69 FR 162 pgs. 51765-51766 - Dental Devices; Dental Noble Metal Alloys and DentalBase Metal Alloys;Designation of Special Controls
Type: RULEVolume: 69Number: 162Pages: 51765 - 51766
Docket number: [Docket No. 2003N-0390]
FR document: [FR Doc. 04-19178 Filed 8-20-04; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMANSERVICES
Food and Drug Administration
21 CFR Part 872
[Docket No. 2003N-0390]
Dental Devices; Dental Noble Metal Alloys and DentalBase Metal Alloys;Designation of Special Controls
AGENCY:
Food and Drug Administration,HHS.
ACTION:
Final rule.
SUMMARY:
The Food and Drug Administration isamending the identification and classification regulations ofgold-based alloys and precious metal alloys for clinical use andbase alloys devices in order to designate a special control forthese devices. FDA is also exempting these devices frompremarket notification requirements. The agency is taking thisaction on its own initiative. This action is being taken underthe Federal Food, Drug, and Cosmetic Act (the act), as amended bythe Safe Medical Devices Act of 1990 (SMDA), and the Food andDrug Administration Modernization Act of 1997 (FDAMA). Elsewherein this issue of the Federal Register , FDA isannouncing the availability of the draft guidance documents thatwould serve as special controls for these devices.
DATES:
This rule is effective September 22, 2004.
FOR FURTHER INFORMATION CONTACT:
Michael E.Adjodha, Center for Devices and Radiological Health(HFZ-480), Food and Drug Administration, 9200 CorporateBlvd., Rockville, MD 20850, 301-827-5283, ext.123,e-mail: mea@cdrh.fda.gov .
SUPPLEMENTARY INFORMATION:
I. Background
The act (21 U.S.C. 301 et seq. ), as amended bythe Medical Devices Amendments of 1976 (the 1976 amendments)(Public Law 94-295), the SMDA (Public Law 101-629),and FDAMA (Public Law 105-115), established a comprehensivesystem for the regulation of medical devices intended for humanuse. Section 513 of the act (21 U.S.C. 360c) established threecategories (classes) of devices, depending on the regulatorycontrols needed to provide reasonable assurance of their safetyand effectiveness. The three categories of devices are asfollows: Class I (general controls), Class II (specialcontrols), and Class III (premarket approval).
Under section 513 of the act, FDA refers to devices that werein commercial distribution before May 28, 1976 (the date ofenactment of the 1976 amendments), as preamendments devices.Under the 1976 amendments, class II devices are identified asthose devices in which general controls by themselves areinsufficient to provide reasonable assurance of safety andeffectiveness of the device, but for which there is sufficientinformation to establish a performance standard to provide suchassurance.
The SMDA broadened the definition of class II devices toinclude those devices for which general controls would notprovide reasonable assurance of the safety and effectiveness, butfor which there is sufficient information to establish specialcontrols to provide such assurance. The special controls includeperformance standards, postmarket surveillance, patientregistries, development and dissemination of guidelines,recommendations, and any other appropriate actions the agencydeems necessary to provide such assurance. See section513(a)(1)(B) of the act.
FDAMA added, among other sections, a new section 510(m) to theact (21 U.S.C. 360(m)). Under new section 510(m) of the act, FDAmay exempt a class II device from premarket notificationrequirements (510(k)) (21 U.S.C. 360(k)), if the agencydetermines that premarket notification is not necessary to assurethe safety and effectiveness of the device.
In the Federal Register of December 1, 2003 (68FR 67097), FDA issued a proposed rule to amend the classificationregulation of gold-based alloys and precious metal alloys forclinical use and base metal alloy devices. FDA identified thedraft guidance documents entitled:"Class II SpecialControls Guidance Document: Dental Precious Metal Alloys"and "Class II Special Controls Document: Dental Base MetalAlloys" as the proposed special controls capable ofproviding reasonable assurance of the safety and effectiveness ofthese devices. FDA invited interested persons to comment on theproposed rule and the draft guidance documents by March 1, 2004.FDA received three comments.
II. Summary of Comments and FDA Response
FDA received one comment from a consumer and one (induplicate) from a trade association. Both comments were insupport of the proposed reclassification with minor modificationssuggested. The subject of the consumer comment was that the nameof the regulation "gold based alloys and precious metalalloys for clinical use" is unscientific since gold is, bydefinition, a precious metal.
FDA agrees that the name of the regulation is redundant and,accordingly, has changed the final rule to modify§ 872.3060 to read "noble metal," as theterm encompasses all precious metals such as gold. Thedescription "for clinical use" has been deletedbecause it is clear from the identification that such use isintended. For precision and clarity, we have also modified theidentifications in §§ 872.3060 and 872.3710 tomore precisely describe these alloys and their componentmetals.
The subject of the trade association comment was that: (1) Thescope of the dental base metal alloys guidance is not clear as towhat alloys are subject to the guidance and (2) therecommendation that the labeling for nickel-containing alloyscontain a contraindication for hypersensitive individuals isunnecessary because nickel has been demonstrated to bebiocompatible.
FDA agrees that more clarity is needed and has modified thescope of the guidance to define the devices not clearly addressedby the guidance. Regarding the second point, while FDA agreesthat nickel has been demonstrated to be biocompatible for thisintended use, FDA disagrees that the labeling should not containa contraindication for nickel hypersensitive individuals. Theagency believes this warning is needed to minimize the potentialfor adverse events associated with improper use of this device.Nickel, although biocompatible, is a known sensitizing agent fora small percentage of the population. FDA believes that removingthis warning will increase the risk of the device by potentiallyexposing nickel-hypersensitive individuals who, otherwise, wouldnot be exposed because of the current warning labels.
