Source: https://www.federalregister.gov/documents/2011/07/27/2011-18957/effective-date-of-requirement-for-premarket-approval-for-an-implantable-pacemaker-pulse-generator
Timestamp: 2017-08-23 12:10:19
Document Index: 58063372

Matched Legal Cases: ['§\u2009860', '§\u2009860', 'art 812', 'art 807', 'art 814', 'art 801', '§\u2009870']

Federal Register :: Effective Date of Requirement for Premarket Approval for an Implantable Pacemaker Pulse Generator
A Proposed Rule by the Food and Drug Administration on 07/27/2011
Submit either electronic or written comments by October 25, 2011. Submit requests for a change in classification by August 11, 2011. FDA intends that, if a final rule based on this proposed rule is issued, anyone who wishes to continue to market the device will need to submit a PMA within 90 days of the effective date of the final rule. Please see section XIII of this document for the effective date of any final rule that may publish based on this proposal.
44872-44877 (6 pages)
FDA-2011-N-0522
IV. Device Subject to This Proposal—Implantable Pacemaker Pulse Generator (21 CFR 870.3610)
2. Improper Pacing Rate
4. Improper Sensing
5. Tissue Damage
6. Unintended Stimulation
7. Development of Pacemaker Syndrome
8. Other Complications
https://www.federalregister.gov/d/2011-18957 https://www.federalregister.gov/d/2011-18957
The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the class III preamendments device implantable pacemaker pulse generator. The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to meet the statute's approval requirements and the benefits to the public from the use of the device. In addition, FDA is announcing the opportunity for interested persons to request that the Agency change the classification of the aforementioned device based on new information. This action implements certain statutory requirements.
You may submit comments, identified by Docket No. FDA-2011-N-0522, by any of the following methods:Start Printed Page 44873
The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 94-295), the Safe Medical Devices Act of 1990 (the SMDA) (Pub. L. 101-629), and 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 of 2004 (Pub. L. 108-214), and the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85), establish a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C 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).
Section 515(b)(2)(B) of the FD&C Act provides that if FDA receives a request for a change in the classification of the device within 15 days of the publication of the notice, FDA shall, within 60 days of the publication of the notice, consult with the appropriate FDA advisory committee and publish a notice denying the request for change in reclassification or announcing its intent to initiate a proceeding to reclassify the device under section 513(e) of the FD&C Act.
Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed rule and consideration of any comments received, issue a final rule 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&C Act, unless the reason for termination is that the device is a banned device under section 516 of the FD&C Act (21 U.S.C. 360f).
If a proposed rule to require premarket approval for a preamendments device is finalized, section 501(f)(2)(B) of the FD&C Act (21 U.S.C. 351(f)(2)(B)) requires that a PMA or notice of completion of a PDP for any such device be filed within 90 days of the date of issuance of the final rule or 30 months after the final classification of the device under section 513 of the FD&C Act, whichever is later. If a PMA or notice of completion of a PDP is not filed by the later of the two dates, commercial distribution of the device is Start Printed Page 44874required to cease since the device would be deemed adulterated under section 501(f) of the FD&C Act.
The FD&C Act does not permit an extension of the 90-day period after issuance of a final rule within which an application or a notice is required to be filed. The House Report on the 1976 amendments states that: [t]he thirty month grace period afforded after classification of a device into class III * * * is sufficient time for manufacturers and importers to develop the data and conduct the investigations necessary to support an application for premarket approval (H. Rept. 94-853, 94th Cong., 2d sess. 42 (1976)).
As required by section 515(b) of the FD&C Act, FDA is publishing its proposed findings regarding: (1) The degree of risk of illness or injury designed to be eliminated or reduced by requiring that this device have an approved PMA or a declared completed PDP, and (2) the benefits to the public from the use of the device.
