[Federal Register Volume 64, Number 195 (Friday, October 8, 1999)]
[Notices]
[Pages 54901-54902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-26220]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-4130]
Medical Devices; Draft Guidance on Information Disclosure by
Manufacturers to Assemblers for Diagnostic X-Ray Systems; 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availability of a draft guidance entitled ``Guidance on Information
Disclosure by Manufacturers to Assemblers for Diagnostic X-ray
Systems.'' This draft guidance document provides guidance to industry
on certain information about assembly, installation, adjustment, and
testing that original equipment manufacturers must disclose at cost to
users and assemblers of diagnostic x-ray equipment systems. The scope
of the disclosure requirement needs clarification due to the
development of computerized technology and inclusion in software of
specific information that some manufacturers consider proprietary. This
draft guidance explains what information must be disclosed to ensure
that diagnostic x-ray components or diagnostic x-ray systems are able
to meet applicable Federal performance standards that reduce or
maintain x-ray exposure to the patient and operator at the lowest
possible level.
DATES: Written comments concerning this draft guidance must be
submitted by January 6, 2000.
ADDRESSES: See the SUPPLEMENTARY INFORMATION section for information on
electronic access to the guidance. Submit written requests for single
copies on a 3.5'' diskette of the draft guidance document entitled
``Guidance on Information Disclosure by Manufacturers to Assemblers for
Diagnostic X-ray Systems'' to the Division of Small Manufacturers
Assistance (HFZ-220), Center for Devices and Radiological Health, Food
and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send
two self-addressed adhesive labels to assist that office in processing
your request, or fax your request to 301-443-8818.
Submit written comments concerning this guidance must be submitted
to the Dockets Management Branch, (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Comments should be identified with the docket number found in brackets
in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Thomas M. Jakub, Center for Devices
and Radiological Health (HFZ-322), Food and Drug Administration, 9024
Gaither Rd., Rockville, MD 20850, 301-594-4591.
SUPPLEMENTARY INFORMATION:
I. Background
The purpose of the Radiation Control for Health and Safety Act of
1968 (RCHSA) Public Law 90-602, is to protect the public from the
unnecessary or dangerous electronic product radiation by establishing
performance standards. Under the authority of RCHSA, now incorporated
into the Federal Food, Drug, and Cosmetic Act (the act) at section 532
(21 U.S.C. 360ii), FDA issued regulations that require manufacturers to
provide information to assemblers, users, and any one else upon
request, that is needed to ensure compliance with applicable federal
performance standards. The performance standards establish calculated
criteria that reduce or maintain x-ray exposure to the patient and
operator at the lowest possible level. The scope of information that
manufacturers must provide includes instructions, installation,
adjustment, and testing (AIAT) of x-ray components (21 CFR 1020.30(g)).
With the advancement of technology, use of computers and corresponding
software, manufacturers need clarification about what information must
be disclosed to satisfy the requirements of AIAT disclosure. The
regulation states that manufacturers shall provide AIAT information,
``* * * at cost not to exceed the cost of publication and distribution*
* *.'' The cost manufacturers charge for AIAT software required under
the guidance document should permit the manufacturer to recover its
expenses in producing the additional unit of the software, but should
not include initial development costs or a profit margin. FDA is
especially interested in receiving comments from interested parties on
the issue of cost under the performance standard.
II. Significance of Guidance
This draft guidance document represents the agency's current
thinking on information disclosure by manufacturers to assemblers for
diagnostic x-ray systems. It does not create or confer any rights for
or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
applicable statute, regulations, or both. The agency has adopted good
guidance practices (GGP's), which set forth the agency's policies and
procedures for the development, issuance, and use of guidance documents
(62 FR 8961, February 27, 1997). This guidance document is issued as a
Level 1 guidance consistent with GGP's.
III. Electronic Access
In order to receive ``Guidance on Information Disclosure by
Manufacturers to Assemblers for Diagnostic X-ray Systems'' via your fax
machine, call the CDRH Facts-On-Demand (FOD) system at 800-899-0381 or
301-827-0111 from a touch-tone telephone. At the first voice prompt
press 1 to access DSMA Facts, at second
[[Page 54902]]
voice prompt press 2, and then enter the document number (2619)
followed by the pound sign (#). Then follow the remaining voice prompts
to complete your request.
Persons interested in obtaining a copy of the guidance may also do
so using the World Wide Web (WWW). CDRH maintains an entry on the WWW
for easy access to information including text, graphics, and files that
may be downloaded to a personal computer with access to the WWW.
Updated on a regular basis, the CDRH home page includes ``Guidance on
Information Disclosure by Manufacturers to Assemblers for Diagnostic X-
ray Systems,'' device safety alerts, Federal Register reprints,
information on premarket submissions (including lists of approved
applications and manufacturers' addresses), small manufacturers'
assistance, information on video conferencing and electronic
submissions, Mammography Matters, and other device-oriented
information. The CDRH home page may be accessed at http://www.fda.gov/
cdrh. ``Guidance on Information Disclosure by Manufacturers to
Assemblers for Diagnostic X-ray Systems'' will be available at http://
www.fda.gov/cdrh/oc.
IV. Comments
Interested persons may submit to the Dockets Management Branch
(address above) written comments regarding this draft guidance. Two
copies of any comments are to be submitted, except that individuals may
submit one copy. 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 between 9 a.m. and 4 p.m., Monday through
Friday.
Dated: September 23, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 99-26220 Filed 10-7-99; 8:45 am]
BILLING CODE 4160-01-F
