Re: Docket No. FDA-2000-D-0067: Medical Device Patient Labeling; Request for Comments; Public Workshop

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1 701 Pennsylvania Avenue, NW Suite 800 Washington, D.C Tel: Fax: October 30, 2015 Division of Dockets Management (HFA305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD Re: Docket No. FDA-2000-D-0067: ; Request for Comments; Public Workshop To Whom It May Concern: The Advanced Medical Technology Association ( AdvaMed ) appreciates the opportunity to provide comments in response to the Food and Drug Administration s ( FDA or Agency ) Notice in the above mentioned docket. AdvaMed represents manufacturers of medical devices, diagnostic products, and health information systems that are transforming health care through earlier disease detection, less invasive procedures, and more effective treatment. Our members range from the smallest to the largest medical technology innovators and companies. In the subject Federal Register Notice, FDA invites comments regarding a number of questions related to medical device patient labeling. Our specific comments to these questions can be found in the attached document. In general, we appreciate FDA s prior development of the Guidance on. 1 The Guidance has been used for over a decade by the industry with positive results, helping to ensure patient labeling is clear, well written, and provides relevant information. However, the ultimate challenge with patient labeling is to provide needed information without overwhelming the user with unnecessary information. This is especially true for an industry such as medical devices, which includes products that vary in size, complexity, and frequency of use. The use of some medical devices may require fine motor skills, others require a series of complex steps to set-up and operate, including periodic replacement of accessories or supplies that come from various sources. Devices may be used for days, weeks, or years, or used once and discarded. Devices may be modified over time to provide enhanced features and capabilities. Devices are used in a wide variety of settings including hospitals, schools, senior care centers, home care settings, and military applications. Finally, 1 Guidance on ; Final Guidance for Industry and FDA Reviewers (April 19, 2001), available at 01.pdf. Bringing innovation to patient care worldwide

2 Docket No. FDA-2000-D-0067 October 30, 2015 Page 2 of 4 devices are used by healthcare professionals, patients, and caregivers, each with their own segmentation and own unique comprehension level. This variety demands an extremely focused approach to developing and validating user instructions and other labeling for each device type, and in some cases, user groups and market placement. Manufacturers expend great effort and resources to ensure their devices are designed and manufactured properly, such that they can be used safely and effectively. This effort includes the creation and distribution of accurate, complete, and appropriate labeling for each device type. Accordingly, any changes to the patient labeling guidance, or new requirements, must be carefully considered. Repository During FDA s September 29-30, 2015 public workshop on medical device patient labeling ( Public Workshop ), 2 several public speakers expressed that a medical device labeling repository would be beneficial, including use of the UDI database for this purpose. As AdvaMed has stated in previous comments to the Agency, 3 an online medical device repository would pose numerous problems, including risk to patient safety due to the number of medical devices and the frequency of which patient labeling may be updated. Medical device patient labeling may be updated or changed after a product is out of the manufacturer s control. As a result, many manufacturers maintain device labeling online as an efficient means of maintaining version control, storage, and distribution of device information. In addition, the internet is just one possible means of information delivery. As a result, it is essential to understand the nature of the information to be delivered and the manner in which the information will be used for it to be delivered in the most effective manner. For example, the user or caregiver may need assistance in initial set-up, a reminder how to manage a routine situation, or critical help in solving an immediate problem which they never experienced or anticipated. Manufacturers invest in the human capital to provide assistance to device users and caregivers. This includes strong training and educational programs as well as customer/technical support where manufacturer representatives are educated in the purpose, use, and limitations of devices. Such programs help manufacturer representatives in understanding the difficulties encountered by users and, through interactive dialogue, help guide users to a solution. An online repository for all medical devices may divert users from human interaction with Customer Service personnel trained in the operation and maintenance 2 Public Workshop (Sep , 2015), available at 3 See Comments from AdvaMed (May 17, 2013), in response to FDA Docket No N-1205 (Accessible in a Standard Content and Format).

