April 17, Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852

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1 701 Pennsylvania Avenue, NW Suite 800 Washington, D.C Tel: Fax: April 17, 2018 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD Re: Docket FDA-2016-N-2378; Internal Review of s; Requests for of Certain s Made by the Center for Devices and Radiological Health Dear Sir or Madam: The Advanced Medical Technology Association (hereinafter referred to as AdvaMed ) is pleased to provide these comments regarding the Food and Drug Administration (FDA or Agency ) proposed rule on Internal Agency Review of s; Requests for Supervisory Review of Certain s Made by the Center for Devices and Radiological Health (CDRH). AdvaMed is the world s largest association representing manufacturers of medical devices, diagnostic products, and medical information systems. AdvaMed member companies produce technologies that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed s members produce nearly 90 percent of the health care technology purchased annually in the United States and more than 50 percent of such technology purchased annually around the world. AdvaMed members range from the largest to the smallest medical technology innovators and companies. Nearly 70 percent of our members have less than $30 million in annual sales. GENERAL COMMENTS The medical technology industry appreciates the efforts to develop this proposed rule, which helps provide clarity for both FDA and industry on the CDRH process for supervisory review of decisions along with binding deadlines for certain FDA actions related to supervisory review and other related timeframes. We also applaud improvements enacted in 21 st Cures related to this process, which include codification of documentation of least burdensome considerations in substantive summaries providing explanation of the rationale for 517A decisions. We believe supervisory review is a fundamental mechanism to support a transparent, timely, and fair dispute resolution process and are pleased to see coverage of decisions other than 517A decisions that are also critically important in the regulatory process. Through coverage of key decisions and timelines impacting manufacturers for Bringing innovation to patient care worldwide

2 Division of Dockets Management (HFA-305) April 17, 2018 Page 2 of 5 Docket FDA-2016-N-2378 purposes of internal agency supervisory review, understanding of the rationale for FDA decision making, predictable timeframes, appropriate and timely telescoping of review to those not involved in the issuing of the decision making and higher-level escalation as needed to ensure assessment at the appropriate level within the Agency (e.g., Center Director or Deputy Director level), and improved standardization of the appeals process, this process will be further efficient and effective to support U.S. public health and medical device innovation. We believe the proposed rule requires some clarification to ensure appropriate use of escalated review beyond the next organizational level above the decisionmaker and those involved in the decision as appropriate, sufficient scope for what are considered 517A decisions, and specific timelines for all covered FDA actions including non-517a decisions. AdvaMed greatly appreciates the opportunity to provide comments. Below are our specific comments to support improved clarity and practical implementation of the regulation to support improved efficiency and understanding of supervisory review. Our recommendations are included to assist FDA as it works to develop final rulemaking on these provisions of vital importance to the device appeals process. Sincerely, /s/ Khatereh Calleja Senior Vice President Technology and Regulatory Affairs

3 ADVAMED SPECIFIC COMMENTS AdvaMed Comments on Proposed Rule Requests for of Certain s Made by CDRH Edit Comment number Section Section of the guidance Change Proposed change to the guidance Comment/Rationale Reason for proposed change Edit Add the following: A grant or denial of CLIA Waiver ; A grant or denial of marketing authorization decision on de novo petition While the proposed list of 517A decisions appears intended to be examples ( includes one of the following decisions ), there should be explicit recognition of all significant decisions. Otherwise, there will be confusion and it will not meet objectives of the guidance for transparency and predictability in supervisory review of these key decisions. 1 Definition of Significant (a)(2) Granting of a de novo allows a device to be put on the market and is therefore a significant decision of the same gravity as the other decisions noted. CLIA waiver decisions also determine whether certain devices can be marketed to their intended users (e.g., designed and intended for physician office laboratories). Therefore, these decisions are also significant and should be designated as 517A decisions and subject to the specific referenced timelines. 2 Requests for ; Proposed Sequential Review (b)(1)(i) and Remove use of the term or sequential in the rule. Also clearly set forth that it may be permitted to request escalation to higher-level review (collapsing of two or more levels of review, which is otherwise referred to as telescoping ) to support assessment at the As FDA and industry would agree, internal Agency review is usually the quickest and most efficient means of formally resolving a dispute relating to a CDRH decision. On the other hand, the blanket proposal to require industry to exhaust every level of review in sequential order slows down the request process significantly and is more burdensome than what FDA currently requires (current Page 3 of 5

