[Federal Register Volume 61, Number 43 (Monday, March 4, 1996)]
[Notices]
[Page 8440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4718]




  Federal Register / Vol. 61, No. 43 / Monday, March 4, 1996 / 
Notices  
=======================================================================
-----------------------------------------------------------------------

[[Page 8440]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 91N-0487]


Medical Devices; Protective Restraints; Draft 510(k) Guidance 
Document; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance document for the preparation of 
premarket notification (510(k)) submissions for protective restraints 
and wheelchair accessories intended for use as restraints. The draft 
guidance document is intended to assist manufacturers in complying with 
premarket notification requirements. Elsewhere in this issue of the 
Federal Register, FDA is publishing a final rule revoking exemptions 
for these devices from premarket notification and current good 
manufacturing practices regulations.

DATES: Written comments by June 3, 1996.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document to the Division of Small Manufacturers Assistance, 
Center for Devices and Radiological Health (HFZ-220), 1350 Piccard Dr., 
Rockville, MD 20850, 301-443-6597, or 1-800-638-2041. Send two self-
addressed adhesive labels to assist that office in processing your 
requests. Submit written comments on the 510(k) guidance document 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 A copy of the draft guidance document 
and received comments are available for public examination in the 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

FOR FURTHER INFORMATION CONTACT: James E. Dillard, Center for Devices 
and Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1287.

SUPPLEMENTARY INFORMATION: FDA is revising the classification 
regulations for protective restraints (21 CFR 880.6760) and wheelchair 
accessories intended for use as restraints (21 CFR 890.3910). In a 
final rule published elsewhere in this issue of the Federal Register, 
FDA is revoking the existing exemptions for these devices from 
premarket notification and current good manufacturing practices 
regulations. This action is being taken in response to a number of 
recent reports of deaths and serious injuries that may have been 
associated with improper supervision of restrained patients or improper 
application of protective restraints.
     Manufacturers and initial distributors of protective restraints 
and wheelchair accessories intended for use as restraints will be 
required to submit premarket notification submissions by September 3, 
1996. Therefore, FDA is announcing the availability of a draft guidance 
document for the preparation and submission of 510(k) submissions for 
these devices. This draft guidance will be used by FDA reviewers to 
assist in evaluating 510(k) submissions. Characteristics that 
manufacturers should address in their 510(k) submissions for restraints 
include the following: (1) Specific intended use of the device; (2) 
ease of release of the device in the event of emergencies; (3) tear 
strength of the materials; (4) potential for injury (e.g., whether 
there are abrasive materials, such as metal fasteners, that would come 
in contact with the patient's skin, and similar considerations); (5) 
ease of identification of size; (6) completeness, conspicuousness, and 
simplicity of directions and labeling; (7) care/cleaning instructions; 
(8) whether the material is biocompatible; (9) any safety testing data 
available for the device, including an analysis of bench simulation 
testing data; and for certain circumstances, (10) patient testing data. 
The draft guidance document contains more detailed information on 
restraint premarket submission requirements and should be useful to 
manufacturers during 510(k) preparation. The draft guidance document 
may be obtained from the Division of Small Manufacturers Assistance 
(address above). Manufacturers may contact the reviewing division to 
discuss the appropriate contents of their submissions on a case-by-case 
basis.
    Guidance documents do not create or confer any rights for or on any 
person and do not operate to bind FDA or others; however, they do 
represent the agency's current thinking on the subjects of the guidance 
documents. Interested persons may, on or before June 3, 1996, submit to 
the Dockets Management Branch (address above) written comments on the 
510(k) guidance document. 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. A copy of the guidance document and received comments 
may be seen in the office above between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: February 15, 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 96-4718 Filed 3-1-96; 8:45 am]
BILLING CODE 4160-01-F