The CDRH has released their new strategic priorities for 2014. They will focus on three different areas of improvement with specific goals and deadlines for each area. Their overall goal is for patients to have access to safe and effective medical devices as soon as possible. To accomplish this goal they are looking to make improvements that would encourage medical device developers to choose the US as the first choice country for their device. The CDRH is looking to make the biggest changes in regards to IDEs and PMAs. They wish to reduce the number of IDEs that require more than two cycles and reduce the time to achieve full IDE approval. As for PMAs, device types which require a PMA and have been on the market will be reviewed to ascertain if some of the data requirements should be moved to postmarket or if the devices should change to a lower classification altogether.
The three priorities they have selected are to:
- “Strengthen the clinical trials enterprise;
- Goal: Improve the efficiency, consistency, and predictability of the IDE process to reduce the time and number of cycles needed to reach appropriate IDE full approval for medical devices, in general, and for devices of public health importance, in particular.
- Goal: Increase the number of early feasibility/first-in-human IDE studies submitted to FDA and conducted in the U.S.
2. Strike the right balance between premarket and postmarket data collection;
- Goal: Assure the appropriate balance between premarket and postmarket data requirements to facilitate and expedite the development and review of medical devices, in particular high-risk devices of public health importance.
3. Provide excellent customer service.”
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