New guidance from the US Food and Drug Administration revises financial disclosure requirements made by medical device clinical study sponsors to clinical investigators.
The revised guidance comes following recommendations from the US Department of Health and Human Services’ Office of Inspector General that the FDA should ensure that sponsors provide complete financial information regarding all their clinical investigators; that relevant agency personnel consistently review financial information; and that clinical study sponsors submit financial information for their clinical investigators before studies begin.
Among requirements outlined in the guidance:
Financial interests covered by the guidance include:
Although sponsors are not required to provide financial disclosure information to the FDA until they submit their marketing applications, they must collect such information from their clinical investigators before the investigators participate in clinical studies, such as during an FDA Pre-Submission or Pre-IDE consultation.
Failure to comply with financial disclosure requirements could result in the FDA refusing a sponsor’s marketing application. In addition, the regulator has the authority to audit data from clinical investigators, request additional data analysis from the sponsor, or request that the sponsor undertake additional studies to confirm results.