[Federal Register Volume 59, Number 198 (Friday, October 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-25442]


[[Page Unknown]]

[Federal Register: October 14, 1994]


-----------------------------------------------------------------------


DEPARTMENT OF HEALTH AND HUMAN SERVICES
 21 CFR Part 812

[Docket No. 85N-0331]

 

Cardiovascular Devices; Notice of Agency Decision Not To Enforce 
Requirement of Premarket Approval; Replacement Heart Valve Allografts

AGENCY: Food and Drug Administration, HHS.

ACTION:  Recision of notice of applicability of a final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that it 
will no longer enforce the premarket approval requirement for 
replacement heart valve allografts. Upon publication of this document, 
these devices may be commercially distributed without an approved 
premarket approval application (PMA) and without an approved 
investigational device exemption (IDE). The agency intends to initiate 
procedures for the purpose of placing these devices into class II. FDA 
is taking this action because it believes that special controls may be 
more appropriate than premarket approval to ensure the safety and 
effectiveness of heart valve allografts. This document also confirms 
that heart valve allografts, and the processors and distributors of 
these devices, are still subject to the general controls applicable to 
all medical devices.

EFFECTIVE DATE: October 14, 1994.
FOR FURTHER INFORMATION CONTACT: Kenneth A. Palmer, Center for Devices 
and Radiological Health (HFZ-410), Food and Drug Administration, 1390 
Piccard Dr., Rockville, MD 20850, 301-594-1346.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 26, 1991 (56 
FR 29177), FDA issued a notice of applicability of a final rule to 
clarify that replacement heart valve allografts were covered by the 
regulations classifying replacement heart valves into class III (45 FR 
7904, February 5, 1980) and imposing on them the requirement of 
premarket approval (52 FR 18162, May 13, 1987).
    Recently, FDA has focused on its overall program for regulating 
articles derived from human tissue. In the Federal Register of December 
14, 1993 (58 FR 65514), the agency issued an interim rule to impose 
industry-wide standards for donor screening and recordkeeping that are 
applicable to human tissue intended for transplantation. In an effort 
to reexamine the regulatory treatment of heart valve allografts in 
light of the requirements in the interim rule and current information 
on heart valve allografts, the agency is modifying its approach to 
heart valve allografts. Therefore, the agency is rescinding the June 
26, 1991, Federal Register document.
    Effective on October 14, 1994, neither an approved application for 
premarket approval nor an investigational device exemption is required 
for commercial distribution of replacement heart valve allografts. 
Processors and distributors who had not marketed heart valve allografts 
before June 26, 1991, may commercially distribute these devices only 
upon issuance of an order by the agency under 21 U.S.C. 360c(i).
    The agency will continue to regulate heart valve allografts as 
medical devices. However, rather than continuing to require 
individualized premarket approval applications (or IDE's) for these 
devices, the agency intends to initiate procedures for the purpose of 
classifying these devices into class II, within the meaning of 21 
U.S.C. 360c(a)(1)(B), with the simultaneous development of appropriate 
special controls. Based on its increased experience with the use of 
special controls and with relevant industry-wide standards, the agency 
now believes that special controls may be adequately address the 
critical public health concerns raised by these life-sustaining 
devices.
    Although no longer subject to the class III requirement of 
premarket approval, heart valve allografts remain subject to all other 
requirements applicable to medical devices under the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 321 et seq.) and the 
regulations thereunder. Thus, the devices, and processors and 
distributors of the devices, are subject to the general controls 
identified in section 513(a)(1)(A) of the act (21 U.S.C. 
360c(a)(1)(A)), including the requirements of premarket notification 
and good manufacturing practices. In addition, the agency may inspect 
any facility in which these devices are manufactured, processed, 
packed, or held, in accordance with its authority under section 704 of 
the act (21 U.S.C. 374).
    As announced in the notice of applicability of a final rule, FDA 
has determined that allografts marketed as of the date of that notice, 
June 26, 1991, are substantially equivalent to preamendment replacement 
heart valves as defined in 21 CFR 870.3925.
    Therefore, in complying with general controls, tissue banks and 
other processors who had marketed heart valve allografts before June 
26, 1991, are not required to submit premarket notification submissions 
to the agency in accordance with 21 U.S.C. 360(k).
    In a future issue of the Federal Register, the agency will announce 
a meeting of the Circulatory Systems Device Panel to review the 
existing information on heart valve allografts and make a 
recommendation to the agency as to whether it believes that special 
controls are sufficient to provide reasonable assurance of the safety 
and effectiveness of these devices.
    This document is issued under the authority of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321 et seq).

    Dated: October 7, 1994.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 94-25442 Filed 10-13-94; 8:45 am]
BILLING CODE 4160-01-F