[Federal Register Volume 60, Number 115 (Thursday, June 15, 1995)]
[Notices]
[Page 31484]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-14588]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95D-0148]


Guidance for Labeling Reusable Medical Devices for Reprocessing 
in Health Care Facilities; Draft; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance entitled ``Labeling Reusable Medical 
Devices for Reprocessing in Health Care Facilities: FDA Reviewer 
Guidance.'' The draft guidance is intended to provide direction to the 
agency's personnel who are responsible for premarket evaluation of 
medical devices and to provide criteria for the labeling instructions 
for reprocessing reusable devices.

DATES: Written comments by August 14, 1995.

ADDRESSES: Submit written requests for single copies of the draft 
guidance entitled ``Labeling Reusable Medical Devices for Reprocessing 
in Health Care Facilities: FDA Reviewer Guidance'' to the Division of 
Small Manufacturers Assistance, Center for Devices and Radiological 
Health (HFZ-220), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-443-0806 (outside MD 1-800-638-2041). Send two 
self-addressed adhesive labels to assist that office in processing your 
requests. Submit written comments on the draft guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857. Requests and comments should 
be identified with the docket number found in brackets in the heading 
of this document. A copy of the draft guidance and received comments 
are available for public examination in the Dockets Management Branch 
(address above) between 9 a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Chiu S. Lin, Center for Devices and 
Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-443-8913.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
draft guidance entitled ``Labeling Reusable Medical Devices for 
Reprocessing in Health Care Facilities: FDA Reviewer Guidance.'' The 
draft guidance is primarily directed to FDA personnel who are 
responsible for the evaluation of premarket notification submissions 
(510(k)'s) and premarket approval (PMA) applications. The draft 
guidance will also assist persons preparing 510(k)'s and PMA's for 
submission to FDA.
    Under the Federal Food, Drug, and Cosmetic Act, and FDA labeling 
regulations (21 CFR 801.5), a device is required to bear adequate 
directions for use. In reprocessing a reusable device (e.g., clean, 
disinfect, or sterilize), adequate instructions are important in 
preparing the device for the next patient. The draft guidance provides 
criteria for the labeling instructions on reprocessing reusable medical 
devices. The criteria are also applicable to initial processing of 
single use only and reusable devices that are supplied nonsterile, and 
reprocessing of certain sterile, single use only implantable devices if 
they become contaminated before implantation (e.g., orthopedic 
implants).
    The document does not provide in-depth guidance on design and 
testing factors related to infection control. It is essential that the 
manufacturer consider infection control requirements during product 
design and testing to facilitate cleaning and sterilization or 
disinfection. Design and testing factors are addressed in device 
specific FDA guidance and FDA's good manufacturing practices guidance.
    FDA staff and persons preparing submissions should also refer to 
the Technical Information Report (TIR), developed by the Association 
for the Advancement of Medical Instrumentation (AAMI), entitled 
``Designing, Testing, and Labeling Reusable Medical Devices for 
Reprocessing in Health Care Facilities: A Guide for Device 
Manufacturers,'' AAMI TIR No. 12-1994. The AAMI TIR provides 
comprehensive technical information for manufacturers and user 
perspectives on this topic.
    Guidances have generally been issued under Sec. 10.90(b) (21 CFR 
10.90(b)), which provides for the use of guidances to state procedures 
or standards of general applicability that are not legal requirements 
but that are acceptable to FDA. The agency is now in the process of 
revising Sec. 10.90(b). Therefore, the draft guidance is not being 
issued under the authority of current Sec. 10.90(b), and it does not 
create or confer any rights, privileges, or benefits for or on any 
person, nor does it operate to bind FDA in any way.
    Interested persons may, on or before (insert date 60 days after 
date of publication in the Federal Register), submit to the Dockets 
Management Branch (address above) written comments on the draft 
guidance. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. The 
draft guidance and received comments may be seen in the Docket 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: June 6, 1995.
D.B. Burlington
Director, Center for Devices and Radiological Health.
[FR Doc. 95-14588 Filed 6-14-95; 8:45 am]
BILLING CODE 4160-01-F