Re: Docket No. FDA-2017-N-4180: Voluntary Medical Device Manufacturing and Product Quality Program

Transcription

1 701 Pennsylvania Avenue, NW Suite 800 Washington, D.C Tel: Fax: (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD Re: : Voluntary Medical Device Manufacturing and Product Quality Program Dear Sir/Madam: On behalf of the Advanced Medical Technology Association ( AdvaMed ), we are pleased to submit these comments in response to the Food and Drug Administration s ( FDA or Agency ) request for comments on the Voluntary Medical Device Manufacturing and Product Quality Program ( appraisal program ). AdvaMed is the world s largest association representing manufacturers of medical devices, diagnostic products, and medical technology. AdvaMed s member companies range from the largest to the smallest medical product innovators and manufacturers, with nearly 70 percent of our members generating less than $100 million in annual sales. AdvaMed's member companies produce innovations that are transforming health care through earlier disease detection, less invasive procedures, and more effective treatments. AdvaMed commends FDA on the appraisal program. The program reflects the Agency s use of innovative strategies to collaborate with stakeholders to improve medical device design and manufacturing quality and, by extension, patient health outcomes. AdvaMed shares FDA s view that device quality is distinct from, and goes beyond, compliance. While compliance involves meeting baseline regulatory requirements, quality means continuous improvement to enhance device safety and effectiveness, with patient benefit as the orienting principle. AdvaMed supports the appraisal program and hopes that it will succeed in its pilot stage and transition to a fully-deployed program. To that end, AdvaMed has identified several areas where the appraisal program might be improved. Taken as a whole, these improvements call for greater transparency, specificity, consistency, and certainty. These requirements apply in the time before pilot launch, throughout the pilot program, and during the transition period should the appraisal program become a fully-deployed program. Transparency and specificity work together and require FDA to provide full and detailed information to prospective and actual participants, as well as interested stakeholders (e.g., device purchasers, payers, healthcare providers, and patients), about the appraisal program s operation. This includes the risks and benefits of participation; the factors included in the Bringing innovation to patient care worldwide

2 Page 2 of 12 appraisers review; how appraisers calculate their findings; how quality maturity is checked and tracked over time; the metrics that FDA will use to evaluate participant progress and program success; and the information that FDA will share with program participants and the public. Transparency and specificity likewise require FDA to share the factors that it will use to decide whether to transition the appraisal program to a fully-deployed initiative and how and when such a transition will occur. Consistency means the application of equivalent factors in appraising participants quality maturity. While the appraisal program must include different-sized firms that produce different kinds of devices, these differences cannot rationalize inconsistent appraisals of the firms quality maturity. Indeed, to reliably measure participants individual performance, performance in relation to other participants, and overall program success, FDA must apply a clearly defined and consistent appraisal framework. Certainty requires clear and correct understanding by participants and interested stakeholders of which appraisal program practices apply and when they apply. Consistency also requires clear and correct understanding of the conditions in which appraisal program practices might vary. The same criteria apply to program benefits: what benefits will participants receive, when will they receive those benefits, and under what circumstances might benefits vary or become unavailable. All of these criteria transparency, specificity, consistency, and certainty apply in the period preceding the appraisal program s launch, while the appraisal program is underway and, if appropriate, while it transitions to a full-time program. We have organized our comments according to this staged framework. There are opportunities for FDA to enhance the appraisal program pre-launch. Topic: FDA should provide greater transparency about the appraisal process. Discussion: AdvaMed believes that the appraisal program supports FDA s and the medical device industry s shared goal of enhancing medical device quality. But we are concerned about a lack of transparency into how appraisals occur and how appraisal results are determined. This opacity may inhibit device manufacturers from joining the appraisal program. To feel comfortable about the appraisal program, manufacturers must understand critical information about its operation. This information falls into three distinct areas: The activities evaluated: manufacturers must understand which of their design, manufacturing, and other production processes will be appraised. They must also understand how third-party appraisers will select those processes, the influence manufacturers have in process selection, and how third-party appraisers factor process evaluation into the quality maturity report. Personnel interviewed: manufacturers must understand who within their organizations the appraisers will select for interviews. Manufacturers likewise should

