Building on the FDA’s goals and strategies for creating a national evaluation system for medical devices, the FDA has recently increased its focus on collaboration with the medical device community, as well as patient involvement, to promote public health with high-quality and safe medical devices.
The FDA recently released “2016–2017 Strategic Priorities”1 for the Center for Devices and Radiological Health (CDRH), which explains how the CDRH intends to accomplish these goals. The CDRH has implemented new programs and strategies that focus on patients’ input, stakeholder engagement and data transparency. According to “Strategic Priorities,” the CDRH’s current vision is to “assure the U.S. is the world’s leader in medical device regulatory science, innovation, and manufacturing; establish a robust post market surveillance system; assure that devices on the market remain safe, effective, and high quality; and assure consumers, patients, caregivers, and providers have access to the information they need to make well-informed decisions.”
Patient Participation
One CDRH focus is on partnering with patients to provide patient perspective regarding patient preference information, risk-benefit analysis and device labeling. The CDRH has used patient representatives for advisory opinions, but it recently increased patient-reported outcome measures in clinical studies to meet patients’ needs. Last year, the CDRH established the Patient Engagement Advisory Committee to communicate regarding important topics that require patient input, and CDRH intends to identify and define the regulatory uses of patient report outcome measures, both premarket and postmarket, to identify patterns and gaps. This committee consists of outside experts who will conduct public meetings twice yearly and is intended to provide additional perspective on patient preference, risk-benefit analysis and labeling of devices. Patients will be able to submit adverse event reports and other methods of outcome reporting to provide additional input on device regulation, with an expectation that this will avoid problems posed by inadequate patient communication, which has sometimes led to medical complications. Because patient groups are often sponsored by the medical device industry, patient advocates have concerns and question whether segregating patients’ representatives into their own panel is helpful.
The CDRH believes the key to success is the use of real-world data to support the efficient identification of safety issues with medical devices. More patient involvement through informed decision-making will be important, as will increasing how information is presented to make it more patient-friendly. The patient perspective will be used to analyze risks and benefits, which the CDRH expects will better meet the needs of patients and promote the safety of medical devices. One example of this effort is the development of the Patient-Centered Benefit-Risk Framework and the assessment methods catalog developed through participation in the Medical Device Innovation Consortium (MDIC). The MDIC, a public-private partnership with the FDA and other stakeholders, aims to advance regulatory science in the industry by developing tools and methods to manage the total product life cycle of a medical device through the use of maturity models. There is currently no recognized quality system maturity model, and the goal of the MDIC is to understand various models to create a plan for developing a model for industry partners and regulators in the medical device community to use.
Industry Collaboration
The CDRH has also prioritized establishment of a planning board to collaborate more regularly and efficiently with the medical device community. The CDRH first set out a strategy and steps for creating this type of national system in 2012 and 2013, and multistakeholder groups in 2015 endorsed the vision, upon which the CDRH now intends to build its main goals in this area. The CDRH intends to increase both access to and use of real-world evidence to support regulatory decision-making. The CDRH’s goal is access to 25 million electronic patient records with device identification by the end of 2016 and access to 100 million such records a year later.
The FDA’s National Medical Device Evaluation System Planning Board proposed a public-private partnership “coordinating center” to create a national system to evaluate medical devices, made up of members of the pharmaceutical industry, government, industry groups and researchers. The goal is for the coordinating center to encourage quality healthcare and reduce costs. The FDA intends to accomplish that goal by allowing manufacturers to receive approval for their devices more quickly, utilizing data use agreements that allow members to share data, such as electronic records and clinical trial data. The National Evaluation System uses real-world data to efficiently identity and manage device safety issues. This system would encourage innovators to study their technologies and bring their products to patients in the United States first. This priority demonstrates the focus on patients and stakeholders, particularly as it relates to reporting, to advance patient safety and meet patient needs.
Case for Quality
The third main focus of the CDRH is to achieve quality and organizational excellence through implementation and expansion of the Quality Management Framework. The CDRH worked with the FDA Office of Regulatory Affairs in 2011 to create the Case for Quality initiative, which is defined in “Strategic Priorities” as:
an initiative undertaken in collaboration with other members of the device ecosystem, to identify those practices that can promote a culture of quality and the implementation of a quality management approach that fosters continuous product quality. CDRH envisions a future state where the medical device ecosystem is inherently focused on device features and manufacturing practices that have the greatest impact on product quality and patient safety. Internally, this requires a shift in our traditional regulatory approach, toward a model that is preventive of problems before they occur, that adapts to changes in science and technology, and that rapidly addresses events that impact safety. Externally, this requires partnerships and shared responsibility among FDA, industry, practitioners, and patients to continually evaluate and adjust based on experiences across the full life cycle of a device.
