[Federal Register Volume 63, Number 145 (Wednesday, July 29, 1998)]
[Rules and Regulations]
[Pages 40364-40366]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20241]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 862
[Docket No. 96P-0228]
Medical Devices; Reclassification and Codification of Vitamin D
Test System
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that it
has issued an order in the form of a letter to INCSTAR Corp.
reclassifying INCSTAR 25-Hydroxyvitamin D 125I
Radioimmunoassay (RIA). This radioimmunoassay device is intended for
use in clinical laboratories for the quantitative determination of 25-
hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of
vitamin D in serum or plasma to be used in the assessment of vitamin D
sufficiency. The device and substantially equivalent devices of this
generic type were reclassified from class III (premarket approval) to
class II (special controls). Accordingly, the order is being codified
in the Code of Federal Regulations.
EFFECTIVE DATES: The regulation is effective August 28, 1998. The
reclassification was effective September 24, 1996.
FOR FURTHER INFORMATION CONTACT: Sharon K. Lappalainen, Center for
Devices and Radiological Health (HFZ-440), Food and Drug
Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-594-1243.
SUPPLEMENTARY INFORMATION:
I. Background (Regulatory Authorities)
The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301
et seq.), as amended by the Medical Device Amendments of 1976 (the 1976
amendments) (Pub. L. 94-295), the Safe Medical Devices Act of 1990 (the
SMDA) (Pub. L. 101-629), and the Food and Drug Administration
Modernization Act of 1997 (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 1976
amendments), generally referred to as preamendments devices, are
classified after FDA has: (1) Received a recommendation from a device
classification panel (an FDA advisory committee); (2) published the
panel's recommendation for comment, along with a proposed regulation
[[Page 40365]]
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
Devices that were not in commercial distribution prior to May 28,
1976, generally referred to as postamendments devices, are classified
automatically by statute (section 513(f) of the act into class III
without any FDA rulemaking process. Those devices remain in class III
and require premarket approval, unless and until: (1) The device is
reclassified into class I or II; (2) FDA issues an order classifying
the device into class I or II in accordance with new section 513(f)(2)
of the act as amended by FDAMA; or (3) FDA issues an order finding the
device to be substantially equivalent, under section 513(i) of the act,
to a predicate device that does not require premarket approval. 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 21 CFR
part 807 of the regulations.
A preamendments device that has been classified into class III may
be marketed, by means of premarket notification procedures, without
submission of a premarket approval application (PMA) until FDA issues a
final regulation under section 515(b) of the act (21 U.S.C. 360e(b))
requiring premarket approval.
Reclassification of postamendments devices is governed by section
513(f)(3) of the act, formerly section 513(f)(2) of the act. This
section provides that FDA may initiate the reclassification of a device
classified into class III under section 513(f)(1) of the act, or the
manufacturer or importer of a device may petition the Secretary of the
Department of Health and Human Services (the Secretary) for the
issuance of an order classifying the device in class I or class II.
FDA's regulations in Sec. 860.134 (21 CFR 860.134) set forth the
procedures for the filing and review of a petition for reclassification
of such class III devices. In order to change the classification of the
device, it is necessary that the proposed new class have sufficient
regulatory controls to provide reasonable assurance of the safety and
effectiveness of the device for its intended use.
FDAMA added paragraph (f)(2) in section 513 of the act that
addresses classification of postamendments devices. New paragraph
(f)(2) in section 513 of the act provides that upon receipt of a ``not
substantially equivalent'' determination, a 510(k) applicant may
request FDA to classify a postamendments device into class I or class
II. Within 60 days from the date of such a written request, FDA must
classify the device by written order. If FDA classifies the device into
class I or II, the applicant has then received clearance to market the
device and it can be used as a predicate device for other 510(k)'s. It
is expected that this will be used for low risk devices. This process
does not apply to devices that have been classified by regulation into
class III--i.e., preamendments class III devices, or class III devices
for which a PMA is appropriate.
