The FDA Plans to Alter its Rules to Help Facilitate Innovation in Medical Device Development

The U.S. Food and Drug Administration (the “FDA”) has announced in a press release that the agency and other regulatory representatives will participate in a one day workshop entitled “Indentifying Unmet Public Health Needs and Facilitating Innovation in Medical Device Development.” Dr. Jeffrey E. Shuren, director of the Food and Drug Administration’s Center for Devices and Radiological Health, announced that the goal of the agency will be to overhaul its procedures to speed innovation while protecting patient safety.

This workshop comes after complaints about poor communication and delays in reviewing and approving new medical devices by medical device executives and other industry profession. Specifically, after taking years to develop necessary medical devices that will help prevent, diagnose, treat, and monitor serious and life-threatening diseases, these devices undergo a protracted regulatory review process before entering the market place. It then takes yet additional time for these devices to be adopted into clinical practice and for patients to realize the benefits.

The initiatives expected to be discussed for revamping the FDA’s approval process for medical devices, including changes to the development of clinical trials will be released to the public in the coming weeks. Any new procedures could take effect later this year.

For more information on this topic, feel free to call Carey F. Kalmowitz, Esq. or Adrienne Dresevic Esq. of The Health Law Partners at (248) 996-8510 or (212) 734-0128.