[Federal Register Volume 68, Number 77 (Tuesday, April 22, 2003)]
[Rules and Regulations]
[Pages 19736-19738]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-9869]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 872

[Docket No. 02P-0494]


Medical Devices; Exemption From Premarket Notification; Class II 
Devices; Optical Impression Systems for Computer Assisted Design and 
Manufacturing

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is publishing an order 
granting a petition requesting exemption from the premarket 
notification requirements for data acquisition units for ceramic dental 
restoration systems. This rule exempts from premarket notification data 
acquisition units for ceramic dental restoration systems and 
establishes a guidance document as a special control for this device. 
FDA is publishing this order in accordance with the Food and Drug 
Administration Modernization Act of 1997 (FDAMA).

DATES: This rule is effective April 22, 2003.

FOR FURTHER INFORMATION CONTACT: Kevin Mulry, Center for Devices and 
Radiological Health (HFZ-480), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-827-5283, ext 185.

SUPPLEMENTARY INFORMATION:

I. Statutory Background

    Under section 513 of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 360c), FDA must classify devices into one of three 
regulatory classes: Class I, Class II, or Class III. FDA classification 
of a device is determined by the amount of regulation necessary to 
provide a reasonable assurance of safety and effectiveness. Under the 
Medical Device Amendments of 1976 (the 1976 amendments (Public Law 94-
295)), as amended by the Safe Medical Devices Act of 1990 (the SMDA 
(Public Law 101-629)), devices are to be classified into Class I 
(general controls) if there is information showing that the general 
controls of the act are sufficient to assure safety and effectiveness; 
into Class II (special controls), if general controls, by themselves, 
are insufficient to provide reasonable assurance of safety and 
effectiveness, but there is sufficient information to establish special 
controls to provide such assurance; and into Class III (premarket 
approval), if there is insufficient information to support classifying 
a device into Class I or Class II and the device is a life-sustaining 
or life-supporting device or is for a use that is of substantial 
importance in preventing impairment of human health, or presents a 
potential unreasonable risk of illness or injury.
    Most generic types of devices that were on the market before the 
date of the 1976 amendments (May 28, 1976) (generally referred to as 
preamendments devices) have been classified by FDA under the procedures 
set forth in section 513(c) and (d) of the act through the issuance of 
classification regulations into one of these three regulatory classes. 
Devices introduced into interstate commerce for the first time on or 
after May 28, 1976 (generally referred to as postamendments devices), 
are classified through the premarket notification process under section 
510(k) of the act (21 U.S.C. 360(k)). Section 510(k) of the act and the 
implementing regulations (21 CFR part 807) require persons who intend 
to market a new device to submit a premarket notification report 
(510(k)) containing information that allows FDA to determine whether 
the new device is ``substantially equivalent'' within the meaning of 
section 513(i) of the act to a legally marketed device that does not 
require premarket approval.
    On November 21, 1997, the President signed into law FDAMA (Public 
Law 105-115). Section 206 of FDAMA, in part, added a new section 510(m) 
to the act. Section 510(m)(1) of the act requires FDA, within 60 days 
after enactment of FDAMA, to publish in the Federal Register a list of 
each type of Class II device that does not require a report under 
section 510(k) of the act to provide reasonable assurance of safety and 
effectiveness. Section 510(m) of the act further provides that a 510(k) 
will no longer be required for these devices upon the date of 
publication of the list in the Federal Register. FDA published

[[Page 19737]]

that list in the Federal Register of January 21, 1998 (63 FR 3142).
    Section 510(m)(2) of the act provides that 1 day after date of 
publication of the list under section 510(m)(1) of the act, FDA may 
exempt a device on its own initiative, or upon petition of an 
interested person, if FDA determines that a 510(k) is not necessary to 
provide reasonable assurance of the safety and effectiveness of the 
device. This section requires FDA to publish in the Federal Register a 
notice of intent to exempt a device, or of the petition, and to provide 
a 30-day comment period. Within 120 days of publication of this 
document, FDA must publish in the Federal Register its final 
determination regarding the exemption of the device that was the 
subject of the notice. If FDA fails to respond to a petition under this 
section within 180 days of receiving it, the petition shall be deemed 
granted.

