Source: https://www.federalregister.gov/articles/2013/12/30/2013-31217/dental-devices-reclassification-of-temporary-mandibular-condyle-prosthesis
Timestamp: 2014-04-23 17:15:22
Document Index: 162721979

Matched Legal Cases: ['art 872', 'art 872', '§ 872', '§ 872', '§ 872', '§ 872']

Federal Register | Dental Devices; Reclassification of Temporary Mandibular Condyle Prosthesis
-79310 (3 pages)
Shorter URL: https://federalregister.gov/a/2013-31217 Related Topics
Dental Devices; Reclassification of Temporary Mandibular Condyle Prosthesis - CLOSED
FDA relies upon “valid scientific evidence” in the classification process to determine the level of regulation for devices. To be considered in the reclassification process, the “valid scientific evidence” upon which the Agency relies must be publicly available. Publicly available information excludes trade secret and/or confidential commercial information, e.g., the contents of a pending premarket approval application (PMA). (See section 520(c) of the FD Act (21 U.S.C. 360j(c)).) Section 520(h)(4) of the FD Act, added by FDAMA, provides that FDA may use, for reclassification of a device, certain information in a PMA 6 years after the application has been approved. This includes information from clinical and preclinical tests or studies that demonstrate the safety or effectiveness of the device but does not include descriptions of methods of manufacture or product composition and other trade secrets.
Section 513(e)(1) of the FD&C Act sets forth the process for issuing a final order. Specifically, prior to the issuance of a final order reclassifying a device, the following must occur: (1) Publication of a proposed order in the Federal Register; (2) a meeting of a device classification panel described in section 513(b) of the FD&C Act; and (3) consideration of comments to a public docket. FDA published a proposed order to reclassify this device in the Federal Register of February 7, 2013 (78 FR 9010) (the 2013 proposed order). FDA received and has considered one comment on the 2013 proposed order, as discussed in section II of this document. On February 12, 1997, FDA held a meeting of a device classification panel described in section 513(b) of the FD Act with respect to temporary mandibular condyle prosthesis (the 1997 Panel), and therefore, has met this requirement under section 513(e)(1) of the FD Act. As explained further in section II of the 2013 proposed order, a meeting of a device classification panel described in section 513(b) of the FD Act took place in 1997 to discuss whether temporary mandibular condyle prosthesis should be reclassified or remain in class III, and the 1997 Panel recommended that the device be reclassified into class II because there was sufficient information to establish special controls. FDA is not aware of new information since the 1997 Panel that would provide a basis for a different recommendation or findings.
Under section 513(e) of the FD Act, FDA is adopting its findings as published in the preamble to the 2013 proposed order. FDA is issuing this final order to reclassify temporary mandibular condyle prostheses from class III to class II, rename them temporary mandibular condyle reconstruction plates, and establish special controls by revising part 872 (21 CFR part 872).
IV. Electronic Access to the Special Controls Guideline Back to Top
Persons interested in obtaining a copy of the guideline may do so by using the Internet. A search capability for all Center for Devices and Radiological Health guidelines and guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. The guideline is also available at http://www.regulations.gov.
VII. Clarifications to Special Controls Guidelines Back to Top
The special controls guideline reflects changes the Agency is making to clarify its position on the binding nature of special controls. The changes include referring to the document as a “guideline,” as that term is used in section 513(a) of the FD Act, which the Secretary has developed and disseminated to provide a reasonable assurance of safety and effectiveness for class II devices, and not a “guidance,” as that term is used in 21 CFR 10.115. The guideline also clarifies that firms will need either to (1) comply with the particular mitigation measures set forth in the special controls guideline or (2) use alternative mitigation measures, but demonstrate to the Agency's satisfaction that those alternative measures identified by the firm will provide at least an equivalent assurance of safety and effectiveness. Finally, the guideline uses mandatory language to emphasize that firms must comply with special controls to legally market their class II devices. These revisions do not represent a change in FDA's position about the binding effect of special controls, but rather are intended to address any possible confusion or misunderstanding.
Prior to the amendments by FDASIA, section 513(e) of the FD&C Act provided for FDA to issue regulations to reclassify devices. Although section 513(e) of the FD&C Act as amended requires FDA to issue final orders rather than regulations, FDASIA also provides for FDA to revoke previously issued regulations by order. FDA will continue to codify classifications and reclassifications in the Code of Federal Regulations (CFR). Changes resulting from final orders will appear in the CFR as changes to codified classification determinations or as newly codified orders. Therefore, under section 513(e)(1)(A)(i) of the FD&C Act, as amended by FDASIA, in this final order, we are revoking the requirements in § 872.3960 related to the classification of TMCRPs as Class III devices and codifying the reclassification of TMCRPs into Class II.
2.Section 872.3960 is amended by revising paragraph (c) to read as follows: § 872.3960 Mandibular condyle prosthesis.
3.Section 872.4770 is added to subpart E to read as follows: § 872.4770 Temporary mandibular condyle reconstruction plate.
(b) Classification. Class II (special controls). The special controls for this device is FDA's guideline entitled “Temporary Mandibular Condyle Reconstruction Plate Class II Special Controls Guideline.” See § 872.1(e) for the availability of this guidance document.