Stemming from the much anticipated Medical Device User Fee & Modernization Act (MDUFMA), FDA issued a new guidance regarding Premarket Approval Applications (PMAs) review and approval timelines. As the guidance plainly states in the introduction “the additional funds obtained from user fees will enable FDA, with the cooperation of industry, to improve the device review process to meet certain performance goals and implement improvements for the medical device review process.”

Conflict of interest can be defined as occurring when an individual or organization is involved in multiple interests, one of which could possibly corrupt the motivation for an act in the other.  Per the regulations, most clinical trials require disclosure of conflict of interest (COI). This is required by the investigator(s) to the sponsor, then from the sponsor to the FDA. The FDA then considers whether adequate steps are taken in the design, conduct, reporting and analysis of studies to minimize bias.