[Federal Register: April 2, 2001 (Volume 66, Number 63)]
[Notices]
[Page 17564-17565]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02ap01-66]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-4130]
Medical Devices; Information Disclosure by Manufacturers to
Assemblers for Diagnostic X-Ray Systems; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; availability of guidance.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a final guidance entitled ``Information Disclosure by
Manufacturers to Assemblers for Diagnostic X-Ray Systems; Final
Guidance for Industry and FDA.'' This guidance document is intended to
provide guidance to the industry about meeting requirements for
disclosure to assemblers, and to others upon request, of certain types
of information at a cost not to exceed the cost of publication and
distribution to ensure that x-ray systems will meet Federal performance
standards.
DATES: Submit written comments on agency guidances at any time.
ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of the guidance document entitled ``Information Disclosure by
Manufacturers to Assemblers for Diagnostic X-Ray Systems; Final
Guidance for Industry and FDA'' 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. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance.
Submit written comments concerning the guidance to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Thomas M. Jakub, Center for Devices
and Radiological Health (HFZ-322), Food and Drug Administration, 2094
Gaither Rd., Rockville, MD 20850, 301-594-4591.
SUPPLEMENTARY INFORMATION:
I. Background
This final Level 1 guidance document entitled ``Information
Disclosure by Manufacturers to Assemblers for Diagnostic X-Ray Systems;
Final Guidance for Industry and FDA'' is intended to provide guidance
to diagnostic x-ray system manufacturers, users, assemblers, and others
concerning the requirement to disclose information about the assembly,
installation, adjustment, and testing (AIAT) of x-ray components for
diagnostic x-ray systems. (See Sec. 1020.30(g) (21 CFR 1020.30(g))).
With the advancement of technology and the use of computers with
corresponding software, manufacturers need clarification about what
information must be disclosed to satisfy the requirements of AIAT
disclosure. This final Level 1 guidance document supersedes the
corresponding draft guidance entitled ``Draft Guidance on Information
Disclosure by Manufacturers to Assemblers for Diagnostic X-Ray
Systems,'' which was announced in the Federal Register on October 8,
1999 (64 FR 54901). The comment period closed on January 6, 2000. The
agency received several comments and recommendations concerning the
draft guidance. A number of comments received by the agency addressed
issues that do not fall within the scope of the guidance and
Sec. 1020.30(g). The final guidance contains only minor changes from
the draft guidance.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115; 65 FR 56468, September 19, 2000).
This guidance document represents the agency's current thinking on
information disclosure by manufacturers to assemblers for diagnostic x-
ray systems, as required by Sec. 1020.30(g). 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 requirement of the applicable statutes and regulations.
III. Electronic Access
In order to receive ``Guidance on Information Disclosure by
Manufacturers to Assemblers for Diagnostic X-Ray Systems; Final
Guidance for Industry and FDA'' via your fax machine, call the CDRH
Facts-On-Demand 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 the second 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 Internet. CDRH maintains an entry on the Internet for easy
access to information including text, graphics, and files that may be
downloaded to a personal computer with access to the Internet. Updated
on a regular basis, the CDRH home page includes ``Guidance on
Information Disclosure by Manufacturers to Assemblers for Diagnostic X-
Ray Systems; Final Guidance for Industry and FDA,'' 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; Final
Guidance for Industry and FDA'' is also available at http://
www.fda.gov/cdrh/comp/2619.html. Guidance documents are also available
on the Dockets Management Branch website at http://www.fda.gov/ohrms/
dockets/default.htm.
IV. Comments
Interested persons may, at any time, submit written comments
regarding the guidance to the Dockets Management
[[Page 17565]]
Branch (address above). 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 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: March 26, 2001.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 01-8058 Filed 3-28-01; 3:43 pm]
BILLING CODE 4160-01-S