What a new FDA commissioner could mean for clinical research
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.
What will become of the 510(k) program?
In November 2018, in a joint statement with Dr. Jeffrey Shuren, the director of the Center for Devices and Radiological Health, Dr. Gottlieb announced that the FDA would be proposing certain changes to the 510(k) program for approving medical devices.
The current 510(k) program has been in place since the 1976 Medical Device Amendments and allows devices to be considered for approval if they are “substantially equivalent” to previously approved devices. The FDA has made a number of changes to this program in recent years, including:
Increasing premarket expectations for 510(k) submissions
Implementing a policy refusing to accept incomplete submissions
Moving toward eliminating the use of the 510(k) programs for Class III medical devices on the market prior to 1976
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Source: Mass Device - Category: Medical Devices Authors: Danielle Kirsh Tags: Blog IMARC Source Type: news
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