November 7, Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852
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1 1300 North 17 th Street Suite 1752 Arlington, Virginia Tel: Fax: November 7, 2011 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD RE: Docket No. FDA-2011-N-0648 Dear Sir/Madam: This letter represents the comments of the Medical Imaging & Technology Alliance (MITA) in response to the Notice of Availability of the draft standard operating procedures (SOPs), for a new Network of Experts, (Network), as announced in the Federal Register, 76 Federal Register 62072, October 6, These SOPs describe a new process for FDA to gain access to scientific, engineering and medical expertise when it is needed to supplement the existing sources of knowledge of Agency staff, and is particularly pertinent to new and emerging areas of science and engineering technologies. FDA s goal is to enable Agency staff to tap into external expertise within two weeks of defining a scientific question that needs to be dealt with quickly. MITA recognizes that it is a formidable challenge for FDA staff to possess specific expertise on the extensive range of medical technologies. MITA supports the Agency in its efforts to reach out to those professionals and organizations which have important knowledge on medical and scientific issues which pertain to the Agency s mission. We believe that these SOPs should be improved in a number of ways in the interest of improving the regulatory process. These improvements include ensuring that the expertise and experience of industry will also be sought on medical, scientific and engineering issues that affect regulatory decision making processes, and clarifying what the impacts of the use of these external experts will be on the 510(k) process. MITA will set forth its concerns and recommendations for improvement below. We appreciate the opportunity to share our views with the Agency. Our recommendations for improvement are as follows: FDA should allow industry to partner with the Agency in its Network of Experts program, by permitting it to contribute its own unique and valuable experience and expertise on medical device technology and development issues; 1
2 FDA should clarify and carefully consider what the impacts of instituting consultation with experts will be on the 510(k) review process, and the timeliness of FDA performance on the processing of premarket submissions; FDA should strengthen the enrollment of experts into the Network by clarifying the process by which outside organizations can proactively make FDA aware of their existence, and areas of expertise, and by providing a specific time limit by which the Agency will review the viability and effectiveness of these organizations; FDA should set time goals for the entire process of seeking expertise from the Network of Experts, beginning with and including the request by CDRH staff for external expertise to address a specific issue, and ending with the signoff and posting of the experts opinions on the Network of Experts Traction page for use throughout CDRH; and FDA should institute greater efficiencies on the management of Conflict of Interest (COI) and Conflict Disclosure Agreement (CDA) forms. MITA is the collective voice of medical imaging equipment manufacturers, innovators and product developers, which include the following medical imaging technologies: Medical X-ray equipment Computed tomography (CT) scanners Molecular imaging (including radiopharmaceuticals) Radiation therapy equipment Ultrasound Magnetic resonance imaging (MRI) Imaging information systems MITA Comments FDA should allow industry to partner with the Agency in its Network of Experts program, by permitting it to contribute its own unique and valuable experience and expertise on medical device technology and development issues In its SOP, CDRH states that, in solicitation of organizations from which it intends to seek expert knowledge, it aims to include a variety of viewpoints in the Network. Further, the Agency states that it will seek to give preference to organizations, such as 501(c)(3) organizations, and other non-profits, whose primary function is neither lobbying nor self-promotion. MITA believes that FDA s exclusive reliance upon the aforementioned types of organizations, as the only outside sources of scientific expertise, constitutes an overly narrow approach, and is inconsistent with its expressed intent to provide a variety of viewpoints in the Network of Experts program. Development of the Network of Experts Issue Outline is the first step in developing a request for expert information in the program. The SOP provides that in developing the Network of Experts Issue Outline, questions about a product line or specific medical indication may include specific questions related to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, 2
