Update on FDA Strategies regarding Medical Devices

The FDA Center for Devices and Radiological Health (CDRH) has published its strategic goals on medical devices for 2013 in a document entitled "2013 Strategic Priorities" (see GMP News: FDA's Strategies on the Regulation of Medical Products: How do they look like?).

The FDA recently released a position determination and further development of these strategies. After a Director of Technology and Innovation had been appointed based on the strategic priorities in order to push the development of medical devices, the FDA also published a "Medical Device Innovation Initiative White Paper." Furthermore, with the participation of the FDA and industry various initiatives were initiated with the goal of bringing innovative medical devices to the market. These initiatives currently include:

  • Streamlining clinical studies 
  • Accelerating FDA approval 
  • Determining the correct relationship between pre- and post-market requirements

The experience from these initiatives was also incorporated in an updated strategy paper of the FDA.

You can find the entire report on the FDA website.

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