FDA and Medical Device Regulations in 2021: Analysis

Attorney Jim Shehan (Lowenstein Sandler) says FDA managed to largely fulfill its core responsibilities of ensuring compliance and helping bring new products to market in 2020 despite having to cope with the Covid-19 pandemic. Writing in a Med Device Online guest column, Shehan says that based on the 2020 record, it is reasonable to assume that FDA will advance a large number of policies and initiatives. He predicts action in these areas: 

•          FDA leadership – Shehan says the race for commissioner is between acting commissioner Janet Woodcock and former deputy commissioner Joshua Sharfstein. He says observers believe Woodcock would focus more on traditional FDA mandates and issues like product development and approval, while Sharfstein would be more likely to prioritize broader public health issues and make more use of the FDA bully pulpit. He expects a nomination within one month and says congressional confirmation hearings will look at the nominee’s approach and what Congress wants from the agency.
•          Compliance – Shehan says companies need to monitor how FDA will adapt its regulation of medical devices that have been granted emergency use authorizations once the public health emergency ends. “It is worth noting that FDA has a history of not ending public health emergencies quickly,” he adds.
•          Safer Technologies Program – Smaller companies with limited resources should familiarize themselves with the Safer Technologies Program that is intended to give device companies earlier and greater interaction with FDA reviewers, the article says. The program is intended to improve the approval path for devices that can have meaningful impacts for patients but do not meet the stringent criteria to be considered breakthrough devices.
•          Regulatory Science – The four focus areas for 2021 are public health emergency preparedness and response, increasing choice and competition through innovation, unleashing the power of data, and empowering patients and consumers. Shehan calls on medical device companies to particularly monitor the data area.
•          Medical Device Servicing and Remanufacturing – Shehan sees increased activity in this area, beginning with an attempt by the new administration to clarify the difference between servicing and remanufacturing. He says to watch for FDA regulations or guidance and possibly legislation.
•          Additive Manufacturing – An FDA pandemic study summarized the impact of 3D printing (also known as additive manufacturing) on the overall Covid-19 response and in particular its use to rapidly increase the supply of personal protective equipment. Shehan says additive manufacturing is expected to have a growing impact on the medical device field and he expects to hear more from the agency on the topic, as well as on the issue of continuous manufacturing.
•          Medical Device Cybersecurity – The one-year appointment of the University of Michigan’s Kevin Fu as acting director of a new CDRH cybersecurity division is being hailed as a signal that the agency has elevated its treatment of cybersecurity, Shehan says. He projects a cybersecurity guidance will be issued this year.
•          Artificial Intelligence/Machine Learning-Based Medical Software and Digital Health – Shehan says some members of Congress have expressed skepticism about FDA’s digital health plans.
•          Additional Legislation to Follow – Medical device stakeholders should be watching the FDA budget, user fee reauthorizations, and a possible 21^st Century Cares Act 2.0 for some legislative efforts that appear difficult to enact, according to Shehan.