3 Page 3 of 12 understand the types of questions that these interviewees will be asked, as well as how appraisers will use their responses to inform the quality maturity report. Documents to be produced: manufacturers need a clear view of the documents that the appraisers will review. As with process evaluation and interviews, manufacturers should understand how appraisers will evaluate these documents and use them to develop the quality maturity report. Manufacturers additionally need greater transparency into the algorithm that the third-party appraisers use to formulate the quality maturity report. FDA has stated that process evaluation, interviews, and document review factor into the calculation, but the specific steps used to calculate and arrive at overall assessments have not been disclosed. It is also unclear what opportunities manufacturers have to discuss the quality maturity appraisal with third-party appraisers before they finalize the quality maturity report, and what influence manufacturer input might have on the report. Similar questions apply to the periodic check-ins between manufacturers and third-party appraisers. FDA has disclosed that these check-ins may occur quarterly or semi-annually. The Agency should further disclose what determines the frequency. Manufacturers need better understanding of the information that they must provide before and during check-ins. For example, will there be interviews, additional process assessments, or document review? As important, manufacturers must understand how third-party appraisers will evaluate such inputs to decide whether manufacturers are making quality gains. FDA has advised that, in some circumstances, third-party appraisers may update quality maturity appraisals following a check-in. Manufacturers must better understand the circumstances under which such updates will occur and the factors and formulas that appraisers use to decide whether to update a quality maturity finding. Manufacturers are unclear whether, over time, self-appraisal and reporting might replace appraiser-led check-ins. FDA should clarify whether transitioning to self-appraisal is possible and, if so, whether manufacturer-appraisers will require Capability Maturity Model Integration (CMMI) Institute training and certification. AdvaMed commends the FDA for its work so far to explain the appraisal program. The Federal Register notice announcing the October 10, 2017, appraisal program public workshop ( October 10, 2017, public workshop ), the workshop itself, and FDA staff s willingness to meet with interested stakeholders all reflect this effort. But the information provided in these forums does not afford sufficient transparency into the appraisal program. For example, the Federal Register notice advises that the appraiser would evaluate the firm s quality system maturity and manufacturing processes, and identify any gaps or where a participating firm is performing above a compliance baseline.... Conducting independent assessments using a maturity model is intended to be a driver of continuous process and product improvements and business value.... Voluntary Medical Device

4 Page 4 of 12 Manufacturing and Product Quality Program; Public Workshop; Request for Comments, 82 Fed. Reg. 141, p (July 25, 2017). While this passage offers an overview of where appraisers will focus and the benefits of program participation, details about how appraisers will engage onsite who they will talk to, what they will look at, how they will make their assessment and how this engagement will drive process and product improvement are absent. The CMMI Institute s presentation during the October 10, 2017, public workshop dives deeper into the appraisal process, but even this presentation does not offer a full picture. For example, while the presentation discloses heat map categories such as Estimating, Monitoring and Control, and Configuration Management, there was no explanation of what these categories mean or how appraisers assign ratings to them. Likewise, while the presentation explained that firms could be rated Satisfied, Partial, or Deficient in these and other categories, it is unclear what a firm must do to earn a Satisfied rating or the difference between a Partial and Deficient rating. AdvaMed understands that, in inspections and other regulatory inquiries, FDA need not disclose its assessment criteria. But the appraisal program is not an inspection. Rather, it is a program through which manufacturers work voluntarily with FDA and third parties to enhance the manufacturers quality capability. Against that backdrop, there is value in transparently disclosing the factors to be appraised and the appraisal methodology. This open disclosure will encourage manufacturer participation and increase their success in the appraisal program. Resolution: FDA should disclose detailed information about the factors evaluated during the initial appraisal, check-ins, and follow-on appraisals. This information should include process assessment, interviewee selections, document review, and other factors that inform the appraisal. FDA additionally should disclose the assessment algorithm used to determine a participant s quality maturity. FDA should map the interactions between appraisers and program participants, including opportunities for participants to preview and comment on appraiser findings. This information should be available in a single location, for example in a program manual posted on FDA s website. In developing this manual, FDA might interview prospective participants and other stakeholders to identify the information that they consider most critical. AdvaMed is happy to identify participants for these discussions and to serve as a thought partner in developing the program manual. FDA might also conduct informational meetings with prospective participants. These meetings could provide a chance for firms that have read the program manual to raise questions and concerns. The resulting dialogue would allow FDA to show its commitment to use the appraisal program as a voluntary and collaborative effort to build manufacturer quality. This, in turn, would increase manufacturer confidence and program participation. Topic: FDA should provide specific, transparent information about appraisal program costs.

