[Federal Register: April 22, 2003 (Volume 68, Number 77)]
[Notices]               
[Page 19834-19835]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22ap03-90]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03D-0141]

 
Guidance for Industry and FDA; 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; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance 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.'' This guidance document describes a means by which 
optical impression systems for the computer assisted design and 
manufacturing CAD/CAM of dental restorations may comply with the 
requirement of special controls for class II devices. Elsewhere in this 
issue of the Federal Register, FDA is publishing a final rule to exempt 
the type device from premarket notification requirements and establish 
this guidance document as the special control for the type device. This 
guidance document is immediately in effect as the special control for 
optical impression systems for CAD/CAM, but it remains subject to 
comment in accordance with the agency's good guidance practices (GGPs).

DATES: Submit written or electronic comments on this guidance at any 
time.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of 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'' to the Division of Small Manufacturers, 
International, and Consumer Assistance (HFZ-220), Center for Devices 
and Radiological Health (CDRH), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive 
labels to assist that office in processing your request, or fax your 
request to 301-443-8818. Submit written comments concerning this 
guidance to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://www.fda.gov/dockets/ecomments. 
Comments should be identified with the docket number found in brackets 
in the heading of this document. See the SUPPLEMENTARY INFORMATION 
section for information on electronic access to the guidance.

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. Background

    The guidance provides FDA's recommendations to manufacturers for 
evaluating and labeling optical impression systems for CAD/CAM of 
dental restorations. An optical impression system for CAD/CAM of dental 
restorations 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.
    Following the effective date of the final rule exempting this type 
of device, manufacturers of optical impression systems for CAD/CAM of 
dental restorations will need to address the issues covered in this 
special control guidance. However, the manufacturer need only show that 
its device meets the recommendations of the guidance or in some other 
way provides equivalent assurances of safety and effectiveness.
    Elsewhere in this issue of the Federal Register, FDA is publishing 
a final rule exempting optical impression systems for CAD/CAM of dental 
restorations from the premarket notification requirements under section 
510(m) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 
360(m)) and establishing this guidance document as the special control 
for the device.
    Section 510(m)(2) of the act provides that 1 day after the 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.

[[Page 19835]]

    Because of the limited timeframes established by section 510(m) of 
the act, FDA has determined, under Sec.  10.115(g)(2) (21 CFR 
10.115(g)(2)), that it is not feasible to allow for public 
participation before issuing this guidance as a final guidance 
document. Therefore, FDA is issuing this guidance document as a level 1 
guidance document that is immediately in effect. FDA will consider any 
comments that are received in response to this notice to determine 
whether to amend the guidance document.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's GGPs regulation 
(21 CFR 10.115). The guidance represents the agency's current thinking 
on optical impression systems for CAD/CAM. It does not create or confer 
any rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach may be used if such approach satisfies 
the requirements of the applicable statute and regulations.

III. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES), written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper 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 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

IV. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). 
The labeling provisions addressed in the guidance have been approved by 
OMB under the PRA under OMB control number 0910-0485.

V. Electronic Access

    To receive a copy of ``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'' by fax machine, call the CDRH Facts-On-Demand system at 800-
899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter 
the system. At the second voice prompt, press 1 to order a document. 
Enter the document number (1203) followed by the pound sign 
(). Follow the remaining voice prompts to complete your 
request.
    Persons interested in obtaining a copy of the guidance may also do 
so by using the Internet. CDRH maintains an entry on the Internet for 
easy access to information including text, graphics, and files that may 
be downloaded to a personal computer with Internet access. Updated on a 
regular basis, the CDRH home page includes device safety alerts, 
Federal Register reprints, information on premarket submissions 
(including lists of approved applications and manufacturers' 
addresses), small manufacturer's assistance, information on video 
conferencing and electronic submissions, Mammography Matters, and other 
device-oriented information. The CDRH Web site may be accessed at 
http://www.fda.gov/cdrh. A search capability for all CDRH guidance 
documents is available at http://www.fda.gov/cdrh/guidance.html. 
Guidance documents are also available on the Dockets Management Branch 
Internet site at http://www.fda.gov/ohrms/dockets.

    Dated: April 16, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-9870 Filed 4-21-03; 8:45 am]

BILLING CODE 4160-01-S