[Federal Register Volume 63, Number 46 (Tuesday, March 10, 1998)]
[Proposed Rules]
[Pages 11632-11634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-6150]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 880
[Docket No. 98N-0087]
General Hospital and Personal Use Devices; Classification of the
Apgar Timer, Lice Removal Kit, and Infusion Stand
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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[[Page 11633]]
SUMMARY: The Food and Drug Administration (FDA) is proposing to
classify the Apgar timer, lice removal kit, and infusion stand into
class I. FDA is also publishing the recommendations of the General
Hospital and Personal Use Devices Panel (the panel) regarding the
classification of the devices. After considering public comments on the
proposed classification, FDA will publish a final regulation
classifying the devices. This action is being taken under the Federal
Food, Drug, and Cosmetic Act (the act), as amended by the Medical
Device Amendments of 1976 (the amendments), the Safe Medical Devices
Act of 1990 (the SMDA), and the Food and Drug Administration
Modernization Act of 1997 (FDAMA).
DATES: Written comments by June 8, 1998. FDA proposes that any final
regulation based on this proposal become effective 30 days after its
date of publication in the Federal Register.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Patricia M. Cricenti, Center for
Devices and Radiological Health (HFZ-480), Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-
8913.
SUPPLEMENTARY INFORMATION:
I. Background
The act, as amended by the amendments (Pub. L. 94-295), the SMDA
(Pub. L. 101-629), and FDAMA (Pub. L. 105-115) established a
comprehensive system for the regulation of medical devices intended for
human use. Section 513 of the act (21 U.S.C. 360c) established three
categories (classes) of devices, depending on the regulatory controls
needed to provide reasonable assurance of their safety and
effectiveness. The three categories of devices are class I (general
controls), class II (special controls), and class III (premarket
approval). Under section 513 of the act, devices that were in
commercial distribution before May 28, 1976 (the date of enactment of
the amendments) are classified after FDA has: (1) Received a
recommendation from a device classification panel (an FDA advisory
committee); (2) published the panel's recommendations for comment,
along with a proposed regulation classifying the device; and (3)
published a final regulation classifying the device. A device that is
first offered in commercial distribution after May 28, 1976, and which
FDA determines to be substantially equivalent to a device classified
under this scheme is classified into the same class as the device to
which it is substantially equivalent. The agency determines whether new
devices are substantially equivalent to previously offered devices by
means of premarket notification procedures in section 510(k) of the act
(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
A device that was not in commercial distribution before May 28,
1976, and that has not been found by FDA to be substantially equivalent
to a legally marketed predicate device, is classified automatically by
statute (section 513(f) of the act) into class III without any FDA
rulemaking process.
In 1980, when other general hospital and personal use devices were
classified (45 FR 69678 through 69737, October 21, 1980), the Apgar
timer, lice removal kit, and infusion stand were inadvertently omitted.
The panel made classification recommendations for these preadmendment
devices during its July 18, 1995, meeting (Ref. 1).
II. Device Descriptions
FDA is proposing the following device descriptions based on the
panel's recommendations (Ref. 1) and the agency's review:
(1) The Apgar timer is a device intended to alert a health care
provider that the Apgar score of a newborn infant should be taken;
(2) The lice removal kit is a comb or comb-like device intended to
kill and/or remove lice and nits from head and body hair; the kit may
or may not be battery operated; and
(3) The infusion stand is a stationary or movable stand intended to
hold infusion fluids, infusion accessories, and related devices. The
infusion stand may be used to hold other medical devices.
III. Recommendations of the Panel
In the public meeting held on July 18, 1995, the panel unanimously
recommended that the Apgar timer, lice removal kit, and infusion stand
be classified into class I (general controls). The panel also
recommended that the devices should be exempted from premarket
notification submission procedures (section 510(k) of the act). The
panel further recommended that the lice removal kit and infusion stand
should be exempted from the current good manufacturing practice (CGMP)
requirements (section 520(f) of the act (21 U.S.C. (360j)(f))), with
the exception of other requirements concerning reports (Sec. 820.180
(21 CFR 820.180)) and complaint files (Sec. 820.198 (21 CFR 820.198)).
The panel recommended that the Apgar timer should be exempt from the
CGMP requirements and from other requirements concerning records and
reports (section 519 of the act (21 U.S.C. 360i)).
IV. Summary of the Reasons for the Recommendations
The panel concluded that the safety and effectiveness of the Apgar
timer, lice removal kit, and infusion stand can be reasonably ensured
by general controls. Specifically, the safety and effectiveness of the
lice detector kit and infusion stand can be reasonably ensured by the
general controls of: (1) Registration and listing (section 510 of the
act) and (2) the general requirements concerning reports (Sec. 820.180)
and complaint files (Sec. 820.198); and the safety and effectiveness of
the Apgar timer can be reasonably ensured by registration and listing
(section 510 of the act).
