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CDRH FY 2019 Proposed Guidance Development and Retrospective Review

By: Jeff Shuren, M.D., J.D., Director, Center for Devices and Radiological Health

Photo of Jeffrey E. Shuren, M.D, J.D.
CDRH Director, Jeff Shuren, M.D., J.D.

FDA guidances explain the agency’s interpretation of, or policy on, a regulatory issue. The agency and its centers prepare guidances for industry, but also for other customers, including our own staff, to address areas including design, manufacturing, and testing of regulated products, scientific issues, content and evaluation of applications for product approvals, postmarket surveillance, and inspection and enforcement policies.

For the Center for Devices and Radiological Health (CDRH), our guidance development processes are driven by our goal of helping to get safe and effective medical devices to market in a timely manner, and are informed by feedback from our customers, including patients, the medical community and industry.

In today’s Federal Register, CDRH announced the list of guidance documents we intend to publish this fiscal year (FY2019). In addition, we committed to reviewing previously published final guidance documents, updating, or deleting guidance documents that no longer represent the agency’s current thinking on a regulatory issue.

The Center posted two lists (A/B) of guidance documents that we intend to publish during the upcoming fiscal year. In addition to reflecting our priorities for FY2019, these guidances also satisfy requirements outlined in the 21st Century Cures Act and the FDA Reauthorization Act (FDARA), which includes, among other things, the Medical Device User Fee Amendments (MDUFA IV) , all of which aim to help us accelerate medical device product development and bring new, safe and effective innovations and advances to patients who need them faster and more efficiently.

Prioritizing digital health

As Commissioner Gottlieb noted in his September 26, 2018, FDA Voices piece, Advancing Innovation in Digital Health, digital health devices have the potential to improve our ability to accurately diagnose and treat disease, and to enhance the delivery of health care for the individual. Digital health offers real opportunities to improve health outcomes, enhance efficiency and reduce costs. The promise of these technologies, and the rapid pace of change in this area, have prompted the FDA to explore ways to modernize our regulatory approach to better advance safe, effective innovation in this rapidly evolving area.

Five of the guidances on our FY2019 list focus on supporting continued innovation and safety in digital health. These guidances aim to 1) help developers understand the premarket submissions for medical device software; 2) clarify the need for validation and documentation for automated computer software assurance; 3) provide clarity on the FDA’s oversight of clinical and patient decision support software; 4) provide additional clarity for software developers on whether certain functions meet the definition of a device; and, 5) provide clarity on the FDA’s policy for the review of multiple function device products.

Advancing device safety and security

Cybersecurity threats will continue to evolve, posing greater risk and disruption to patients and healthcare facilities every day, making it critical to update our premarket submission cyber guidance with new recommendations to mitigate these risks based on our growing experience. This commitment was reinforced earlier this week in a statement by the Commissioner. Dr. Gottlieb recognizes CDRH’s holistic, systematic approach to building our medical device cybersecurity program, and creating an environment that fosters a shared responsibility and includes industry and other customers.

A priority identified in the FDA Medical Device Safety Action Plan from April 2018 is to update the current premarket cybersecurity guidance in which we intend to address the continuous cyber risk to medical devices including recommendations regarding device design aspects, risk management, and labeling, to assure device cybersecurity, maintain device functionality, and reduce potential risks to patients.

Additionally, CDRH intends to issue other draft guidances to address device-specific safety issues or promote visibility related to specific labeling or testing recommendations, such as for ventilators and surgical staplers.

Offering more flexibility and options for premarket submissions

Included on the list are two guidances for CDRH’s 510(k) Program. One guidance offers manufacturers additional flexibility in how to demonstrate substantial equivalence between a new device and a predicate device (a device that is already legally marketed). The other guidance describes updates to the Special 510(k) program, an optional pathway for certain well-defined device modifications, and clarifies the types of modifications eligible for review under this program.

Sustaining high-quality servicing

As part of the agency’s implementation of requirements associated with the Food and Drug Administration Reauthorization Act (FDARA), a draft guidance on Medical Device Servicing is intended to be published to provide clarity associated with high quality servicing by industry, helping to distinguish when activities are considered servicing versus remanufacturing.

Efficient oversight

Applying the least burdensome approach to the work we do is also a priority for CDRH that was extended in scope in the 21st Century Cures Act. We define “least burdensome” to be the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient manner at the right time. This concept applies to all products that meet the statutory definition of a device and throughout the total product lifecycle (premarket and postmarket).

We’ve included on the list a final guidance we intend to publish on how we apply least burdensome concepts and principles throughout the total product lifecycle of a device. Based on feedback we received on the draft guidance, we’ve included references and examples to help illustrate the least burdensome approach. We aim to apply the least burdensome approach to device activities throughout the total product lifecycle, not just those actions for which Congress requires it.

Our focus and one of CDRH’s key strategic priorities has been a more holistic view towards evidence generation, by trying to strike the right balance between premarket and postmarket data collection—in other words, asking for the least burdensome evidence of safety and effectiveness necessary to approve or clear a device to enter the market versus what data could be appropriately gathered following market authorization. By striking the right balance between premarket and postmarket data collection we can help assure we get the right data at the right time, thereby creating incentives for timely patient access to high-quality, safe and effective technologies to improve their health and quality of life.

Handling uncertainty in devices

There is always some uncertainty about a device prior to market authorization and use by patients in real-world settings. The final guidance for considering uncertainty in making benefit-risk determinations in certain medical device premarket decisions is another key guidance on the list. It would advance a consistent, methodical and science-based approach we would apply when we take uncertainty into account during a benefit-risk determination to support certain medical device premarket decisions. Factors to be considered, as appropriate, in uncertainty include, but are not limited to, the public health need for the device, including the availability of alternative treatment, and the ability to reduce or resolve uncertainty through robust data collection in the postmarket phase. We may be willing to accept greater uncertainty, for instance, for a product that meets an unmet medical need, when no alternative treatments are available, provided that the applicable premarket standards are met, and will continue to evaluate the safety and effectiveness of the device once it’s authorized.

Engaging patients

Including feedback and perspectives of patients in the development of medical devices is inherent in CDRH’s processes. It’s part of our public health mission to help patients better understand their healthcare options. Across the Center we are testing and developing meaningful ways to engage patients. This draft guidance would clarify the types of patient input activities intended to make clinical trials more patient-friendly, while enhancing patient recruitment and engagement in clinical trials. This includes activities such as seeking patient input on study inclusion criteria and follow-up schedules, and including patient perspectives in defining meaningful study endpoints, including patient-reported outcomes.

This draft guidance is being written in response to recommendations CDRH received through our Patient Engagement Advisory Committee (PEAC) in 2017, and supports our MDUFA IV commitments to advance ways of using patient input to inform clinical study design and conduct, with the goal of reducing unnecessary barriers to patient participation, facilitating recruitment and retention, and improving the quality of clinical study data. We are currently planning for the next PEAC meeting, which will be held on November 15th of this year.

Each of the guidance documents mentioned above were or will be developed with the intent of strengthening our work and collaboration with our customers including patients, healthcare professionals, and industry, and are intended to benefit patient health.

CDRH employees also benefit from these guidances because they provide them with more clarity, consistency, and the ability to apply a more holistic total product lifecycle approach to our oversight of devices. Ultimately, these FY2019 guidances consider the impact on, and are intended to benefit, our most important customer – patients. Your feedback on these guidances is essential to ensuring that medical devices are safe and effective.

Comments are submitted electronically at the Federal eRulemaking Portal and will be posted to the docket unchanged.


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