[Federal Register Volume 60, Number 137 (Tuesday, July 18, 1995)]
[Rules and Regulations]
[Page 36639]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-17640]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 892

[Docket No. 94N-0345]


Medical Devices; Classification of Transilluminators 
(Diaphanoscopes or Lightscanners) for Breast Evaluation

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule 
to classify the transilluminator (diaphanoscope or lightscanner) for 
breast evaluation into class III (premarket approval). This action is 
necessary to require manufacturers of transilluminators to submit a 
premarket approval application that includes information concerning 
safety and effectiveness tests for the device. This action is being 
taken under the Federal Food, Drug, and Cosmetic Act as amended by the 
Medical Device Amendments of 1976 and the Safe Medical Devices Act of 
1990.

EFFECTIVE DATE: August 17, 1995.

FOR FURTHER INFORMATION CONTACT: Robert A. Phillips, Center for Devices 
and Radiological Health (HFZ-470), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1212.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 13, 1995 
(60 FR 3168), FDA issued a proposed rule to classify transilluminators 
(diaphanoscopes or lightscanners) for breast evaluation into class III. 
The effect of classifying a device into class III is to require each 
manufacturer of the device to submit to FDA a premarket approval 
application that includes information concerning safety and 
effectiveness tests for the device. A period of 90 days was provided 
for interested persons to submit written comments to FDA. FDA did not 
receive any comments on the proposal. Accordingly, the proposed rule is 
being adopted without change.

Environmental Impact

    The agency has determined under 21 CFR 25.24(e)(2) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this final rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, the final 
rule is not a significant regulatory action as defined by the Executive 
Order and so is not subject to review under the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because the agency believes only a small number of 
firms will be affected by this rule, the agency certifies that the 
final rule will not have a significant economic impact on a substantial 
number of small entities. Therefore, under the Regulatory Flexibility 
Act, no further analysis is required.

List of Subjects in 21 CFR Part 892

    Medical devices, Radiation protection, X-rays.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and 
under authority delegated to the Commissioner of Food and Drugs, 21 CFR 
part 892 is amended as follows:

PART 892--RADIOLOGY DEVICES

    1. The authority citation for 21 CFR part 892 continues to read as 
follows:

    Authority: Secs. 501, 510, 513, 520, 701 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 371).


    2. New Sec. 892.1990 is added to subpart B to read as follows:


Sec. 892.1990  Transilluminator for breast evaluation.

    (a) Identification. A transilluminator, also known as a 
diaphanoscope or lightscanner, is an electrically powered device that 
uses low intensity emissions of visible light and near-infrared 
radiation (approximately 700-1050 nanometers (nm)), transmitted through 
the breast, to visualize translucent tissue for the diagnosis of 
cancer, other conditions, diseases, or abnormalities.
    (b) Classification. Class III (premarket approval).
    (c) Date premarket approval (PMA) or notice of completion of a 
product development protocol (PDP) is required. The effective date of 
the requirement for premarket approval has not been established. See 
Sec. 892.3.

    Dated: July 10, 1995.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 95-17640 Filed 7-17-95; 8:45 am]
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