These findings are based on the reports and recommendations of the advisory committees (panels) for the classification of these devices along with information submitted in response to the 515(i) Order that published in the Federal Register of April 9, 2009 (74 FR 16214), and any additional information that FDA has encountered. Additional information regarding the risks as well as classification associated with these device types can be found in the following proposed and final rules published in the Federal Register on the following dates: March 9, 1979 (44 FR 13373); February 5, 1980 (45 FR 7907); and May 11, 1987 (52 FR 17736).
An implantable pacemaker pulse generator is a device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. The power supply may be a pacemaker battery although, as discussed in section X of this document, FDA has no record of the pacemaker battery ever being marketed. This device is used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders. This device may include triggered, inhibited, and asynchronous devices implanted in the human body.
The Cardiovascular Devices Panel recommended that the implantable pacemaker pulse generator (which includes the internal pacemaker battery) be classified into class III because the device is implanted and life-supporting and presented a potential unreasonable risk of illness or injury. The power supply may be a pacemaker battery although, as discussed under section X of this document, FDA has no record of the pacemaker battery ever being marketed. The panel indicated that Start Printed Page 44875although a proposed standard had been written, it did not cover all of the performance characteristics of the device and that this standard was not widely accepted. The panel indicated that general controls alone would not provide sufficient control over the performance characteristics of the device and that sufficient scientific and medical data did not exist to establish a complete standard to assure the safety and effectiveness of particular aspects of the device. Consequently, the panel believed that premarket approval was necessary to assure the safety and effectiveness of the device. FDA continues to agree with the panel's recommendation.
A failure of the electronic circuitry or early battery depletion can cause failure to pace the patient's heart. Failure to pace could result in a dangerously slow heart rate (or in extreme cases, no heart beat at all), which could result in weakness, dizziness, fainting or even death.
An electronic circuit failure or an inaccurate rate controller in the circuit can cause improper pacing rates, which could be too fast or too slow. Improper pacing rates may result in symptoms of fatigue, chest discomfort, shortness of breath, dizziness, or fainting.
A sensing failure of the pacemaker during vulnerable periods of the cardiac cycle can induce cardiac arrhythmias, in particular, dangerously fast arrhythmias. In this case, dangerously fast arrhythmias may lead to chest pain, shortness of breath, dizziness, fainting or even death.
Electromagnetic interference with pacemaker electronics, loose connections, or sensing circuitry failures may cause improper sensing by the pacemaker, which can lead to failure to pace, improper pacing cycle, and/or arrhythmias.
If the materials, surface finish, or cleanliness of this device are inadequate, tissue damage can occur.
Pacing pulses may stimulate unintended nerve or muscle, resulting in uncomfortable contractions of the chest wall muscles or of the diaphragm.
Pacemaker syndrome may result from suboptimal atrioventricular (AV) synchrony or AV dyssynchrony; this could cause an uncomfortable cardiac awareness including palpitations, fatigue, dizziness, shortness of breath and near-fainting.
Other risks of pacemaker implantation include infection, erosion, fibrotic tissue formation, body rejection phenomena, hematoma, myopotential sensing, and additional surgery for replacement. Risks are also associated with pacemaker lead implantation. These are not discussed in this document.
A PMA must include valid scientific evidence to demonstrate reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 CFR 860.7(c)(2)). 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.” (21 CFR 860.7(c)(2)).
A PDP for this device may be submitted in lieu of a PMA, and must follow the procedures outlined in section 515(f) of the FD&C Act. A PDP must provide: (1) A description of the device, (2) preclinical trial information (if any), (3) clinical trial information (if any), (4) a description of the manufacturing and processing of the device, (5) the labeling of the device, and (6) all other relevant information about the device. In addition, the PDP must include progress reports and records of the trials conducted under the protocol on the safety and effectiveness of the device for which the completed PDP is sought.
A request for a change in the classification of this device is to be in the form of a reclassification petition containing the information required by § 860.123 (21 CFR 860.123), including new information relevant to the classification of the device.
