MDIC and FDA: Bring Patient Preferences into the Regulatory Process


On May 13th, the Medical Device Innovation Consortium (MDIC) and the US Food and Drug Administration (FDA) released important reports on incorporating patient preferences into the regulatory process.In its Report, the MDIC encourages device companies, the FDA, and stakeholders to explore patients’ perspectives on the benefits and risks of new technologies and incorporate those data into the regulatory process. Similarly, the FDA’s Center for Devices and Radiological Health MDIC Logo3 180(CDRH) and Center for Biologics Evaluation and Research (CBER) released a draft guidance document on patient preference and the regulatory process.

FDA logo 180The MDIC report was a collaborative effort between MDIC, its member organizations (including the Foundation), staff from the FDA’s CDRH, and other experts. Public comments on the FDA’s draft guidance document will be accepted until mid-August. “These steps by the FDA, and particularly CDRH, demonstrate their commitment to bringing the patient voice into the regulatory approval process,” said Jessica Foley, PhD, the Foundation’s Chief Scientific Officer.

Dr. Foley spoke on a panel at the May 13th special event for the public release of the MDIC framework and shared the Foundation’s view that these important first steps will hopefully allow the voice of the patient to play a more crucial role in access to new therapies such as focused ultrasound. Patient preference data could also be useful in other areas that are critical for patient access, such as reimbursement and physician adoption. The event was attended by 75 people and an additional 150 participated online.