[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Medical Devices; Draft Guidance on Information Disclosure by 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availability of a draft guidance entitled ``Guidance on Information 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 This draft guidance document provides guidance to industry 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draft guidance explains what information must be disclosed to ensure 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DATES: Written comments concerning this draft guidance must be 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copies on a 3.5'' diskette of the draft guidance document entitled 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