Docket No. FDA-2013-D-0114, Draft Guidance Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements

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1 One Boston Scientific Place Natick, MA (508) Tel (508) Fax May 20, 2013 Divisions of Docket Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD RE: Docket No. FDA-2013-D-0114, Draft Guidance Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements Dear Sir or Madam, Boston Scientific Corporation appreciates the opportunity to provide comments in response to the Food and Drug Administration ( FDA or the Agency ) Federal Register notice of February 22, 2013, announcing the availability of the draft guidance Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices. For more than 30 years, Boston Scientific has advanced the practice of less-invasive medicine by providing a broad and deep portfolio of innovative products, technologies and services across a wide range of medical specialties. Boston Scientific s products help physicians and other medical professionals improve their patients quality of life by providing alternatives to surgery. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. I. General comments Boston Scientific sincerely appreciates FDA s efforts in documenting its thinking and approach for distinguishing medical device recalls ( recalls ) from product enhancements ( enhancements ). Over the past few years, there have been instances of companies being asked to recall marketed product upon submission of a premarket notification ( 510(k) ), Premarket Approval Application ( PMA ) or PMA Supplement for what the companies considered to be a product enhancement. Having a framework that the Agency and industry can leverage to distinguish between recalls and enhancements will help ensure timely recalls when a recall is necessary, and avoid confusion or disagreement when one is not. The draft guidance document affords an opportunity for dialogue on such a framework, and for sharing our thoughts and comments.

2 We have spent much time with our colleagues within the company and through trade associations discussing this draft guidance document. We are struck by the fact that it seems to be generating a significant amount of debate and divergent conclusions, and therefore worry that the draft guidance document has not achieved its purpose in clarifying the difference between product enhancements and recalls. We believe that there are some underlying inconsistencies and oddities in existing regulatory language that may be driving the difficulty in explaining and/or understanding the difference between enhancements and recalls. II. Specific comments 1) 21 CFR 7 and 806 have different definitions for correction and removal Table 1 below provides a side-by-side comparison of the definitions of correction and removal as they appear in 21 CFR 7 and 806. Table 1 - Definitions of Correction and Removal Correction Correction means repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location. 21 CFR CFR Correction means the repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a device without its physical removal from its point of use to some other location. Removal Not defined in Sec. 7.3 Removal means the physical removal of a device from its point of use to some other location for repair, modification, adjustment, relabeling, destruction, or inspection. The definitions in 21 CFR differ from the definition in 21 CFR 7.3 by the addition of point of use to the definition in 21 CFR FDA published 21 CFR 7 in 1977, whereas 21 CFR 806 was published in Based on experience gleaned in the intervening two decades, FDA determined the addition of point of use brought further clarity to correction and removal. When manufacturers consider action against a product in the field, they determine reportability based on the requirements and criteria outlined in 21 CFR 806. Therefore, we believe that the definitions of correction and removal as provided in 21 CFR 806 are the ones to be used in the guidance document. At a minimum, the guidance document should acknowledge the difference between the definitions in the two sections, and should factor the concept of point of use in the determination of whether a device change is an enhancement or a recall. Page 2 of 10

3 1) The definitions of correction and removal should not include product enhancement (p. 3, ) First, we note that any change to a definition that appears in the Code of Federal Regulations ( CFR ) should be modified through appropriate notice of rulemaking and comments to update the definition in the regulations. Further, we believe that FDA s introduction of product enhancement in the definitions of correction and removal introduces conflicting definitions within the guidance document, and should be avoided. In its proposed revised definition of correction (p.3 of the draft guidance document), FDA adds the following: Depending on the circumstances involved, a correction can be a recall or product enhancement. By adding this language, FDA in effect equates recalls to product enhancements. This is because the definition of recalls includes corrections (or removals) and if the definition of corrections (or removals) includes product enhancements, then by inference, the definition of recalls includes product enhancements. This is contrary to FDA s definition of product enhancements that they are not recalls. In addition, correction and removal are most often used in a recall situation, and have come to bear a negative connotation, one that we do not believe should carry through to product enhancement. We believe that distinguishing between correction and product enhancement and eliminating any overlap between them will help reinforce the understanding that modifications undertaken to correct violative products are recalls, whereas product modifications undertaken as part of a firm s continuous improvement and sustaining engineering efforts are product enhancements, and not a recall. Therefore, for the reason outlined above, we respectfully request that the definitions of correction and removal not be modified and remain as they appear today in 21 CFR ) The starting point for FDA s analysis is too broad and should be narrowed In the guidance document, the starting point for the analysis to distinguish a recall from a product enhancement is whether a manufacturer is considering making a change to its device. We believe that this starting point is too broad, and appears to be inconsistent with the regulations at 21 CFR 7, and inconsistent with criteria outlined in 21 CFR CFR 7.3 defines recall as (emphasis added): Recall means a firm's removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the laws it administers and against Page 3 of 10

