Source: https://www.federalregister.gov/articles/2013/01/18/2013-01006/effective-date-of-requirement-for-premarket-approval-for-two-class-iii-preamendments-devices
Timestamp: 2014-04-16 21:59:51
Document Index: 618961269

Matched Legal Cases: ['art 812', 'art 812', '§ 812', '§ 812', '§ 812', '§ 860', '§ 860', 'art 814', 'art 807', '§ 888', '§ 888']

Federal Register | Effective Date of Requirement for Premarket Approval for Two Class III Preamendments Devices
Dates: Submit either electronic or written comments on the proposed order by April 18, 2013. FDA intends that, if a final order based on this proposed order is issued, anyone who wishes to continue to market the device will need to file a PMA or a notice of completion of a PDP within 90 days of the publication of the final order. See section X of this document for the proposed effective date of a final order based on this proposed order.
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Shorter URL: https://federalregister.gov/a/2013-01006 Related Topics
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The Federal Food, Drug, and Cosmetic Act (the FD Act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (94), the Safe Medical Devices Act of 1990 (the SMDA) (101), the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115), the Medical Device User Fee and Modernization Act of 2002 (Pub. L. 107-250), the Medical Devices Technical Corrections Act (Pub. L. 108-214), the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85), and the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144), among other amendments, establish a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD Act (21 U.S.C. 360c) established three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).
A preamendments device that has been classified into class III and devices found substantially equivalent by means of premarket notification (510(k)) procedures to such a preamendments device or to a device within that type (both the preamendments and substantially equivalent devices are referred to as preamendments class III devices) may be marketed without submission of a PMA until FDA issues a final order under section 515(b) of the FD Act (21 U.S.C. 360e(b)) requiring premarket approval. Section 515(b)(1) of the FD Act directs FDA to issue an order requiring premarket approval for a preamendments class III device.
Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed order, consideration of any comments received, and a meeting of a device classification panel described in section 513(b) of the FD&C Act, issue a final order to require premarket approval or publish a document terminating the proceeding together with the reasons for such termination. If FDA terminates the proceeding, FDA is required to initiate reclassification of the device under section 513(e) of the FD Act, unless the reason for termination is that the device is a banned device under section 516 of the FD Act (21 U.S.C. 360f).
A preamendments class III device may be commercially distributed without a PMA or a notice of completion of a PDP until 90 days after FDA issues a final order (a final rule issued under section 515(b) of the FD Act prior to the enactment of FDASIA is considered to be a final order for purposes of section 501(f) of the FD Act (21 U.S.C. 351(f))) requiring premarket approval for the device, or 30 months after final classification of the device under section 513 of the FD Act, whichever is later. For metal/metal hip systems, the preamendments class III devices that are the subject of this proposal, the later of these two time periods is the 90-day period. Since these devices were classified in 1987, the 30-month period has expired (52 FR 33686 at 33706, September 4, 1987). Therefore, if the proposal to require premarket approval for metal/metal hip systems is finalized, section 501(f)(2)(B) of the FD Act requires that a PMA or a notice of completion of a PDP for such device be filed within 90 days of the date of issuance of the final order. If a PMA or notice of completion of a PDP is not filed for such device within 90 days after the issuance of a final order, the device would be deemed adulterated under section 501(f) of the FD Act.
Also, a preamendments device subject to the order process under section 515(b) of the FD Act is not required to have an approved investigational device exemption (IDE) (see part 812 (21 CFR part 812)) contemporaneous with its interstate distribution until the date identified by FDA in the final order requiring the filing of a PMA for the device. At that time, an IDE is required only if a PMA or notice of completion of a PDP has not been filed. If the manufacturer, importer, or other sponsor of the device submits an IDE application and FDA approves it, the device may be distributed for investigational use. If a PMA or notice of completion of a PDP is not filed by the later of the two dates, and the device is not distributed for investigational use under an IDE, the device is deemed to be adulterated within the meaning of section 501(f)(1)(A) of the FD Act, and subject to seizure and condemnation under section 304 of the FD Act (21 U.S.C. 334) if its distribution continues. Other enforcement actions include, but are not limited to, the following: Shipment of devices in interstate commerce will be subject to injunction under section 302 of the FD Act (21 U.S.C. 332), and the individuals responsible for such shipment will be subject to prosecution under section 303 of the FD Act (21 U.S.C. 333). In the past, FDA has requested that manufacturers take action to prevent the further use of devices for which no PMA or notice of completion of a PDP has been filed and may determine that such a request is appropriate for the class III devices that are the subject of this proposed order, if finalized.
FDA intends that under § 812.2(d), the publication in the Federal Register of any final order based on this proposal will include a statement that, as of the date on which a PMA or a notice of completion of a PDP is required to be filed, the exemptions from the requirements of the IDE regulations for preamendments class III devices in § 812.2(c)(1) and (c)(2) will cease to apply to any device that is: (1) Not legally on the market on or before that date, or (2) legally on the market on or before that date but for which a PMA or notice of completion of a PDP is not filed by that date, or for which PMA approval has been denied or withdrawn.