5 Page 5 of 12 Discussion: The lack of clear and predictable information about all costs to participate in the appraisal program may hamper participation. This concern applies both to the number of firms that join the program and the distribution of firms from small to large. During the October 10, 2017, public workshop, the CMMI Institute estimated the cost of the initial appraisal from $25 thousand to $35 thousand, while other sources later estimated the cost at $17 thousand to $35 thousand. Large medical device manufacturers may be able to afford this cost, but these firms still must understand what their specific costs will be and how those costs are calculated. Likewise, firms must understand the specific costs for periodic check-ins and subsequent annual appraisals. Absent complete and accurate information about initial and carrying costs, appraisal program champions may not be able to generate support and funding from senior decision makers. Smaller firms face similar cost questions, and because these firms often manage tightly-constrained budgets, the answers are especially critical. The CMMI Institute stated at the October 10, 2017, public workshop that it will work with smaller manufacturers to reduce program participation costs, but there is no indication of which manufacturers qualify for cost reductions, to what extent costs will be reduced, whether costs will be reduced by "light" appraisals of small manufacturers, and what differences will exist between light appraisals and fully-loaded reviews. Furthermore, it is unclear whether a light, less-expensive appraisal will produce a quality maturity report that is substantively equivalent to the report for firms that undergo full appraisal. Concerns about differentiated appraisals might undermine confidence in firm-specific and cross-cutting performance results. Resolution: FDA should provide full transparency about appraisal program costs, including the costs of initial and follow-on appraisals, periodic check-ins, and other program costs. FDA should likewise disclose any cost-related differences in appraisals, check-ins, and other program elements, as well as how these differences do or do not affect quality maturity reports. These disclosures will demystify the appraisal process and create confidence that the program s quality analysis and maturity assessment is not cost-dependent. Topic: FDA should further develop and communicate the benefits of appraisal program participation. Description: FDA has clearly considered the need for benefits to appraisal program participants. As important, the Agency has clarified and communicated a number of these benefits, such as removal of participating sites from the Agency s surveillance inspection inventory. But there are other benefits that require further development and clarification. These include quantitative estimates of the inspection-related costs that program participants avoid, as well as the advantages to firms that bring their products to market via premarket approval applications (PMAs). Clarity about these benefits and further development of PMA benefits like handling of 30-day notices will increase interest and participation in the appraisal program. Resolution: FDA should prepare a brief document that details direct and indirect inspection costs that companies avoid when the Agency removes participating sites from its surveillance inspection inventory. Direct costs include not just the staff time and resources expended in

6 Page 6 of 12 inspection handling, but also follow-on costs, such as the expense of developing and implementing responses to inspection observations. Indirect costs relate to lost opportunities to deploy staff and resources towards product development, improvement, and market introduction, as well as process-efficiency gains, because those staff and resources are tied up in inspections. Source materials for cost identification might include the inspection-related costs detailed by participants in the October 10, 2017, public workshop. Similarly, FDA should clarify the benefits afforded to appraisal program participants. FDA has explained the PMA-related benefits that it is considering: limited manufacturing sections in PMA submissions and no preapproval inspection, streamlined site-change submissions, and simplified 30-day notice submissions with expedited review, for example. FDA should detail what these benefits encompass, when they will apply, and any conditions that limit their application. In particular, FDA should eliminate the need for 30-day notice submissions for pilot participants, allowing the participants instead to include these changes in annual reports. FDA has promised expedited handling of 30-day notices, but this commitment leaves important concerns unresolved. Even with expedited review and a streamlined template, there is no guarantee of acceptance of 30-day submissions. In cases where the streamlined notices are rejected, would the FDA then require a full, traditional 30-day notice? Or would the Agency convert the notice to a 135-day supplement, with the attendant time and expense? Eliminating the 30-day notice requirement in favor of annual reporting resolves this uncertainty and encourages program participation. Similarly, FDA should clarify its handling of site-change submissions from appraisal program participants. The Agency has proposed expedited handling of submissions via a simple template and a one-week review cycle. But this leaves important concerns unresolved. Would all site changes e.g., those identified in the October 21, 2015, draft guidance, Manufacturing Site Change Supplements: Content and Submission be eligible for expedited review? And if FDA rejects a submission, would the Agency then require a full 180-day supplement? Further clarity about the scope and conditions of the streamlined site-change process would resolve uncertainty and encourage program participation. At minimum, should FDA decline to make these proposed changes and clarifications, the Agency should track and report how many 30-day notice and site-change submissions exceed the expedited timelines and how many submissions are converted to 135-day and 180-day reviews. Topic: FDA should provide greater clarity about how its quality and compliance initiatives overlap. Description: Initiatives like the appraisal program assure that patients receive safe, effective, high-quality, and often innovative technologies, while reducing regulatory burdens. FDA has several such quality and compliance initiatives underway, which complement but sometimes overlap each other. For example, FDA s Premarket Approval Application Critical to Quality (CtQ) pilot program and the Digital Health Software Precertification (PreCert) Program share the appraisal program s use of alternate regulatory methods to enhance device quality.

