Source: https://www.federalregister.gov/documents/2013/12/30/2013-31217/dental-devices-reclassification-of-temporary-mandibular-condyle-prosthesis
Timestamp: 2018-04-26 11:59:51
Document Index: 470744794

Matched Legal Cases: ['art 872', 'art 872', 'art 812', 'art 807', 'art 814', 'art 801', '§\u2009872', '§\u2009872', '§\u2009872', '§\u2009872']

Federal Register :: Dental Devices; Reclassification of Temporary Mandibular Condyle Prosthesis
78 FR 79308
79308-79310 (3 pages)
2013-31217
FDA-2012-N-1239
IV. Electronic Access to the Special Controls Guideline
VII. Clarifications to Special Controls Guidelines
https://www.federalregister.gov/d/2013-31217 https://www.federalregister.gov/d/2013-31217
The Food and Drug Administration (FDA) is issuing a final order to reclassify temporary mandibular condyle prosthesis, a preamendments class III device, into class II (special controls), and rename the device “temporary mandibular condyle reconstruction plate.” FDA is also issuing the special controls guideline entitled “Temporary Mandibular Condyle Reconstruction Plate Class II Special Controls Guideline” that sets forth the special controls that are necessary to provide a reasonable assurance of the safety and effectiveness of the device.
On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA (126 Stat. 1056) amended section 513(e) of the FD&C Act, changing the mechanism for reclassifying a device from rulemaking to an administrative order.
Reevaluation of the data previously before the Agency is an appropriate basis for subsequent action where the reevaluation is made in light of newly available authority (see Bell, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762 F.Supp. 382, 388-391 (D.D.C. 1991)), or in light of changes in “medical science” (Upjohn, 422 F.2d at 951). Whether data before the Agency are old or new data, the “new information” to support reclassification under section 513(e) must be “valid scientific evidence,” as defined in section 513(a)(3) of the FD&C Act and 21 CFR 860.7(c)(2). (See, e.g., General Medical Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Association v. FDA, 766 F.2d 592 (D.C. Start Printed Page 79309Cir. 1985), cert. denied, 474 U.S. 1062 (1986).)
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&C 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&C 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&C 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.
In response to the 2013 proposed order to reclassify temporary mandibular condyle prostheses and rename the device temporary mandibular condyle reconstruction plates (TMCRPs), FDA received one comment. This comment disagreed with FDA's intent to reclassify these devices from class III to class II. The commenter believes that TMCRPs should be classified as class III (PMA) devices, similar to permanent mandibular condyle prostheses, because reclassification to class II (special controls) would allow TMCRPs to enter the market and be used off-label for permanent use. FDA disagrees with this comment. FDA generally does not regulate the practice of medicine but rather regulates the use of a device as indicated by the party offering the device for interstate commerce. The indications for TMCRP are limited to temporary use by the codified identification. FDA is requiring in the special control guideline for this device (see section IV of this final order) patient labeling for TMCRP devices that clearly indicate that the device “is intended for temporary use (defined as less than 24 months) only. It is not intended to permanently reconstruct the TMJ. It is not intended for permanent treatment of TMJ disorders.” FDA recommends that patients discuss the risks and benefits of any treatment with their surgeon, especially if off-label use is involved.
The commenter also states that the special controls are not rigorous enough and that clinical trials are necessary to provide a reasonable assurance of the device's safety and effectiveness. The commenter suggests that classification to class II (special controls) precludes FDA from requesting clinical data for these devices. FDA disagrees with this comment. FDA believes that the special controls provide a reasonable assurance of safety and effectiveness for TMCRP devices that feature similar technology and indications. The Agency believes it has identified all relevant risks to health (see section V of the 2013 proposed order) and that the mitigation methods described in the associated special controls guideline will be effective in mitigating these risks. These risks and mitigations were based on recommendations from the 1997 Panel and information provided by manufacturers in response to the section 515(i) of the FD&C Act call for information, which included information on preclinical testing and literature reports demonstrating that TMCRPs are effective for temporary reconstruction of the mandible and not associated with complications. FDA is also not precluded from requesting clinical data for TMCRP devices where it is necessary to demonstrate substantial equivalence. See section 513(a)(1)(B) of the FD&C Act.
The commenter also states that the new identification for this device is misleading and that the device should be limited to terminally ill patients who have had a tumor resection procedure. FDA disagrees with these comments. FDA believes the 1997 Panel did not intend to limit the use of TMCRP to terminally ill patients. FDA believes that the identified risks to health associated with TMCRP devices are inclusive for a patient population that has undergone resective surgical procedures, whether the result of a tumor or not, that requires the removal of the mandibular condyle and mandibular bone. Further, FDA believes that the identified special controls mitigate these risks and provide a reasonable assurance of safety and effectiveness in this patient population.
Under section 513(e) of the FD&C 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).
Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the devices. FDA has determined that premarket notification is necessary to provide reasonable assurance of safety and effectiveness of TMCRPs, and therefore, this device type is not exempt from premarket notification requirements.
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 Start Printed Page 79310guideline is also available at http://www.regulations.gov.
To receive “Temporary Mandibular Condyle Reconstruction Plate Class II Special Controls Guideline,” you may either send an email request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 301-847-8149 to receive a hard copy. Please use the document number 1799 to identify the guidance you are requesting.
This final order refers to currently approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 812 have been approved under OMB control number 0910-0078; the collections of information in part 807, subpart E, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 814, subpart B, have been approved under OMB control number 0910-0231; and the collections of information under 21 CFR part 801 have been approved under OMB control number 0910-0485.
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&C 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
3. Section 872.4770 is added to subpart E to read as follows:
§ 872.4770
(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.
[FR Doc. 2013-31217 Filed 12-27-13; 8:45 am]