[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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