V. Risks to Health
The panel identified no specific risks associated with the use of
the Apgar timer, lice removal kit, or infusion stand.
VI. Summary of the Data Upon Which the Proposed Recommendation is
Based
The panel based its recommendations on expert testimony presented
to the panel and on the panel members' personal knowledge of and
clinical experience with the Apgar timer, lice removal kit, and
infusion stand.
VII. FDA's Tentative Finding
FDA tentatively concurs with the recommendations of the panel that
the Apgar timer, lice detector kit, and infusion stand should be
classified into class I (general controls). FDA believes that
sufficient information exists to determine that general controls will
provide reasonable assurance of the safety and effectiveness of these
devices.
After the panel meeting, on November 21, 1997, the President signed
into law FDAMA (Pub. L. 105-115). Section 206 of FDAMA, in part, added
a new section 510(l) to the act. Under section 501 of FDAMA, new
section 510(l) became effective on February 19, 1998. New section
510(l) provides that a class I device is exempt from the premarket
notification requirements under section 510(k) of the act, unless the
device is intended for a use which is of substantial importance in
preventing impairment of human health or it presents a potential
unreasonable risk of illness or injury (hereafter ``reserved
criteria''). FDA believes that these devices do not meet the reserved
criteria
[[Page 11634]]
and, therefore, will be exempt from premarket notification under
section 510(l) of the act.
FDA, however, disagrees that the lice detector kit and infusion
stand should be exempt from the CGMP requirements (section 520(f) of
the act). FDA's believes that the CGMP requirements are necessary to
ensure product quality. FDA believes, however, that the Apgar timer is
a very simple device that may be exempted from the CGMP regulations
Consistent with the purpose of the act, class I (general controls),
as defined by section 513(a)(1) of the act, would provide the least
amount of regulation necessary to reasonably ensure that current and
future Apgar timers, lice removal kits, and infusion stands are safe
and effective.
The agency, therefore, proposes to classify the Apgar timer, lice
removal kit, and infusion stand into class I in 21 CFR part 880
(general hospital and personal use devices).
VIII. Reference
The following reference has been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. General Hospital and Personal Use Devices Panel, 30th
meeting, meeting and transcript minutes, July 18, 1995.
IX. Environmental Impact
The agency has determined under 21 CFR 25.34(b) that this proposed
classification 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.
X. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866, and the Regulatory Flexibility Act (5 U.S.C. 601-612).
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. As noted previously, FDA may classify devices into
one of three regulatory classes according to the degree of control
needed to provide reasonable assurance of safety and effectiveness. For
these three devices, FDA is proposing that they be classified into
class I, the lowest level of control allowed. Therefore, the agency
certifies that the proposed rule will not have a significant economic
impact on a substantial economic impact on a substantial number of
small entities. Therefore, under the Regulatory Flexibility Act, no
further analysis is required.
XI. Comments
Interested persons may, on or before June 8, 1998 submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. 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. Received comments may be seen in the office above between 9
a.m. and 4 p.m., Monday through Friday.
List of Subjects in 21 CFR Part 880
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 880 be amended as follows:
PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES
1. The authority citation for 21 CFR part 880 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
2. Section 880.2930 is added to subpart C to read as follows:
Sec. 880.2930 Apgar timer.
(a) Identification. The Apgar timer is a device intended to alert a
health care provider that the Apgar score of an new born infant should
be taken.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter. The device is also exempt from the current good
manufacturing practice requirements in part 820 of this chapter, with
the exception of Sec. 820.180 of this chapter, with respect to general
requirements concerning records, and Sec. 820.198 of this chapter, with
respect to complaint files.
3. Section 880.5960 is added to subpart F to read as follows:
Sec. 880.5960 Lice removal kit.
(a) Identification. The lice removal kit is a comb or comb-like
device intended to kill and/or remove lice and nits from head and body
hair. It may or may not be battery operated.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter.
4. Section 880.6990 is added to subpart G to read as follows:
Sec. 880.6990 Infusion stand.
(a) Identification. The infusion stand is a stationary or movable
stand designed to hold infusion fluids, infusion accessories, and
related devices. The infusion stand may be used to hold other medical
devices.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter.
Dated: February 27, 1998.
D. B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-6150 Filed 3-9-98; 8:45 am]
BILLING CODE 4160-01-F