7 Page 7 of 12 FDA s Medical Device Single Audit Program (MDSAP) likewise intersects the appraisal program, both through participants ability to use MDSAP to satisfy the appraisal program s prior-inspection requirement and the improvement in quality performance at appraisal program facilities, which are then inspected by MDSAP auditors. This overlap, while leveraging benefits and learning across programs, can challenge firms that are deciding whether to join one or more of these programs. For example, a firm deciding between the CtQ pilot program and the appraisal program may not understand the respective costs and benefits of these programs or how to use activities completed in one program to satisfy requirements in the other. Likewise, a firm may not understand how the practices reviewed in the Digital Health Software Precert Program might be evaluated in the appraisal program. This confusion and uncertainty makes it difficult for firms to decide whether to join these quality initiatives and, if so, which ones to join. This, in turns, threatens program uptake. Resolution: FDA should clarify where there is overlap between the appraisal program and other Agency quality and compliance-based initiatives. In particular, FDA should explain how the benefits of participating in the appraisal program are reduced, enhanced, or otherwise affected by participation in other programs. FDA should likewise detail the costs of program participation and the different benefits that the programs afford. Finally, FDA should state whether there is a risk that participation in other programs could diminish the benefits of the appraisal program. Topic: FDA should develop and use a common vocabulary to describe the appraisal program. Description: AdvaMed hopes that the appraisal program will become a fully-deployed effort that informs device design and manufacturing practices, as well as purchaser, provider, and patient choices. But this evolution cannot occur if program participants and stakeholders are unclear about terminology, i.e., the meaning of program criteria, practices, evaluative factors, reporting methods, and other essential elements. For example, the appraisal program incorporates metrics to be selected, developed, and maintained by program participants. These participants and interested stakeholders must understand what metrics means and how appraisers will use metrics. Absent a well-developed, shared lexicon, the appraisal program risks stagnation because participants and other stakeholders may misunderstand the program s elements and leave the program. Resolution: FDA should develop and use clear and consistent terms that describe key program elements. These terms will allow participants, FDA, and interested stakeholders to understand the program through a common vocabulary. This shared understanding will enhance program support and expansion, and enhance the program s value proposition and sustainability. Creating this common vocabulary requires identification of key program terms, giving meaning to those terms, and deciding how, when, and by whom the terms will be shared. For example, before publically sharing program participant data, FDA might convene a stakeholder focus group to identify the terms that group members require to understand and

8 Page 8 of 12 use this data. Focus-group feedback would then drive selection and definition of key terms. AdvaMed is happy to identify participants for these discussions and to serve as a thought partner in developing critical terminology. Topic: FDA should develop and share consistent metrics that show the performance of participants in the appraisal program and the program s overall success. Discussion: At the heart of the appraisal program is the question of whether participants show quality improvements. The answer to this question likewise speaks to the program s overall success. But no matter the results, they must be quantified using clear, consistent, and well-defined metrics. These metrics relate first to appraisal program participants. Before the first appraisal begins, FDA should define and share the measures that it will use to gauge a firm s quality maturity and to determine how that maturity changes over time. FDA likewise should quantify in advance what it considers program success, e.g., x percent improvement across y firms within z months. Developing these measures offers multiple benefits. First, firms are more likely to participate if they know in advance the measures that FDA will apply to their operations and how the Agency will apply those measures. Second, advance definition and consistent use of metrics enhances the credibility of appraisal program results. Resolution: Before the appraisal program launches, FDA should develop and share a metrics set that applies to participant performance as well as the metrics that will gauge overall program success. AdvaMed further recommends that, pre-launch, FDA advise appraisal program participants and interested stakeholders about how it will use and share these metrics. Important considerations include which metrics the Agency will share in the aggregate; whether the Agency will share de-identified information about specific participants; how the Agency will display quality trends per participant and across participants; and whether the Agency will disclose the identity of participants that do and do not complete the appraisal program successfully. Further, if metrics differ between participants, then FDA should explain whether and how it will normalize these metrics. There are opportunities for FDA to enhance the appraisal program after it launches and, if appropriate, while it transitions to a fully-deployed program. Topic: FDA should expand the appraisal program to recruit participants who use 510(k) submissions to bring products to market. Description: FDA has identified important benefits that it will offer to appraisal program participants, such as removal of participating sites from FDA s surveillance inspection inventory. Going further, FDA has proposed limited manufacturing sections in PMA submissions and no preapproval inspection, streamlined site-change submissions, and simplified 30-day notice submissions with expedited review. The challenge with this latter group of benefits is that they help participants bring devices to market via PMAs, without affording similar benefits to firms that use 510(k) submissions. Indeed, most medical device manufacturers rely on 510(k)s, not PMAs, for market entry. For FDA to build a robust and representative pilot program, it must include manufacturers that use 510(k) submissions, which requires benefits that motivate these manufacturers to join the program.

