notification cleared by FDA by April 22, 1996.
    In response to a letter requesting FDA to reconsider the procedural 
requirements of the final rule of July 27, 1995, FDA has decided to 
allow a 60-day grace period for submission of premarket notifications 
for manufacturers or initial distributors who have already begun 
introducing blood culturing system devices into commerce under the 
existing premarket notification exemption. However, a premarket 
notification submission is still required for any automated blood 
culturing system intended to be introduced or delivered for 
introduction into interstate commerce on or after October 25, 1995. 
Furthermore, in response to the correspondence, FDA has decided to 
change the April 22, 1996, deadline to a December 26, 1996, deadline 
for obtaining premarket clearance.

    Dated: October 23, 1995,
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-26678 Filed 10-26-95; 8:45 am]
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