[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