[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availability of a draft guidance entitled ``Labeling Reusable Medical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 The draft guidance is intended to provide direction to the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ADDRESSES: Submit written requests for single copies of the draft
guidance entitled ``Labeling Reusable Medical Devices for Reprocessing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 Submit written comments on the draft guidance to the Dockets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 A copy of the draft guidance and received comments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draft guidance entitled ``Labeling Reusable Medical Devices for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draft guidance is primarily directed to FDA personnel who are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
