Medical device experts discussed at the 2024 RAPS Global Regulatory Strategy Conference how to submit materials for the FDA’s Breakthrough Devices program and the Safety Technology Plan (STeP), as well as how to respond to deficiency letters.
Regulatory consultants Melissa Hall and Caroline Rhim provided case studies to explain effective submission and communication strategies. Both speakers are former FDA reviewers.
Breakthrough Devices and STeP Program
Rhim stated that despite slight fluctuations in recent years, the number of breakthrough designations has been steadily increasing. In 2023, 167 breakthrough devices were approved, slightly higher than the 166 in 2022, a significant increase compared to previous years of the program and its predecessor, the Expedited Access Pathway (EAP). Additionally, the STeP program has approved a total of 35 devices, with 15 approved in 2023.
The STeP program, announced in 2020, aims to expedite approval for devices and device-led combination products but does not cover diseases as severe as those covered by the Breakthrough program.
Avoiding Derailment
Rhim also provided a case study to demonstrate why a novel software device was rejected as a breakthrough device application. The applicant chose the wrong type of meeting with the FDA. The applicant requested a sprint discussion with the FDA instead of asking for a more intensive meeting, which would have raised more questions.
Applicants can choose to interact with the FDA by conducting sprint discussions (to discuss data development plans) or by reaching agreement on clinical protocols. The final FDA guidance on the Breakthrough Devices Program states that sprint discussions are intended to “support applicants needing to address potential new issues in a timely manner.” The FDA provides sprint discussions with the goal of reaching consensus on specific topics within a specified time frame (e.g., 45 days).
Rim explained that the purpose of sprint discussions is to focus applicants on specific areas with the FDA. However, in this case, the applicant utilized these meetings to raise broad questions that were not particularly focused. Generally, the FDA would provide them with a wealth of feedback, which would snowball with each meeting.
She added that the questions the applicants posed to the FDA were “ones they should have been answering themselves.” The applicant had more than a dozen such sprint discussions with the FDA. “As more feedback needing resolution emerged with each meeting, this submission path started to unravel.”
In another example, a new Class III implant device was granted breakthrough device designation. Rim explained that the applicant had a “focused, on-point” sprint discussion regarding the clinical protocol.
Rim also offered other tips to avoid derailment, such as using templates in submissions. She said, “Templates are great; what makes me happier than an easy-to-understand template?”
Furthermore, she suggested applicants use a “tracker” in their submissions, which can capture the regulatory history of the device and how the applicant addressed agency feedback. Additionally, applicants should use traceability tools to show how submission content has been updated from previous versions to the present.
Responding to Deficiency Letters
Another point emphasized by Rim is that sponsors should provide a holistic response to deficiency letters rather than having different departments of the company focus only on deficiencies relevant to them.
Clinical and statistical personnel did not request that every discipline within the company address deficiencies in their areas, such as biocompatibility, but rather “read their own sections and skip the rest.” She said, “All deficiency letters have common threads. We recommend that each team reads the entire deficiency letter, and you’ll see some common themes emerge.”
Remote Work and Review Cross-Collaboration
On the other hand, Hall discussed some recent FDA hiring patterns, noting that in recent years, the FDA has allowed more employees to work remotely. The agency is also recruiting more employees outside the Washington, D.C. metropolitan area.
Regarding reviews, Hall pointed out that the FDA allows staff to review applications that may extend beyond their areas of expertise. This cross-collaboration was created under the 2020 Product Lifecycle Reengineering (TPLC) restructuring, which allows staff to work outside their disciplines to broaden their knowledge base. “The program allows staff to collaborate across different areas, you may see some people typically working in the Office of Science and Engineering Laboratories (OSEL) wanting to become lead reviewers, or a lead reviewer wanting to venture into policy and understand how De Novo operates.”
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