3 biocompatibility, standards and other characteristics as applicable. Manufacturers have the most experience in terms of research and development, design controls, production, and extensive testing and analysis related to their products, and are regulated by standards for compliance to such testing and analysis requirements. This experience and expertise cannot be obtained elsewhere. Therefore, it is important that industry organizations be allowed to partner with FDA, and permit qualified industry representatives to participate as external experts with respect to specific medical device technologies, as described in the SOPs. This is essential to ensure that FDA receives a balanced and fully informed understanding on these issues. MITA also recommends that FDA support regulatory or legislative changes, as appropriate, to enable industry participation in the Network of Experts. MITA requests that the FDA inform manufacturers when the Agency consults experts during the review of a 510(k) application, the basic information related to the questions asked, and the domain or expertise of the expert. In addition, MITA should be permitted to view the opinions provided by the expert. FDA should clarify and carefully consider what the impacts of instituting consultation with the Network of Experts will be on the 510(k) review process, and the timeliness of FDA performance on the processing of premarket submissions The SOP states that the Network may be used to address scientific questions such as those which occur during a premarket review, postmarket surveillance and product recalls. While MITA supports Agency consultation with experts, MITA is concerned what the impacts of such consultation may be on FDA regulatory processes. More specifically, MITA believes that the manufacturer should be informed if FDA requests an expert opinion during the review of a premarket application, or if the consultation provided by an expert will become a part of the application. The manufacturer should also have the opportunity to review and provide comment to FDA on the report of the expert. MITA requests that FDA carefully consider the impacts of instituting the Network of Experts program on its regulatory processes, and clearly communicate to stakeholders what the impacts will be, and how such impacts will be addressed, so that timely and efficient performance of Agency regulatory processes may be maintained. MITA is also concerned about the possible impact that soliciting of expert opinion will have on FDA development of guidance documents. Guidance documents have an essential, practical purpose. They are central to aiding the development of premarket submissions for review, and are intended to facilitate clearance of products to market. Timely issuance of guidance documents is important to maintaining an efficient flow of the regulatory process. FDA should clarify that obtaining input from experts will not adversely influence the development, issuance or content of existing or pending guidance documents. In addition, MITA believes that FDA should analyze and report on the frequency of Agency consultation with those experts in the Network with respect to review of 510(k) applications. FDA should define how the opinions provided by these experts will be evaluated, and what impacts they will have on the regulatory and review processes. 3
4 Finally, it is important to keep in mind that the Network of Experts program should not be considered as a substitute or replacement for education of FDA reviewers and staff on medical device technologies which are the subject of premarket submissions. The education of FDA reviewers for the purpose of improving the review of premarket applications is important in its own right and should be a continual and ongoing process. FDA should ensure that instituting a Network of Experts program for the solicitation of expert opinion on scientific, medical or engineering issues will be separate from, and not interfere with, the ongoing educational process for FDA reviewers and staff. FDA should strengthen the expert enrollment process by clarifying the process by which outside organizations can proactively make FDA aware of their existence and areas of expertise, and by providing a specific time limit by which it will review the viability and effectiveness of these organizations The SOP states that any member of the CDRH staff can nominate an organization for the Network of Experts by submitting the name of the organization, a brief description of its relevant expertise, and any known contact information to the Network of Experts coordinator. MITA believes that the SOP should also have a process in which an organization can proactively make the Agency aware of its existence and its relevant areas of expertise. This will help ensure that FDA does not inadvertently exclude potentially valuable sources of expert knowledge. The SOP provides that once an organization is selected for the Network by CDRH, agreements will be drafted and negotiated by technology staff in CDRH. In addition, once the agreement has been negotiated and executed, the organization will be deemed to be enrolled in the Network of Experts. In order to keep its Network current and effective, FDA should set a specific, periodic time period, perhaps every two years, in which it will review the viability and effectiveness of its partner organizations. This is needed in order to keep abreast of the continuous merger and dissolution of organizations, and any relevant changes in an organization s purpose or operations. FDA should set time goals for the entire process of seeking expertise from the Network of Experts, beginning with and including CDRH staff initiation of the process for the request for external expertise to address a specific issue, and ending with the signoff and posting of the experts opinions on the Network of Experts Traction page for use throughout CDRH The Network of Experts program is intended to follow the following process: 1. The CDRH staff will provide a brief description to their appropriate Branch Chief of the issues which they believe require external expertise, in the form of a Network of Experts Issue Outline ; 2. The Branch Chief will review and, if warranted in his or her judgement, clear the request; 3. The Network of Experts coordinator will send requests to Network organizations for experts with relevant expertise; 4. Experts will be screened and selected, and then asked to provide advice on the issues in question; and 5. Experts opinions will be posted on the Network of Experts Traction page. 4