4 Edit appropriate level within the Agency (e.g., Center Director or Deputy Director level) even when a submitter has not yet exhausted other review options through the supervisory chain. Such consideration would take into account the nature of the request and the management level involved in the decision. Alternatively, revise preamble to state the following: In addition, absent adequate rationale, requesters should have exhausted review through the supervisory chain below the Center Director level prior to request for review at the Center Director level. FDA policy permits telescoping of review). This contradicts the proposed benefit of the rule to support efficiency in the appeals process in such codification. We are concerned that the proposed rule as drafted infers that a submitter may only request supervisory review at the next organizational level or higher above the individual who made the decision. While this may be unintended, this appears more limiting than the current appeals processes for such requests. As FDA itself has recognized, this decision might be based, for example, in matters pertaining to regulatory issues, new policy questions, or highly complex scientific questions. The rule should explicitly recognize such higher-level review where appropriate, which has been useful for the Agency and industry ranging from small to large company innovators. Appealing through the supervisory chain may not be appropriate in all cases and can add significant costs and delay access to new medical product innovation. 3 of 517A ; Substantive Summary of a 517A (b)(1) Clarify the timeframe for receipt of substantive summary for 517A decision from FDA, or at least allow further time for request of supervisory review (e.g., 5 business days following request for the substantive summary by submitter of their own device). It remains unclear when a company will receive a substantive summary of FDA scientific and regulatory rationale for decision on which the company can base an appeal. As the Food and Drug Administration Safety and Innovation Act (FDASIA) provided, substantive summaries must be provided by FDA upon request for 517A decisions. As FDA sets forth only 30 days to appeal a 517A decision, it is critical that such documentation of the significant decision, including significant controversies or differences of option and resolution of such controversies or differences, is provided to the company in a reasonable time period. As the documentation has to be in the record when the decision is made, FDA should be able to respond quickly to a company s request. Page 4 of 5

5 Edit 4 of Non-517A Revise deadline for request of supervisory review of non-517a decisions from 60 to 90 days. Alternatively, further explain what is meant by good cause to include issues impacting public health or other justifications. FDA has recommended that a request for appeal of a non- 517A decision be submitted within 60 days of the decision absent good cause. However, the preamble states that good cause relates to circumstances beyond the control of the submitter, such as snow emergency, Federal Government shutdown, or other unforeseen emergency event. It is possible to imagine, beyond time-impacting events like weather and shutdown, public health emergencies and other changes in circumstance that may warrant a good cause exception. Therefore, the deadline should be expanded to provide more time absent such narrow circumstances or minimally clarify that good cause can include public health or other appropriate justification. 5 Timeliness in Actions Related to of Non-517A Provide specific timelines for the following non-517 A decisions: 1) when CDRH will schedule a meeting or teleconference, if requested by the person requesting supervisory review (e.g., 30 days), and 2) for when CDRH will render a decision (e.g., 30 days or 45 days if no teleconference or meeting is requested). We appreciate CDRH inclusion of procedures for non- 517A decisions. At the same time, all supervisory decisions should be handled in an expedient manner. While we believe this is the Agency s intent and understand the need for the Agency to prioritize resources, it is critical to follow reasonable timeframes for any decision appealed to FDA. The proposed timeframes are similar to timeframes provided for 517A decisions and would support efficiency throughout the process and application of a least burdensome approach. We note currently the only timeframes provided for non- 517A decisions are those related to manufacturers; this should otherwise be removed if no timeframes for FDA actions are otherwise provided for these decisions. Page 5 of 5