Under section 513(f)(3)(B)(i) of the act, formerly section
513(f)(2)(B)(i) of the act, the Secretary may, for good cause shown,
refer a petition to a device classification panel. If a petition is
referred to a panel, the panel shall make a recommendation to the
Secretary respecting approval or denial of the petition. Any such
recommendation shall contain: (1) A summary of the reasons for the
recommendation, (2) a summary of the data upon which the recommendation
is based, and (3) an identification of the risks to health (if any)
presented by the device with respect to which the petition was filed.
On July 1, 1996, FDA filed the reclassification petition submitted
by INCSTAR Corp., requesting reclassification of the vitamin D test
system from class III to class II.
On the basis of FDA's review of the data submitted in the
reclassification petition, and after reviewing the panel's
recommendations on two previous petitions submitted in 1983 and 1985
regarding the quantitative measurement of vitamin D, FDA issued an
order to the petitioner, reclassifying vitamin D test system for use in
clinical laboratories for the quantitative determination of 25-OH-D and
other hydroxylated metabolites of vitamin D in serum or plasma to be
used in the assessment of vitamin D sufficiency, and substantially
equivalent devices of this generic type, from class III to class II.
Accordingly, as required by Sec. 860.134(b)(7) of the regulations, FDA
is announcing the reclassification of the vitamin D test system
intended for use in clinical laboratories for the quantitative
determination of 25-OH-D and other hydroxylated metabolites of vitamin
D in serum or plasma to be used in the assessment of vitamin D
sufficiency from class III into class II. In addition, FDA is issuing
the notice to codify the reclassification of the device by adding new
Sec. 862.1825.
II. Environmental Impact
The agency has determined under 21 CFR 25.34(b) that this
reclassification 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.
III. Analysis of Impacts
FDA has examined the impacts of this final rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354) (as
amended by the subtitle D of the Small Business Regulatory Fairness Act
of 1996 (Pub. L. 104-121)), and the Unfunded Mandates Reform Act of
1995 (Pub. L. 104-4). 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. Reclassification of this device from class III to
class II will relieve all manufacturers of the device of the cost of
complying with the premarket approval requirements of section 515 of
the act. Because reclassification will reduce regulatory costs with
respect to this device, it will impose no significant economic impact
on any small entities, and it may permit small potential competitors to
enter the marketplace by lowering their costs. The agency therefore
certifies that this final rule will not have a significant economic
impact on a substantial number of small entities. In addition, this
final rule will not impose costs of $100 million or more on either the
private sector or state, local, and tribal governments in the
aggregate, and therefore a summary statement or analysis under section
202(a) of the Unfunded Mandates Refund Act of 1995 is not required.
IV. Paperwork Reduction Act of 1995
FDA has determined that this final rule contains no collections of
information. Therefore, clearance by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 is not required.
[[Page 40366]]
List of Subjects in 21 CFR Part 862
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and
under authority delegated to the Commissioner of Food and Drugs, 21 CFR
part 862 is amended as follows:
PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
1. The authority citation for 21 CFR part 862 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
2. Section 862.1825 is added to subpart B to read as follows:
Sec. 862.1825 Vitamin D test system.
(a) Identification. A vitamin D test system is a device intended
for use in clinical laboratories for the quantitative determination of
25-hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of
vitamin D in serum or plasma to be used in the assessment of vitamin D
sufficiency.
(b) Classification. Class II (special controls).
Vitamin D test systems must comply with the following special
controls: (1) Labeling in conformance with 21 CFR 809.10 and (2)
compliance with existing standards of the National Committee on
Clinical Laboratory Standards.
Dated: July 17, 1998.
D.B. Burlington.
Director, Center for Devices and Radiological Health.
[FR Doc. 98-20241 Filed 7-28-98; 8:45 am]
BILLING CODE 4160-01-F