5 The goal of the Network of Experts program is to allow CDRH staff to tap into a virtual network of scientific experts within two weeks of defining a scientific question that CDRH staff have determined needs to be resolved quickly. Experts opinions will ultimately be posted on the Network of Experts Traction page, which is an internal FDA tool providing a centralized location for CDRH to review these materials. Given that this process will be used for scientific questions which need to be quickly addressed, MITA believes that FDA should specify an overall time goal for the entire process. Specifying overall time goals for the entire process is the best way to monitor and measure the timeliness and efficiency of the Network of Experts program, and will be invaluable in assessing whether the program is performing as intended. FDA should institute greater efficiencies on the management and processing of Conflict of Interest (COI) forms and Conflict Disclosure Agreement (CDA) forms It is of critical importance that FDA ensure that the privacy of the manufacturer is protected. MITA recommends that the experts utilized by FDA be blinded to the identity of the manufacturer, in order to eliminate or reduce bias, and to protect the manufacturers privacy rights. The SOP provides that volunteering experts for the program will be asked to submit their names, CVs or resumes, and completed COI and CDA forms (if required) to the sponsoring organization within 7 days for submission to CDRH. MITA recommends that FDA add wording to clarify that the 7 day time period begins when the Network of Experts coordinator sends an to professional organizations, instead of the date when a professional organization notifies its membership. This will enhance the efficiency of the process for acquiring conflict of interest information. The SOP states that self-certifying COI forms will be randomly audited by CDRH ethics staff to make sure the Agency is receiving reliable information on actual and potential conflicts of interest, and to ensure they are appropriately managed. MITA recommends that FDA perform an audit of all COIs, rather than a random sampling. It is anticipated that since the number of COI forms from experts participating in the Network of Experts Program should be less than those submitted by Special Government Employees (SGEs), MITA believes this is an achievable goal. This will provide to the Agency more complete disclosure of potential conflicts of interests of participating experts in the program. In addition, the SOP provides that the CDA and COI forms will be considered valid for six months unless a reviewer indicates they are needed for a longer period. It further states that the CDA and COI forms will not remain valid for longer than nine months, and, if experts are required for a longer period, they will need to complete a new screening application. In order to keep FDA current regarding potential conflicts of interest among its participating experts, it is recommended that external experts proactively notify FDA and their respective professional organizations within a specified number of days if the circumstances regarding their COI and CDA should change. 5
6 Conclusion MITA supports FDA in its outreach efforts to those professionals and organizations which possess expert knowledge on medical and scientific issues, with are relevant to the Agency s mission, as stated in its Network of Experts program. We believe that while this program may provide benefits to FDA and the review process, it is important to ensure that the program is implemented appropriately, and that transparency of the program is maintained. We believe that, in order to enable FDA to gain a full and balanced understanding on important medical and scientific issues, industry should be permitted to contribute its own unique and valuable experience and expertise on these issues, and act as partners in the FDA Network of Experts program. It is critically important that FDA carefully consider what impacts the Network of Experts program will have on the 510(k) process, and the Agency should ensure that the timeliness and efficiency of the 510(k) process will not be adversely affected. To best manage the Network of Experts program, FDA should set time goals for the entire process, so that the program fulfills its mission to provide FDA with scientific expertise in an expeditious and efficient manner, for issues which need to be resolved quickly. The Agency should strengthen the expert enrollment process by clarifying how outside organizations can proactively make FDA aware of their existence and areas of expertise, along with instituting greater efficiencies in the management and processing of conflicts of interest issues. If you have further questions, please contact me directly at (703) , or by at dfisher@medicalimaging.org. Sincerely, David Fisher Executive Director Medical Imaging & Technology Alliance 6
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