Compliance In Focus

The FDA finalized and released their new Guidance For Industry for the 510(k) Third Party Review Program on March 12.

FDA’s Third Party 510(k) (3P510k) Review Program, formerly known as the Accredited Persons Program, allows device manufacturers to submit 510(k) applications for eligible devices to a Third Party Reviewer, who uses FDA criteria to evaluate the submission. Per the FDA, about 50% of the 510(k) submissions the agency receives are eligible for the Third Party Review Program.

With the resignation of FDA Commissioner Scott Gottlieb taking effect this month, many clinical research professionals are wondering how this could impact their drug and device trials. 

During his tenure of just under two years, Dr. Gottlieb introduced a number of initiatives, including one aimed at aggressively regulating teenage vaping, reducing nicotine in cigarettes to non-addictive levels and banning menthol in cigarettes. He also oversaw the approval of a record number of new medicines, generic drugs and medical devices.

Yet his departure leaves many questions unanswered, especially those that impact the medical device industry.

Here are just a few of them.