4 which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery. 21 CFR defines the scope of reporting for corrections and removals as follows (emphasis added): (a) This part implements the provisions of section 519(f) of the Federal Food, Drug, and Cosmetic Act (the act) requiring device manufacturers and importers to report promptly to the Food and Drug Administration (FDA) certain actions concerning device corrections and removals, and to maintain records of all corrections and removals regardless of whether such corrections and removals are required to be reported to FDA. (b) The following actions are exempt from the reporting requirements of this part: (1) Actions taken by device manufacturers or importers to improve the performance or quality of a device but that do not reduce a risk to health posed by the device or remedy a violation of the act caused by the device. (2) Market withdrawals as defined in 806.2(h). (3) Routine servicing as defined in 806.2(k). (4) Stock recoveries as defined in 806.2(l). Across the industry, there are thousands of changes that occur each year that are not made to reduce a risk to health or remedy a violation. Further, thousands of changes are implemented each year that are not undertaken to improve the performance or quality of a device, but rather, to address discontinued components, parts or materials. Examples are: - Changes to replace one obsolete component or part with an alternate component or part that meets the required specifications - Changes to replace one discontinued material with an alternate material that meets the required specifications - Changes driven by a company s cost improvement initiatives When any of the above changes are made absent any violations or risk to health, the manufacturer should not be required to evaluate these changes for a determination of enhancement vs. recall. To do so would be overly burdensome, resource intensive, and would introduce significant delays in a manufacturers routine operations. Finally, FDA does not include point of use in its decision-making process. Point of use was deliberately included in the definitions of correction and removal in 21 CFR 806. We believe that factoring in point of use will further narrow the scope of changes to be evaluated for a determination of enhancement or recall, because only those changes that affect product in point of use should be evaluated for a determination of enhancement vs. recall. No definition of point of use is provided in the regulations. We interpret product in point of use as product that has already left the manufacturer s control. Page 4 of 10

5 Therefore, we respectfully request that the flow and logic of the decision-making process be modified such that not all changes to devices have to be evaluated for a determination of enhancement vs. recall, as suggested in the draft guidance document. The modified flow should factor in whether the change is to a product in point of use or not, and whether the change is being considered as part of a planned action to remedy a product that is in violation of the laws FDA administers and against which FDA is likely to take legal action. From there, the determination of enhancement vs. recall can start. 3) Differentiating violative devices from non-violative devices (Section IV, page 5) We recommend adding a definition for violation or violative device, and propose the following definition, which closely mirrors the definition of Recall in 21 CFR 7(3)(g): For purposes of this guidance document, the use of violative device is considered to mean a marketed product that the Food and Drug administration considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Regarding the determination of whether a product is violative or not, FDA states (Section IV, page 5): A firm s risk management activities will help provide a reference for known failure modes and expected or estimated failure rates. An increase in overall failure rate, increase in a single failure mode rate, or the identification of a new failure mode would indicate a failure to perform as intended. A change to the marketed device to address a failure to perform to specifications, or a failure to perform as intended, would constitute a medical device recall. We propose replacing the above paragraph with the following: A firm s risk management activities will help provide a reference for known failure modes and expected or estimated failure rates. A significant increase in overall failure rate, significant increase in a single failure mode rate, or the identification of a new failure mode may indicate an unanticipated increase in risk, which must be evaluated to determine if the risk is clinically unacceptable and if the product is failing to perform as intended. Any change to the marketed device to mitigate unacceptable risk or address a failure to perform as intended, would constitute a medical device recall. Our rationale for the recommended change in wording is as follows: 1. The risk management activities of a medical device firm are typically aligned with ISO Through this process, product that is found to have increased risk is re-run through the risk assessment process including risk estimation and evaluation. The result Page 5 of 10