3 Docket No. FDA-2000-D-0067 October 30, 2015 Page 3 of 4 of their devices, which is more readily available when such information is accessed through the pathways defined by the manufacturer (e.g., website or telephone number). Manufacturers have also invested in creating and managing different types of user labeling. While, some devices are more suited to electronic labeling, whether in digital media such as CDs, cloud services, or embedded in the device itself, other devices and user environments are more suited to traditional printed labeling, some with abbreviated user instructions, such as Quick Reference Guides. Preference Data Also during the Public Workshop, the Agency provided an overview of its Preference initiative, which allows sponsors to voluntarily submit data reflecting patient perspectives on risk/benefit decisions for preference-sensitive types of devices. FDA stated at the Public Workshop and in the draft guidance on this topic that the results of patient preference studies should be presented in patient labeling. AdvaMed does not agree. Not all patient preference information that is used to support regulatory decision making should be described in the labeling. Very few preference studies have been conducted to date, so it is not clear what impact, if any, the inclusion of this information in the labeling would have. More research is required on effective communication of this information to patients, and studies should be conducted to determine whether patients would be interested in such information. Further, providing all types of patient preference information in product labeling may introduce an additional threshold of data in product labeling that is not currently standard practice. For example, today, information used to support clinical trial design typically is not included in product labeling. However, patient preference data used to substantiate minimum clinically meaningful benefit would be more comparable to data that are currently provided in the clinical section of the device labeling. 4 Off-Label Information FDA should not recommend in its patient labeling guidance methods by which a medical device manufacturer should or could promote off-label uses of its medical device. Due to the evolving jurisprudence on off-label communication, we believe FDA should address this issue in a separate guidance. 4 See also Comments from AdvaMed (Aug. 17, 2015), in response to FDA Docket No D-1580 ( Preference Information Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Device ; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability).

4 Docket No. FDA-2000-D-0067 October 30, 2015 Page 4 of 4 Product Information Available to s Published by Federal Agencies We also recommend that Federal agencies publish product information intended for patients using the same principles described by FDA for medical device patient labeling. While AdvaMed applauds and shares FDA s value of transparency, failure to provide clear, concise and understandable information will lead to confusion and, perhaps, inconsistency with the information provided by the manufacturer. For example, the National Institutes of Health, National Library of Medicine, maintains the accessgudid database. The database, while useful in many contexts, may also lead to patient confusion. For example, in response to the question, What MRI safety information does the labeling contain, a manufacturer must choose from one of the following: MR Safe; MR Unsafe; MR Conditional; or, does not contain MRI Safety information. The public database fails to define what these answers mean, so the lay user, or patient, may very well be confused with these responses. Another example is the data elements related to latex labeling. The GUDID data point on this topic asks whether the device is required to be labeled as containing natural rubber latex or dry natural rubber. The second data element asks whether the device is labeled as not made with natural rubber latex. While the data mirrors the yes or no answers provided by the manufacturer, it does not translate well to a lay user. Therefore, a patient with a latex allergy would have difficulty understanding the meaning of the manufacturer s answer. To ensure patients receive clear, concise, consistent, and understandable information, the communication principles described in the current and future guidance should apply through the product s entire lifecycle, including product label information shared by a Federal agency. * * * AdvaMed would like to thank the Agency for its thoughtful consideration of these comments. If you have any questions, please do not hesitate to contact me at or zrothstein@advamed.org. Respectfully submitted, /s/ Zachary A. Rothstein Associate Vice President Technology and Regulatory Affairs Attachment