III. FDA's Conclusion
Based on the findings outlined in the preamble, FDA concludesthat special controls, in conjunction with general controls,provide reasonable assurance of the safety and effectiveness ofthese devices. FDA is designating the guidance documentsentitled: "Class II Special Controls Guidance Document:Dental Noble Metal Alloys" and "Class II SpecialControls Guidance Document: Dental Base Metal Alloys" asthe special controls that the agency believes will reasonablyassure the safety and effectiveness for noble metal alloys andbase metal alloys, respectively.
Following the effective date of the final rule exempting thedevice, manufacturers of these devices will need to address theissues covered in this special control guidance. However, themanufacturer need only show that its device meets therecommendations of the guidance or in some other way providesequivalent assurances of safety and effectiveness. Ifmanufacturers cannot comply with these recommendations orequivalent measures, they will not be exempt from therequirements of premarket notification and will need to submit apremarket notification and receive clearance for their deviceprior to marketing.
IV. Electronic Access
Persons with access to the Internet may access the Center forDevices and Radiological Health web site at http:///www.fda.gov/cdrh . A search capability for allCDRH documents is available at http://www.fda.gov/cdrh/guidances.html . Guidancedocuments are available on the Division of Dockets ManagementInternet site at http://www.fda.gov/ohrms/dockets .
V. Environmental Impact
The agency has determined under 21 CFR 25.34(b) that thisaction is of a type that does not individually or cumulativelyhave a significant effect on the human environmental. Therefore,neither an environmental assessment nor an environmental impactstatement is required.
VI. Analysis of Impacts
FDA has examined the impacts of the final rule under ExecutiveOrder 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 agenciesto assess all costs and benefits of available regulatoryalternatives and, when regulation is necessary, to selectregulatory approaches that maximize net benefits (includingpotential economic, environmental, public health and safety, andother advantages; distributive impacts; and equity). The agencybelieves that this final rule is not a significant regulatoryaction under the Executive order.
The Regulatory Flexibility Act requires agencies to analyzeregulatory options that would minimize any significant impact ofa rule on small entities. The purpose of this final rule is todesignate a special control for these devices. FDA has designatedguidance documents as the special controls. Becausemanufacturers, including small manufacturers, are alreadysubstantially in compliance with the recommendations in theguidance documents, and they will not add substantially to theinformation manufacturers presently submit, the agency certifiesthat the final rule will not have a significant economic impacton a substantial number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995requires that agencies prepare a written statement, whichincludes an assessment of anticipated costs and benefits, beforeproposing "any rule that includes any Federal mandate thatmay result in the expenditure by State, local, and tribalgovernments, in the aggregate, or by the private sector, of$100,000,000 or more (adjusted annually for inflation) in any oneyear." The current threshold after adjustment forinflation is $110,000,000 million. FDA does not expect thisfinal rule to result in any 1-year expenditure that would meet orexceed this amount.
VII. Federalism
FDA has analyzed this final rule in accordance with theprinciples set forth in Executive Order 13132. FDA hasdetermined that the rule does not contain policies that havesubstantial direct effects on the States, or on the distributionof power and responsibilities among the various levels ofgovernment. Accordingly, the agency has concluded that the ruledoes not contain policies that have federalism implications asdefined in the executive order and, consequently, a federalismsummary impact statement is not required.
VIII. Paperwork Reduction Act of 1995
This final rule contains no collections of information.Therefore, clearance by the Office of Management and Budget underthe Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520)is not required.
List of Subjects in 21 CFR Part 872
Medicaldevices.
Therefore, under the Federal Food, Drug, and Cosmetic Actand under authority delegated to the Commissioner of Food andDrugs, 21 CFR part 872 is amended as follows:
PART 872-DENTAL DEVICES
1. The authority citation for 21 CFR part 872 continues toread as follows:
Authority:
21 U.S.C. 351, 360, 360c, 360e,360j, 371.
2. Section 872.3060 andthe section heading are revised to read as follows:
§ 872.3060 Noblemetal alloy.
(a) Identification . A noble metal alloy is adevice composed primarily of noble metals, such as gold,palladium, platinum, or silver, that is intended for use in thefabrication of cast or porcelain-fused-to-metal crown and bridgerestorations.
(b) Classification . Class II (specialcontrols). The special control for these devices is FDA's"Class II Special Controls Guidance Document: Dental NobleMetal Alloys." The devices are exempt from the premarketnotification procedures in subpart E of part 807 of this chaptersubject to the limitations in § 872.9. See§ 872.1(e) for availability of guidanceinformation.
3. Section 872.3710 isrevised to read as follows:
§ 872.3710 Basemetal alloy.
(a) Identification . A base metal alloy is adevice composed primarily of base metals, such as nickel,chromium, or cobalt, that is intended for use in fabrication ofcast or porcelain-fused-to-metal crown and bridgerestorations.
(b) Classification . Class II (special controls).The special control for this device is FDA's "Class IISpecial Controls Guidance Document: Dental Base MetalAlloys." The device is exempt from the premarketnotification procedures in subpart E of part 807 of this chaptersubject to the limitations in § 872.9. See§ 872.1(e) for availability of guidance information.
Dated: August 11, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-19178 Filed 8-20-04; 8:45 am]
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