6 of risk evaluation can be either that a) the risk is clinically acceptable without any further change to the product, and the risk management file is updated or b) the risk is clinically unacceptable and risk control measures (additional mitigations) must be implemented. We believe that the guidance should focus on changes made to a marketed/distributed product once it is determined that a) the product is violative and b) the risk if left unmodified is unacceptable after applying ISO criteria. 2. Not meeting the previously documented risk level in the risk management file does not necessarily mean that the device fails to perform as intended. Individual and overall failure rates documented as part of a firms risk management activities are most often established as alert thresholds, not as alarm thresholds. Not meeting the previously documented risk level in the risk management file does trigger an investigation into the unanticipated risk to determine its acceptability through ISO risk management process to determine whether the device performance is acceptable 3. A risk management document, such as a hazard analysis, sets a level of risk that has been determined to be acceptable. Risk that is not documented in the risk management documentation or exceeds that documented does not imply that the risk is unacceptable. Per ISO (see Sections 6.6 and 9), this risk is analyzed, estimated, and evaluated for acceptability. Unanticipated risk does not imply unacceptable risk per ISO It is in a physician s and patient s best interest for a firm to set acceptable risk levels low (i.e., lower than what is clinically relevant) such that investigation is performed into root cause, determining acceptability of the risk with respect to the patient benefit, and determining if field action is required. 5. Many device specifications are not related to safety or effectiveness of the device. For example, specifications may be set to exceed the levels established in an international standard in order to provide an early manufacturing alert, or to standardize specifications of components across multiple products. 6. Product and data stabilization during the product launch period must be considered when making the evaluation. When a product is initially launched, expected failures may occur when the use denominator is still small, and may not necessarily be indicative of the steady state rate of failure, when the use denominator has stabilized. Regarding the failure to meet any specification (Section IV, page 5), we believe that FDA references the wrong section in referencing section 501(c) of the Federal Food, Drug, and Cosmetic Act. It appears that the Agency s intent is more relevant to sections 501(e) through (h). 4) Comment on example provided and need for additional examples The one example provided in the guidance document is a good example, but would benefit from clarification of what the labeled battery life is. For many devices, battery longevity varies, based on circuit current drain, exact patient usage, etc. Typically, labeling for the product will include an expected longevity that is the middle of the expected distribution. For example, AdvaMed Page 6 of 10

7 guidance for pacemakers and defibrillators considers a pacemaker or defibrillator that achieves 75% of expected longevity to be normal battery depletion. We also believe the guidance document would benefit from additional examples. 5) The proposed reporting of some product enhancements under 806 is contradictory to the legislative and regulatory intent of 21 CFR 806 The recommendation made by this guidance document to report certain product enhancements that are not recalls under 21 CFR 806 is unnecessary, burdensome, and fundamentally at odds with legislative intent and existing regulatory language. Regulatory and Legislative Background The scope of actions to be reported pursuant to 21 CFR 806 is well documented in the preamble to the final rule appearing in the Federal Register on May 19, The following discussion appears in the preamble to 21 CFR 806, clarifying the congressional intent for FD&C 519(f), and how the language in 21 CFR 806 was amended to reflect the balance depicted in the congressional records (emphasis added): Section 519(f) of the act was enacted because Congress was concerned that device manufacturers, distributors, and importers were carrying out product corrections or removals without notifying FDA, or without notifying the agency in a timely fashion (H. Rept. 808, 101st Cong., 2d sess. 29 (1990)). Congress explained that industry s failure to report corrections and removals, particularly those undertaken to reduce risks associated with the use of a device, denies the agency the opportunity to fulfill its public health responsibilities by evaluating device related problems and the adequacy of corrective actions (S. Rept. 513, 101 st Cong., 2d sess. 23 (1990)), and has seriously interfered with FDA s ability to take prompt action against potentially dangerous devices (H. Rept. 808, 101 st Cong., 2d sess. 29 (1990)). The agency recognizes that Congress did not want to overburden industry or FDA with excessive reporting requirements and that the reporting requirements apply to the more important postmarket actions, excluding those events already reported to the [agency]. (S. Rept. 513, 101st Cong., 2d sess. 23 (1990)). To ensure that FDA has access to all relevant information on corrections and removals, Congress provided that records be maintained for those corrections and removals that need not be reported. And, under Section II, Highlights of the final rule for 21 CFR 806 (emphasis added): The agency has revised and clarified certain provisions of the final regulation. Further, the agency has narrowed the scope of the regulation to focus more explicitly on those corrections and removals that address more serious risks to health. The most significant Page 7 of 10

8 changes from the March 23, 1994, proposed rule (59 FR 13828) to establish procedures to implement the reports of corrections and removals provisions of section 519(f) of the act (hereinafter referred to as the March 1994 proposed rule) follow: 1. The definition of risk to health has been narrowed by revising 806.2(j) to focus explicitly on those corrections and removals undertaken to mitigate the potential for adverse health consequences. The revised definition of risk to health tracks the definitions of class I and class II recall in 7.3(m) (21 CFR 7.3(m)). Finally, in introductory remarks to S. 3006, A bill to amend the Federal Food, Drug, and Cosmetic Act to make improvements in the regulation of medical devices, and for other purposes (8/4/1990, 101 st Congress), the following is stated (emphasis added): S responds directly to the lessons learned from implementing and enforcing the Amendments. Three themes dominate S. 3006: (1) enhancing the safety and effectiveness of devices by defining and better streamlining the premarket review mechanisms, and by creating a web of postmarket controls that alert the FDA to device problems and provide the means for responding quickly and effectively to situations that may present serious, adverse health consequences; (2) preserving and focusing FDA resources on the most important public health issues associated with medical device regulation; and (3) avoiding over-regulations, thus maintaining a highly competitive, innovative industry. S was a precursor to and is related to H.R. 3095, Safe Medical Devices Act of Throughout the legislative and regulatory processes, it is clear that the intent was to narrow the scope of reporting to focus on those corrections and removals that address the more serious risks to health. Redundancy with Existing Regulations There already are regulatory pathways for notifying FDA of changes that potentially affect the safety and effectiveness of a device. Any product enhancement to a class II medical device that is not violative, but could significantly affect the safety or effectiveness of the device is required to be submitted to FDA in a 510(k) premarket notification (21 CFR (3)(i)). Similarly, any product enhancement to a class III medical device that is not violative, but affects device safety or effectiveness is required to be submitted to FDA in a PMA Supplement (21 CFR (a)), unless the type of change is one that does not require a PMA Supplement per 21 CFR (e). The proposal in the draft guidance document to submit an 806 report for product enhancements that are not considered to be a recall but reduce a risk to health are redundant with the required submissions under 21 CFR 807 and 814, and should therefore not be required. Page 8 of 10