9 Page 9 of 12 Resolution: FDA should add benefits to the appraisal program that simplify and streamline the 510(k) process. The Agency might do so by focusing on the premarket portion of the total product lifecycle. For example, firms using 510(k)s sometimes struggle to define the nonclinical and clinical data that accompany their submissions. Closer coordination with Agency review staff designed to define data parameters, sources, and timing (e.g., pre versus postmarket filing) would afford greater clarity. FDA might look to its recently published, Breakthrough Devices Program: Draft Guidance for Industry and Food and Drug Administration Staff, for additional examples of premarket support. FDA might also offer a streamlined review pathway for special 510(k) submissions and allow manufacturers to document appropriate quality system changes in letters to file for devices manufactured at assessed facilities. Taken together, these benefits might motivate firms that rely on the 510(k) process to join the appraisal program. Were FDA to extend these benefits to firms that rely on PMAs, it might increase participation in this cohort as well. Topic: FDA should open the appraisal program to participants with Official Action Indicated (OAI) inspection results and equivalent MDSAP nonconformity findings. Discussion: AdvaMed understands FDA s interest in beginning the appraisal program with participants with stable compliance profiles and then measuring these participants quality gains. This approach avoids the question of whether participants are simply closing compliance gaps, rather than accelerating quality maturity. But in excluding firms that select sites with OAI inspection classifications or equivalent MDSAP nonconformity findings, FDA is bypassing the group that arguably could benefit most from appraisal program participation. This principle likewise applies should FDA remove a participant from the appraisal program because of compliance problems. These firms require the intensive review and interaction with appraisers that program participation affords. Likewise, these firms require the chance to benchmark against program participants and learn from their experiences. Resolution: FDA should expand the appraisal program to allow OAI/significant nonconformity participants to join and to allow participants removed for changed compliance status to re-join. Admission or readmission could be subject to stricter criteria than the ones applied to participants with stable quality systems. For example, FDA could require these firms to document how their remediation included identification and application of class-leading practices. Such an approach might incentivize firms to rapidly close compliance gaps and move past compliance towards quality. Topic: FDA should assure accurate and consistent representations by appraisal program participants. Description: FDA noted during the October 10, 2017, public workshop that it will share de-identified data about appraisal program results once a representative sample size is achieved. This will afford program participants and other interested parties a broad view of appraisal results and other key data points. AdvaMed also understands that program participants have the discretion to disclose their own data, including appraisal results. But it is unclear how FDA will assure that program participants share their appraisal information