5 AdvaMed Comments Document Title: ; Request for Comments; Public Workshop # Section Question Comments 1 A. Current (1) When is medical device patient labeling used? As discussed during the Public Workshop, medical device patient labeling is diverse and varied. Some medical devices do not include patient labeling, while other devices include comprehensive manuals. Because of the diversity of medical devices, a guidance document for patient labeling must consider all the different types of patient labeling that exist. 2 A. Current How much medical device patient labeling exists? Generally, medical device patient labeling is used by the intended user of the medical device, specifically a patient or patient s caregiver. This labeling may be reviewed by the patient or caregiver with the healthcare practitioner prior to use of the device (assuming a prescription device), or even before the device is purchased to better understand what is required for its effective use, as well as possible risks or side-effects associated with the device. It may also be used to maintain long-term or chronically implantable medical devices, and therefore, it is important that the labeling is available on-hand and easily accessible to the patients or their caregivers. FDA s guidance 1 on patient labeling states that there are two general categories of information: (1) Risk/benefit information; and (2) instructions for use. Risk/benefit information is utilized when a patient must decide whether to use a device. This information also allows the user to become aware of potential problems or side-effects associated with use of the device. Instructions for Use are the procedural steps to follow in setting up, using, cleaning, troubleshooting, and storing a device. 3 A. Current How much modification and revision of existing medical device patient labeling occurs, and under what circumstances? While it is important to ensure that patient labeling provides both risk/benefit and instructions for use information, it is also important to ensure that the labeling is useful in practice and not overwhelming for the patient. labeling should provide information that is necessary for the patient to use the medical device in a safe and effective manner, in a way that is understandable, and does not overburden the patient. Additionally, a balance must be struck between the risk and benefit information. The labeling should enable a patient to make an informed decision without dissuading them from use of a safe and effective device. Modification and revision to existing medical device patient labeling may occur. These can range from simple typographical changes to major changes, such as updated designs or changes to risk information. These labeling modifications/revisions can prove challenging from an implementation perspective due to costs, time and logistical considerations. Manufacturers react promptly to safety related labeling updates (e.g., updates associated with Changes Being Effected 1 1

6 # Section Question Comments 4 A. Current 5 A. Current 6 A. Current What is the role of voluntary consensus standards in developing medical device patient labeling? (2) What risks or adverse outcomes have been reported in association with the use of medical device patient labeling? What communication barriers have been encountered, and how can they be mitigated? (3) Is there any part of the medical device patient labeling development process that presents a barrier to receiving approval or clearance from CDRH? If so, please provide examples of the specific issues, how frequently this occurs, and suggestions which constructively address these barriers. submissions) by implementing the update with urgency. It is possible that electronic methods of delivering patient labeling may be beneficial to both the manufacturer and patient. For example, manufacturers can promptly provide the most up-to-date version of the patient labeling electronically either through their own website or other controlled electronic mediums (e.g., mobile application). In addition to following FDA s Quality System Regulations (QSR), device manufacturers also follow various standards during labeling design and development. For example, manufacturers may utilize a labeling checklist that includes voluntary consensus standards and other appropriate industry standards. AdvaMed agrees with the current patient labeling guidance, which states that the use of consensus standards can increase predictability, streamline premarket review, provide clearer regulatory expectations, and facilitate market entry for safe and effective medical products. In addition, consensus standards can provide consistency for users across a device type or space so information is presented in a uniform manner among manufacturers, such as with the use of symbols. An important communication barrier occurs if patients or their caregivers do not receive patient labeling in a timely manner. Aspects to consider include the environment in which the patient receives the patient labeling and the condition of the patient when he or she receives it. Such considerations are important for devices that are surgically implanted or require immediate post-implant instruction. During the implant of sterile devices in the operating room, health care professionals may take the sterile device out of the package and discard the package and the labeling before sharing it with the patient. Complexity, presentation and form-factor of the patient labeling are other communication barriers that may impact the use of patient labeling. Complexity of the labeling may drive the need for a physician or healthcare professional to explain the labeling to the patient. Below are several suggestions to mitigate these communication barriers: - Encourage innovation in design of content both visually (i.e., look and feel) and dynamically (e.g., inclusion of demonstrative videos and animations). - Provide sufficient information for the safe and effective use of the device without providing so much information that the patient becomes overwhelmed. Although patient labeling is generally included at the product submission stage, as discussed during the Public Workshop, FDA feedback typically is not received until the end of the review period. This is, of course, not an ideal time for the Agency to request significant labeling changes. Further, such changes cannot always be made quickly by the labeler, particularly for more innovative forms of labeling such as videos or animation. A mechanism for FDA to provide earlier feedback would be helpful, such as providing guidance during the 100-day meeting for PMA reviews. Any updates to the medical device patient labeling guidance document should include information on how sponsors can receive early feedback on patient labeling design and content issues. 2

