Earlier this month, the Food and Drug Administration (FDA) announced its plan to establish a centralized digital health unit within the Center for Devices and Radiological Health (CDRH). We caught up with one of our principal consultants, Sugato De, to discuss this development. Sugato has extensive expertise in the digital health space and over nine years of FDA experience, first as an engineer and then as a senior policy advisor in the Office of the Center Director (OCD).
Q1: What drove the FDA’s decision to establish this unit?
A1: The unit’s underlying goal is to provide the Office of the Center Director (OCD) with technical expertise to facilitate review of premarket submissions that incorporate digital health technologies, including software that functions independently as a medical device (SaMD), software embedded in medical devices (SiMD), and/or interoperable devices. The unit will also be heavily involved in developing and implementing policies and regulatory guidance documents relating to digital health.
Q2: How did market forces and legislation influence the FDA’s decision?
A2: The proliferation of digital health technologies has led to a fundamental paradigm shift in the regulatory approach to medical device software. The FDA committed to establishing a regulatory framework for software that functions independently as a medical device and also for software embedded in medical devices as part of the Medical Device User Fee Amendments of 2017 (MDUFA IV). In particular, the MDUFA IV agreement directs the FDA to explore opportunities for establishing premarket approval and clearance pathways tailored to digital health technologies. CDRH established this unit to ensure proper coordination and consistency in implementing those pathways.
Q3: What are some of the FDA’s ongoing efforts in digital health?
A3: CDRH has taken major steps to clarify regulatory policy associated with digital health technologies. Specifically, in the last two years, CDRH has published final guidance documents that cover mobile medical applications, medical device data systems, interoperable medical devices, cybersecurity, and general wellness products. In addition, CDRH has issued draft guidance documents that cover software that functions as a medical device and what types of modifications to software require regulatory submission.
In the coming years, the new digital health unit will likely prioritize the finalization of the aforementioned draft documents and will also spearhead a comprehensive update existing final guidance that covers recommended content for premarket submissions relating to software contained in medical devices. This unit may also help to address the long-controversial topic of the regulation of clinical decision support software.
Q4: How will the digital health unit advance those efforts?
A4: CDRH has traditionally struggled to consistently interpret existing policy in this area. In particular, there is often a disconnect between how the Office of Device Evaluation and the Office of In Vitro Diagnostic and Radiological Health interpret existing software-related regulatory requirements for premarket submissions.
Establishing a digital health unit in OCD, which is responsible for harmonizing policies in the CDRH, should help to address this inconsistency. Further, the unit’s specialized expertise in software development and validation should be a valuable resource to divisions reviewing premarket submissions containing these technologies.
Q5: What challenges will this unit need to overcome to fulfill its mandate?
A5: The unit’s work requires staff members with specialized expertise in emerging digital health technology fields, such as cloud computing, artificial intelligence, and cybersecurity. It may be a challenge for the FDA to recruit and retain these experts, given the high demand in the medical device industry and beyond.
The MDUFA IV agreement compounds the difficulty a bit by prohibiting the FDA from reassigning existing staff with expertise in these areas to the digital health unit. Bringing in new talent may add fresh perspectives on existing digital health policy. However, their potential lack of familiarity with existing regulatory processes may lead to challenges in developing policies that address the diverse range of software-related devices under CDRH’s jurisdiction.
Accordingly, it will be important for this unit to draw on the experience of current CDRH staff members to ensure that new policies adequately address outstanding gaps in regulatory policy. Further, it bears noting that digital health technology is increasingly prominent in combination products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The digital health unit must engage with experts in CDER and CBER to ensure consistent policy interpretation and implementation.
Q6: How can PAREXEL’s clients benefit from this development?
A6: PAREXEL has experts with direct first-hand experience with working within FDA’s framework in developing and executing regulatory programs for digital health technologies, including mobile medical applications, clinical decision support software, general wellness products, and SaMD.
Given this background and extensive corresponding expertise in the regulation of medical devices, biologics, and drugs, PAREXEL is uniquely positioned to provide strategic support to its clients bringing digital health technologies to market.
Regulatory and Market Access
Regulatory Compliance & Remediation
Digital Health Unit