The core components of the Case for Quality include a focus on quality, enhanced transparency of data and increased stakeholder engagement. Specifically, “Strategic Priorities” explains, “The [Case for Quality] initiative treats compliance as a baseline, giving greater emphasis to the FDA and stakeholders focusing on critical-to-quality practices that correlate to higher quality outcomes. The FDA is working with stakeholders to promote manufacturers’ implementation of critical-to-quality practices in day-to-day device design and production. The FDA is also looking for ways to recognize these practices in its own operations.”
Further, the FDA plans to enhance data transparency by leveraging the broad array of data it receives from recall and adverse event reports, in addition to inspection results, to support device quality in numerous ways. For example, the CDRH has stated in “Strategic Priorities” that “to enhance independent analyses by stakeholders, the FDA is exploring publishing our data so that it can be automatically accessed and searched by external analytical tools. We’re also conducting analyses of our data and publishing these analyses. These reports will draw from our recall data as well as inspectional observations and warning letters.” Lastly, the FDA has been meeting with stakeholders to obtain feedback on the Case for Quality, which encourages a collaborative approach to compliance and quality control in the area of medical devices, and promotes new initiatives that differ from more traditional oversight models.
Additionally, the Voluntary Compliance Improvement Program and the Medical Device Single Audit Program (MDSAP) will complement the Case for Quality by identifying issues of quality and factors that will create new ways for patients to have access to the best medical devices possible, even when financial barriers exist. The program will coordinate manufacturing facility inspections across five countries by using certified inspectors from private firms. To date, the industry has not embraced this program. Only 45 manufacturing sites have expressed interest in participating, far short of the goal of 330 sites becoming involved by the end of 2016. The FDA has signaled that participation is voluntary, but it could become mandatory to reduce the number of inspections by having a single regulatory audit. The CDRH plans to have systems and procedures in place by September 30, 2017, to be eligible for ISO 9001 certification, and it intends to use resources to continue building upon the CDRH Quality Management Framework.
The CDRH has outlined goals for promoting this type of collaborative culture, including strengthening both the FDA’s culture of quality within the CDRH and product and manufacturing quality within the larger medical device ecosystem. The FDA and the CDRH believe that the Case for Quality does more than simply allow for improved oversight of manufacturers and increased collaboration and sharing of ideas. It also allows the FDA to collaborate with stakeholders to identify and share important quality practices. The FDA expects that manufacturers’ bottom lines will benefit from the Case for Quality, and it has cited a study that found that these types of practices can reduce quality-related costs by up to 20 to 30 percent and can increase profits by 3 to 4 percent. In sum, the goal is that the Case for Quality will create higher-quality devices that encourage the goals of the FDA by protecting and promoting the public health. This would enable the FDA to identify quality-capable firms to which less compliance attention and resources must be directed, which will in turn promote production of high-quality devices.
What Can the Industry Expect?
Increased inclusion of patients and stakeholders in the discussion of medical devices and their safety is the key to success, according to CDRH, and partnering with the medical device community to create a public-private partnership is expected to foster a better and safer system. As stated in “Strategic Priorities,” the CDRH is prioritizing its collaboration with members of the medical device community pursuant to the Case for Quality “to identify, develop and pilot metrics, successful practices, standards, and evaluation tools that will be specific to the medical device industry and focus on assuring product and manufacturing quality.”
The CDRH’s recent efforts to engage with patients and stakeholders will become even more important per the new “Strategic Priorities,” and as counsel to medical device manufacturers, we will monitor how these goals and strategies fare. Many stakeholders have sought the use of more FDA resources and effort on postmarket vigilance, and for more efficient approvals as a result, which could result in shorter approval times for certain devices. Some consumer advocates and health researchers have been critical, opining that the FDA should use scientific research – not patient preference – to decide whether to approve medical devices. Some agree that patients should have a voice, but they remain unconvinced that having them on their own panel will offer real benefit. They also remain skeptical about whether the patient representatives of the patient-centric advisory committees are independent and without experience in devices.
Notwithstanding the paucity of manufacturers participating in the audit program, manufacturers should expect audits will model the scope declared in their applications for certification of services, as well as on the regulatory requirements of countries where the manufacturer sells or registers its devices. To prepare, manufacturers should perform internal audits using applicable MDSAP documents.
1 All references to the 2016–2017 Strategic Priorities can be found on the FDA’s website at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTob....
Published May 5, 2016.