7 # Section Question Comments 7 A. Current (4) What are the best ways to foster efficient networking with patients and advocacy groups, academic and professional organizations, industry, standards organizations, and government agencies to address medical device patient labeling needs? We applaud CDRH s efforts in this area, which include the following: - CDRH has established the Engagement Advisory Committee, which will focus on patient engagement and provide advice on complex issues to the FDA Commissioner regarding medical devices, the regulation of devices, and their use by patients. - CDRH also hosted a Preference Initiative Workshop to discuss ways to incorporate patient preferences on the benefit-risk trade-offs of medical devices into the full spectrum of the CDRH s regulatory decision making. - CDRH participates as a member of the Innovation Consortium (MDIC), a non-profit publicprivate partnership. In 2015, MDIC developed a framework for incorporating patient preferences into the device development and assessment process that can be used to develop, design, and market devices that meet the needs of patients. - CDRH also hosts workshops, such as the Public Workshop, to foster engagement and efficient networking with patients, advocacy groups, academic and professional organizations, industry standards organization, and government agencies. 8 B. Needs Assessment (1) Describe the parameters that should be used in determining priority areas of development of medical device patient labeling, including both therapeutic and diagnostic devices It is important to effectively disseminate the learnings from CDRH s initiatives and efforts and to balance the needs and perspectives from participating parties. To ensure there is value in attendance at the workshops, at least one or two prominent and influential guest speakers or thought leaders should be present to share their knowledge and insight. It would also be helpful if the workshop format included hand-on exercises to foster engagement. Effective communication, accurate content, accessibility, and maintenance are four critical parameters that may inform priority areas for development of patient labeling. Ensuring the intended user of the labeling can readily comprehend the content is the most important aspect of labeling. The content of the labeling must be accurate and avoid messaging that could be construed as misleading. The content of the labeling pertains to important information the user must know, such as how to use the device, identified risks, device operating principles, technical support contact information, disposal instructions, and any other information relevant to use of the device. Accessibility of the labeling, either actively by distribution/delivery channels or passively by accessible repositories, should be carefully considered. 9 B. Needs (2) What are best practices for conducting a needs assessment of medical Device manufacturers have a responsibility to make sure patients have access to appropriate labeling upon use of the device. Since there are many commercial devices intended to be used by mobile/ambulatory users it stands to reason that they will not have the labeling originally provided to them at all times. Therefore, it is important to have other means whereby the patient can easily obtain the appropriate labeling. Such options may include a webpage, mobile app, device-labeling integration, or request by phone or for a hardcopy. Customer feedback studies, surveys, and user panels help collect input. Usability testing helps to confirm the testing. 3

8 # Section Question Comments Assessment 10 C. Advancing Development device patient labeling? (1) What could advance the development and use of medical device patient labeling? Expand the scope of the General Program Memorandum #G03-1 regarding electronic labeling for prescription devices 2 to allow distribution of patient labeling in electronic format (currently a paper version is required in device packages). This would enable manufacturers to innovate medical device patient labeling that could be easier to use and understand by designing the content to be both visually and dynamically (e.g., inclusion of demonstrative videos and animation) enhanced. Such visually dynamic content, when done properly, may improve comprehension by not restricting the patient to a written-language medium. The labeling, if available on a patient s programming instrument for example, could then be accessed and referenced at the exact time they have a question, thereby providing greater convenience. Additionally, the content would be searchable, enabling the patient to find the desired content quicker. FDA should also allow increased use of pictures and symbols in medical device patient labeling. 11 C. Advancing Development (2) How should patient labeling be considered in the development stages of all medical device labeling? The development process of all medical device labeling, including patient labeling, is such that: Manufacturers follow the FDA Quality System Regulations Design Controls (21 C.F.R ) to ensure that devices are designed, manufactured, monitored, and improved, resulting in safe devices that can be used safely and effectively. The foundation of Design Controls is the requirement that device design is based on an intended use and user requirements. User requirements must include user specifications and the user s environment and capabilities. These elements are generated through various means including but not limited to, interviews, observations, modeling of user tasks, literature searches, site visits, and postmarket surveillance. The culmination of the design process is design validation, when manufacturers ensure that their device fulfills the defined user needs and intended uses. Design validation involves the testing of production units under actual or simulated use conditions. Design validation also includes the final update to the device risk analysis ensuring that identified risks have been adequately mitigated. During development, activities using patient labeling should not only focus on the quality of the labeling but also on the logistical scenarios around labeling distribution and maintenance (i.e., distribution of the most up-to-date labeling to patients or caregivers). 12 C. Advancing Development (3) What resources (e.g., registries, industry, or If a medical device is studied during clinical trials, surveys may be used to gain feedback on the quality of the labeling and to determine the optimal method of labeling distribution and maintenance. For medical devices that did not require premarket clinical trials, patient advocacy groups may be a resource to gain feedback on the quality, accessibility and maintenance of the labeling. Resources such as industry, patient advocacy groups, healthcare professionals, academic and professional organizations, standards organizations (to the extent they maintain standards relevant to a specific medical device), and 2 4

