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

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.

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

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availability of a draft guidance entitled ``Labeling Reusable Medical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 The draft guidance is intended to provide direction to the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 Submit written comments on the draft guidance to the Dockets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 A copy of the draft guidance and received comments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draft guidance entitled ``Labeling Reusable Medical Devices for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draft guidance is primarily directed to FDA personnel who are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