[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
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[[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.
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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availability of a draft guidance document for the preparation of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 The draft
guidance document is intended to assist manufacturers in complying with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ADDRESSES: Submit written requests for single copies of the draft
guidance document to the Division of Small Manufacturers Assistance,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 A copy of the draft guidance document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
