Source: https://www.federalregister.gov/documents/2003/04/22/03-9869/medical-devices-exemption-from-premarket-notification-class-ii-devices-optical-impression-systems
Timestamp: 2019-12-12 01:05:33
Document Index: 346942921

Matched Legal Cases: ['art 807', '§\u2009872', '§\u2009872', '§\u2009872', '§\u2009872', '§\u2009872', '§\u2009872', 'art 807', '§\u2009872', '§\u2009872']

Federal Register :: Medical Devices; Exemption From Premarket Notification; Class II Devices; Optical Impression Systems for Computer Assisted Design and Manufacturing
Medical Devices; Exemption From Premarket Notification; Class II Devices; Optical Impression Systems for Computer Assisted Design and Manufacturing
A Rule by the Food and Drug Administration on 04/22/2003
This rule is effective April 22, 2003.
Docket No. 02P-0494
https://www.federalregister.gov/d/03-9869 https://www.federalregister.gov/d/03-9869
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).
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.
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 Start Printed Page 19737that list in the Federal Register of January 21, 1998 (63 FR 3142).
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.
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 § 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 § 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 § 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 § 872.1(e) to direct the reader to the Web site for guidance documents.
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.
2. Section 872.1 is amended by adding paragraph (e) to read as follows:
(e) Guidance documents referenced in this part are available on the Internet at http://www.fda.gov/​cdrh.guidance.html.
3. Section 872.3660 is amended by revising paragraph (b) to read as follows:
§ 872.3660
4. Section 872.3661 is added to subpart D to read as follows:
§ 872.3661
(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 § 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 § 872.1(e).
[FR Doc. 03-9869 Filed 4-21-03; 8:45 am]