The Agency advises that to ensure timely filing of any such petition, any request should be submitted to the Division of Dockets Management (see ADDRESSES) and not to the address provided in § 860.123(b)(1). If a timely request for a change in the classification of these devices is submitted, the Agency will, within 60 days after receipt of the petition, and after consultation with the appropriate FDA resources, publish an order in the Federal Register that either denies the request or gives notice of its intent to initiate a change in the classification of the device in accordance with section Start Printed Page 44876513(e) of the FD&C Act and 21 CFR 860.130 of the regulations.
The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. There have been no 510(k) submissions for implantable pacemaker devices since 1999, there is no record of pacemaker batteries ever being marketed, and both of these devices are in a state of disuse. Accordingly, FDA has concluded that there is little or no interest in marketing these devices in the future. Therefore, the Agency proposes to certify that the proposed rule, if issued as a final rule, would not have a significant economic impact on a substantial number of small entities. We specifically request detailed comment regarding the appropriateness of our assumptions regarding the potential economic impact of this proposed rule.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $136 million, using the most current (2010) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this proposed rule to result in any 1-year expenditure that would meet or exceed this amount.
This proposed rule, if issued as a final rule, would be likely to have no significant impact. We base this determination on an analysis of our Registration and Listing, 510(k) and Premarket Approval Application (PMA) database information. There have been no 510(k) submissions for implantable pacemaker pulse generators since 1999, with the exception of one 510(k) submission cleared in 2001 that was erroneously coded as an implantable pacemaker pulse generator (product code DXY), but is actually for an external pacemaker and is being corrected. Current pacemakers have newer features and capabilities that have rendered them not substantially equivalent to the devices cleared under 510(k) prior to 1999, which are obsolete. Current pacemakers are marketed under a PMA; in some cases the product code DXY has been erroneously applied. In addition, there have been no valid 510(k) submissions for pacemaker batteries for implantable pacemakers, which also fall under the product code DSZ also under 21 CFR 870.3610. Two 510(k) submissions have been received for DSZ devices since 1976, but they are believed to be miscoded. The Agency has no record of pacemaker batteries ever being marketed.
This information is summarized in table 1 of this document.
510(k) or PMA?
Implantable Pacemaker Pulse Generator DXY Both 2011 1990s Yes.1
Pacemaker Battery DSZ 510(k) No Record No Record No.2
1 Implantable pacemaker pulse generators have been submitted as PMAs since the early 1980s. The product code DXY has been erroneously applied to many of these PMA products. The last 510(k) submission for a DXY device was cleared in 1999.
2 Pacemaker batteries are not separately marketed products. They are internal to implantable pacemakers.
This proposed rule 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 part 812 are currently approved under OMB Control No. 0910-0078; the collections of information in part 807, subpart E are currently approved under OMB Control No. 0910-0120; the collections of information in 21 CFR Part 814, subpart B are currently approved under OMB Control No. 0910-0231; and the collections of information under 21 CFR Part 801 are currently approved under OMB Control No. 0910-0485.Start Printed Page 44877
2. Section 870.3610 is amended by revising paragraphs (a) and (c) to read as follows:
§ 870.3610
Implantable pacemaker pulse generator.
(c) Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before [A DATE WILL BE ADDED 90 DAYS AFTER DATE OF PUBLICATION OF A FUTURE FINAL RULE IN THE FEDERAL REGISTER], for any implantable pacemaker pulse generator that was in commercial distribution before May 28, 1976, or that has, on or before [A DATE WILL BE ADDED 90 DAYS AFTER DATE OF PUBLICATION OF A FUTURE FINAL RULE IN THE FEDERAL REGISTER], been found to be substantially equivalent to any implantable pacemaker pulse generator that was in commercial distribution before May 28, 1976. Any other implantable pacemaker pulse generator shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
[FR Doc. 2011-18957 Filed 7-26-11; 8:45 am]