9 # Section Question Comments 13 C. Advancing Development patient advocacy groups,) could be tapped to advance the development of medical device patient labeling? (4) What are potential changes to guidances and regulations, or advances in current science that may help develop and enhance medical device patient labeling to address the needs of medical device manufacturers, device suppliers, and device users? global government agencies could advance the development of new medical device patient labeling and improve existing labeling. Sharing best practices across the various groups would allow for an open exchange of information helping to develop better patient labeling. Regarding the use of registries, we do not believe sufficient evidence exists to indicate their utility in developing medical device patient labeling. FDA should provide information that shows how registry data could be used in this context, taking into consideration the validity of the data set contained in a device registry. 1) FDA s guidance 3 states that medical device patient labeling is supplied in many formats, for example, as patient brochures, patient leaflets, user manuals, and videotapes. Given the ubiquitous nature of the internet, it is important for the guidance to also acknowledge and discuss the growing need for providing patient labeling via electronic mediums, such as the manufacturer s website or mobile application. Additionally, while it was recognized at the Public Workshop that the patient labeling guidance is comprehensive and informative, the general impression is that the suggested content, checklist and appendices are lengthy and prescriptive. Adequate allowances to deviate from the guidance would better allow manufacturers to tailor the patient labeling, as one standard format is not conducive to the broad range of medical devices and the patient populations that use them. For example, labeling for a patient-operated device, such as a glucose monitor, would require a different structure and approach than labeling for a device in which the patient s role is passive, such as for an implantable cardio defibrillator. To force labeling for both types of devices into the same mold would be counterproductive and result in patient labeling that has less, rather than more, utility. 2) Expand the scope of the General Program Memorandum #G03-1 regarding electronic labeling for prescription devices 4 to also allow distribution of patient labeling in electronic format (currently a paper version is required in device packages). 3) Prescription mobile medical applications or medical device software do not have physical packaging; rather the application or software operates on a mobile platform and may be downloaded directly onto the mobile platform. Manufactures can provide the labeling in electronic form, such as a PDF document or as part of the software, which can be displayed on the mobile platform. This enables labeling to always be available as it is integrated or embedded with the medical app/software. This approach enables efficient maintenance of the labeling, as the most up-to-date FDA approved or cleared labeling can be pushed out to the users through over-the-air updates and downloaded directly to the medical app/software. Therefore, given the continuing technological advances associated with mobile medical applications, FDA should amend 21 C.F.R (2)(c) to include: on or within the package from which the device is to be dispensed or, in the case of software devices or similar

10 # Section Question Comments devices, labeling included within the device, bears.... 4) The guidance should include an increased emphasis on use of technology, device symbols, speech prompts, and recognized standards. Any updates to the guidance and/or regulations should be flexible so that they can be successfully applied across the diverse range of products that encompass the medical device ecosystem. FDA should also review a representative list of medical device types that utilize patient labeling, to ensure the revisions adequately reflect unique consideration of each product type. AdvaMed would be happy to work with FDA to develop such a list. 5) For medical devices that have both physician and patient labeling, the patient labeling guidance should address how these documents should relate to one another. For example, what elements communicated in physician labeling are not necessary for patient labeling? What is the recommended process for manufacturers to make these decisions? 6