10 Page 10 of 12 accurately and consistently. A program participant that inaccurately or inconsistently discloses appraisal information could gain a competitive advantage over other program participants and over non-participant competitors. Resolution: To prevent this risk, FDA should provide clear guidance to appraisal program participants about accurate and consistent disclosure of their appraisal information. This guidance should include a warning that participants may be removed from the program based on false or misleading disclosures. Likewise, FDA should provide clear information about the appraisal program generally, and appraisal data specifically, to interested stakeholders such as device purchasers, healthcare providers, and patients. FDA might disclose this information in an online posting that explains the appraisal program s operation. Armed with this information, stakeholders would understand and, if appropriate, question the data shared by program participants. Topic: Accurate benchmarking requires a uniform set of evaluative factors. Discussion: AdvaMed agrees that benchmarking of participant appraisal outcomes is a valuable component of the appraisal program. This benchmarking includes a participant s appraisal results in comparison to de-identified results from other participants, as well as a de-identified view of all participants appraisal results both at initial appraisal and over time. After the appraisal program has matured and there is better understanding of and confidence in appraisal results this benchmarking might create positive competition around device manufacturers quality performance. For example, a participant might choose to share its appraisal results with current and prospective customers to differentiate itself from competitors. Or device purchasers might ask firms to provide appraisal results to inform their purchasing choices. In addition, a firm struggling with a quality competency might look to a firm that unmasked its positive appraisal results for insights on how to improve performance. In this way, device manufacturers set benchmarks and drive quality improvement as a complement to FDA and other stakeholders efforts. But for any of these outcomes to occur, benchmarking must be based on a uniform, equally-applicable set of evaluative factors, i.e., an apples-to-apples comparison. At the October 10, 2017, public workshop, the CMMI Institute reported that it would customize aspects of its appraisals to reflect individual participants products, size, and the processes selected for appraisal. CMMI staff also discussed lighter-touch appraisals for smaller firms to reduce the cost of participating in the appraisal program. Inasmuch as these approaches undercut a uniform and equal comparison of quality maturity across program participants, then they impede fair and useful benchmarking. Firms cannot reliably communicate their appraisal results to others, or drive their own quality-improvement efforts by identifying and learning from comparator firms, unless appraisal factors are cross-cutting and commonly applicable. Nor can medical device purchasers make informed choices among firms if the factors used to appraise those firms are subjective and variable. Resolution: To mitigate these concerns, FDA should apply equal and consistent factors in appraising quality maturity. These factors should not vary based on a firm s size, products,

11 Page 11 of 12 areas of appraisal, or other relevant features. If it is impossible to apply identical factors across all appraisals, then FDA should identify a core set of factors that apply in all cases, plus limited, variable factors that account for the firm under review. In this case, the assessment should generate weighted results so that a meaningful, cross-firm comparison based on common elements is possible. Topic: FDA should develop an adverse event response plan. Discussion: As the appraisal program progresses, a participant may experience an adverse event. For example, a participant might receive a complaint that it then submits to FDA as a medical device report, or a participant might conduct a recall of products manufactured at a site selected for appraisal. Critics of the appraisal program might use these events to argue that the program is ineffective. Response: FDA should counter these arguments by proactively documenting appraisal program successes. The Agency might highlight, for example, quality and patient-outcome improvements shown by reduced recalls across participating sites, lower medical device reporting rates in comparison to non-participating sites, and positive feedback from healthcare providers and patients. Going further, with the permission of the participant, FDA could identify quality gains at the site that experienced the adverse event, showing how these gains outweigh the adverse event and how they position the site to avoid future adverse events. Having cross-cutting and firm-specific information ready will position FDA to dispel arguments that adverse events at participating sites signal program flaws. Topic: FDA should develop a plan to transition the appraisal program to a fullydeployed program. Discussion: Assuming that the appraisal program is successful, FDA needs a plan to transition it to a fully-deployed program. Full-time deployment includes broad application to manufacturers that use PMAs and 510(k)s to bring medical devices to market, as well as to firms that want appraisals at multiple sites. AdvaMed understands that the appraisal program will generate substantial data and lessons learned, and we believe that these inputs should shape the transition plan. Moreover, because a full-time program likely will apply new strategies to maximize impact and avoid pitfalls discovered in the pilot phase, FDA should begin crafting the transition plan now. The success of this transition plan requires input from stakeholders including appraisal program participants, device purchasers, healthcare providers, patients, and other interested parties. Resolution: FDA should develop a plan to transition the appraisal program to a fully-deployed program. The transition plan should detail key program elements, incentives, performance measurement, stakeholder input opportunities, and how the full-time program intersects with other FDA compliance and quality initiatives. AdvaMed requests that FDA consult with the above-referenced stakeholders as it develops the transition plan and that it publish the plan in draft, with time and opportunity for public comment. In developing the transition plan, AdvaMed hopes that FDA will consider applicable comments in this submission. For example, the need for cost transparency and assurance that

12 Page 12 of 12 participants disclose only accurate and consistent information is as important to a fully-deployed program as it is to a pilot program. In addition: A fully-deployed program should allow appraisal across sites within the same firm. A fully-deployed program should include more meaningful incentives related to 510(k) submissions, such as allowing manufacturers to document appropriate quality system changes in letters to file for devices manufactured at assessed facilities. * * * AdvaMed thanks FDA for its consideration of these comments. Please do not hesitate to contact me at or ssilverman@advamed.org if you have any questions. Respectfully Submitted, /s/ Steve Silverman Vice President Technology & Regulatory Affairs