II. Criteria for Exemption

    There are a number of factors FDA may consider to determine whether 
a 510(k) is necessary to provide reasonable assurance of the safety and 
effectiveness of a Class II device. These factors are discussed in the 
guidance that the agency issued on February 19, 1998, entitled 
``Procedures for Class II Device Exemptions From Premarket 
Notification, Guidance for Industry and CDRH Staff.'' That guidance can 
be obtained through the Internet on the CDRH home page at http://www.fda.gov/cdrh.guidance.html or by facsimile through CDRH Facts-on-
Demand at 1-800-899-0381 or 301-827-0111. Specify ``159'' when prompted 
for the document shelf number.

III. Petition

    On October 25, 2002, FDA received a petition requesting an 
exemption from premarket notification for data acquisition units for 
ceramic dental restoration systems. These devices are currently 
classified under Sec.  872.3660 Impression material (21 CFR 872.3660) 
as an accessory. In the Federal Register of January 30, 2003 (67 FR 
2787), FDA published a notice announcing that this petition had been 
received and provided opportunity for interested persons to submit 
comments on the petition by March 3, 2003. FDA did not receive any 
comments.
    FDA has determined that maintaining classification of the data 
acquisition units in Class II and exempting them from the premarket 
notification requirements, with the guidance document as a special 
control, will provide reasonable assurance of the safety and 
effectiveness of these devices and, therefore, they meet the criteria 
for exemption from the premarket notification requirements. For 
precision and clarity, FDA is: (1) Designating these devices as 
``optical impression systems for computer assisted design and 
manufacturing (CAD/CAM);'' (2) placing them in new Sec.  872.3661; (3) 
exempting them from the premarket notification requirements; and (4) 
establishing the guidance document entitled ``Class II Special Controls 
Guidance Document: Optical Impression Systems for Computer Assisted 
Design and Manufacturing (CAD/CAM) of Dental Restorations; Guidance for 
Industry and FDA'' as the special control for these devices. Elsewhere 
in this issue of the Federal Register, FDA is announcing the 
availability of this guidance document. Following the effective date of 
this final rule any firm submitting a 510(k) premarket notification for 
an optical impression system for CAD/CAM will need to address the 
issues covered in the special control guidance. However, the firm need 
only show that its device meets the recommendations of the guidance or 
in some other way provides equivalent assurances of safety and 
effectiveness. All other devices classified under Sec.  872.3660 will 
continue to be classified in that section and subject to the same 
regulatory requirements as before.
    For the benefit of the reader, FDA is also adding a Sec.  872.1(e) 
to direct the reader to the Web site for guidance documents.

IV. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) 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.

V. 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), and 
the Unfunded Mandates Reform Act of 1995 (Public Law 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. This rule will relieve a burden and simplify the 
marketing of these devices. The guidance document is based on existing 
review practices and will not impose any new burdens on these devices. 
The agency, therefore, 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.

VI. Paperwork Reduction Act of 1995

    FDA concludes 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.

VII. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the order and, consequently, a federalism 
summary impact statement is not required.

List of Subjects in 21 CFR Part 872

    Medical devices.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
872 is amended as follows:

PART 872--DENTAL DEVICES

0
1. The authority citation for 21 CFR part 872 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Section 872.1 is amended by adding paragraph (e) to read as follows:


Sec.  872.1  Scope.

* * * * *

[[Page 19738]]

    (e) Guidance documents referenced in this part are available on the 
Internet at http://www.fda.gov/cdrh.guidance.html.

0
3. Section 872.3660 is amended by revising paragraph (b) to read as 
follows:


Sec.  872.3660  Impression material.

* * * * *
    (b) Classification. Class II (Special Controls).

0
4. Section 872.3661 is added to subpart D to read as follows:


Sec.  872.3661  Optical Impression Systems for CAD/CAM.

    (a) Identification. An optical impression system for computer 
assisted design and manufacturing (CAD/CAM) is a device used to record 
the topographical characteristics of teeth, dental impressions, or 
stone models by analog or digital methods for use in the computer-
assisted design and manufacturing of dental restorative prosthetic 
devices. Such systems may consist of a camera, scanner, or equivalent 
type of sensor and a computer with software.
    (b) Classification. Class II (Special Controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of the chapter subject to the limitations in Sec.  872.9. The 
special control for these devices is the FDA guidance document entitled 
``Class II Special Controls Guidance Document: Optical Impression 
Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of 
Dental Restorations; Guidance for Industry and FDA.'' For the 
availability of this guidance document, see Sec.  872.1(e).

    Dated: April 16, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-9869 Filed 4-21-03; 8:45 am]
BILLING CODE 4160-01-S