If a PMA or notice of completion of a PDP for a class III device is not filed with FDA within 90 days after the date of issuance of any final order requiring premarket approval for the device, the device would be deemed adulterated under section 501(f) of the FD&C Act. The device may be distributed for investigational use only if the requirements of the IDE regulations are met. The requirements for significant risk devices include submitting an IDE application to FDA for review and approval. An approved IDE is required to be in effect before an investigation of the device may be initiated or continued under § 812.30. FDA, therefore, recommends that IDE applications be submitted to FDA at least 30 days before the end of the 90-day period after the issuance of the final order to avoid interrupting any ongoing investigations.
A hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (21 CFR 888.3027).
b. Adverse tissue reaction. Inadequate biological or mechanical properties of the device or its breakdown products, such as its lack of biocompatibility, may result in an adverse tissue reaction due to dissolution or wearing away of the articulating surfaces of the device and the release of materials from the device to the surrounding tissues and the systemic circulation.
In December 2011, AAOS published “Modern Metal-on-Metal Hip Implants: A Technology Overview” (Ref. 4). The AAOS overview provides a summary of clinical outcomes in patients with metal/metal hip systems in comparison to other bearing surface combinations, addresses patient, implant and surgical factors that may predict successful and unsuccessful outcomes of metal/metal hip systems and discusses the prevalence of adverse clinical problems from metal/metal hip systems in comparison to other bearing surface combinations. The report concludes that “analyses conducted on objective patient-oriented outcomes by two joint registries indicate that, overall, patients who receive metal-on-metal total hip arthroplasty and hip resurfacing are at greater risk for revision than patients who receive total hip arthroplasty using a different bearing surface combination.” The report references the aforementioned Australian registry. A recent article published in a scientific journal raised serious concerns about the failure rates of metal/metal hip systems for the UK population (Ref. 5). This peer-reviewed journal article presented the following findings regarding primary metal/metal total hip replacements: (1) Increased failure rate at 5 years for metal/metal total hip replacements related to larger head sizes; (2) significantly higher risk for revision in female patients (Note: In the United States, labeling includes warnings to discourage the use of metal/metal total hip replacements in females of child bearing age); and (3) revisions for dislocation in men with metal/metal hip replacements were slightly lower, showing some benefit to larger head sizes.
A PMA must include valid scientific evidence to demonstrate reasonable assurance of the safety and effectiveness of the device for its intended use (see § 860.7(c)(1) (21 CFR 860.7(c)(1))). Valid scientific evidence is “evidence from well-controlled investigations, partially controlled studies, studies and objective trials without matched controls, well-documented case histories conducted by qualified experts, and reports of significant human experience with a marketed device, from which it can fairly and responsibly be concluded by qualified experts that there is reasonable assurance of the safety and effectiveness of a device under its conditions of use * * *. Isolated case reports, random experience, reports lacking sufficient details to permit scientific evaluation, and unsubstantiated opinions are not regarded as valid scientific evidence to show safety or effectiveness.” (see § 860.7(c)(2)).
The collections of information in 21 CFR part 814 have been approved under OMB control number 0910-0231. The collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910-0120. The effect of this order, if finalized, is to shift certain devices from the 510(k) premarket notification process to the PMA process. To account for this change, FDA intends to transfer some of the burden from OMB control number 0910-0120, which is the control number for the 510(k) premarket notification process, to OMB control number 0910-0231, which is the control number for the PMA process. FDA estimates that it will receive seven new PMAs as a result of this order, if finalized. Based on FDA's most recent estimates, this will result in a 2,421 hour burden increase. FDA also estimates that there will be seven fewer 510(k) submissions as a result of this order, if finalized. Based on FDA's most recent estimates, this will result in a 318 hour burden decrease. Therefore, on net, FDA expects a burden hour increase of 2,103 due to this proposed regulatory change.
X. Proposed Effective Date Back to Top
XI. Comments Back to Top
2. Tower, S. S., “Arthroprosthetic Cobaltism: Neurological and Cardiac Manifestations in Two Patients with Metal-on-Metal Arthroplasty: A Case Report,”Journal of Bone and Joint Surgery, 92, 2847-2851, 2010.
5. A.J. Smith, et al., “Failure Rates of Stemmed Metal-on-Metal Hip Replacements: Analysis of Data From the National Joint Registry of England and Wales,”Lancet, 2012:S0140-6736(12)60353-5, March 13, 2012.
2.Section 888.3320 is amended by revising paragraph (c) to read as follows: § 888.3320 Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.
3.Section 888.3330 is amended by revising paragraph (c) to read as follows: § 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.