9 Recommendations Based on the above analysis of the legal and regulatory frameworks and the potential for redundant regulatory requirements, we recommend that the agency remove from the guidance document the requirement to report product enhancements under part 806. Further, should the agency wish to proceed with this proposal, we believe that such change first requires a corresponding amendment to the underlying regulations and therefore should be handled through rulemaking, not via a guidance document. 6) FDA s plan to determine the appropriate premarket and postmarket actions necessary to address the information contained in the 806 report exceeds the authorities provided under 806 and duplicate In section VI, page 12 of the proposed guidance document, FDA states: An 806 report submitted for product enhancements should be identified as such by the manufacturer. If FDA concurs with your assessment that the correction or removal is a product enhancement, the agency will not treat the report as a recall but will determine the appropriate premarket and postmarket actions necessary to address the information contained in the 806 report. Conflict with Existing Longstanding Discretion to the Manufacturer As noted in section 4, there already are pathways by which product modifications are to be reported to FDA. FDA has historically deferred to the manufacturer as the decision-maker as to whether a device enhancement triggers the need for a new submission. In fact, with respect to 510(k)s, FDA s own guidance states: FDA believes that the 510(k) holder is best qualified to determine when modifications to their device could significantly affect safety or effectiveness. Therefore, every modification to the device should be reviewed by appropriate personnel to determine if it affects safety or efficacy. Any design or labeling change to a device should be evaluated and documented in accordance with the 21 CFR 8203, Quality System regulation. If it is determined that the modification is not significant, the basis for this decision should be documented with supporting data in the 510(k) holder's device master file. If it is determined that the modification is significant, a new 510(k) must be submitted to FDA. 1 1 [U.S. Food and Drug Administration, Device Advice, Comprehensive Regulatory Assistance, Is a new 510(k) required for a modification to the device?, available at ns/premarketnotification510k/ucm htm, last updated 4/26/2009 (emphasis added)]. Page 9 of 10

10 Requiring companies to submit 806 reports for any modification that is intended to reduce a risk to health could lead to confusion or inconsistent application as between reporting under Part 807 and/or Part 806. There may be product enhancements that reduce a risk to health, but may not be considered a change that significantly affects safety and effectiveness. Whether this standard is met has historically been left to the 510(k) holder. Indeed, FDA has the authority to review 510(k) decisions made by the company during inspection. However, the guidance document seemingly takes a company s decision-making in this regard and turns it over to the agency. FDA s determination of the appropriate premarket and postmarket actions necessary to address the information contained in the 806 report conflicts with FDA s longstanding policy to defer to the 510(k) holder as to whether and how to notify FDA of device enhancements. We therefore disagree with the Agency s proposed approach as it is unnecessary and exceeds FDA s authority under 21 CFR As discussed above, the current pathways for assessing when to submit a 510(k) or PMA are already established (21 CFR , , and , primarily). We believe that the proposal to extend FDA s jurisdiction under 21 CFR 806 to include determination of premarket actions on product enhancements is duplicative, overly burdensome, and should be removed from the final guidance document. III. Conclusion In conclusion, we are very appreciative of this opportunity to review the guidance document and provide our comments. We incorporate by reference the comments submitted by AdvaMed, of which Boston Scientific is a member. Because of the significance of the changes being proposed, including changes that appear to warrant a notice of rulemaking, we hope that FDA will consider further consultation with the industry prior to issuing a document in final form. We are available to answer any questions FDA may have about our comments. We look forward to further collaboration on this important topic. Best regards, Tamima Itani, Ph.D., RAC, FRAPS Vice President, Global Regulatory Affairs and Regulatory Compliance Boston Scientific Corporation Tel: (508) tamima.itani@bsci.com Page 10 of 10