On Thursday, September 22nd, the FDA’s Center for Devices and Radiological Health (CDRH) released its regulatory science priorities for fiscal year 2017.
According to CDRH, regulatory science is aligned with and supports both its mission and vision. In addition, the Center states that it feels regulatory science “must be proactive and anticipate regulatory and public health issues, while also being responsive to emergent issues.”
The Center’s “regulatory science priorities serve as a catalyst to improving the safety, effectiveness, performance and quality of medical devices and radiation-emitting products and to facilitate introducing innovative medical devices into the marketplace.” These priorities are identified on an annual basis and are reassessed and updated periodically to reflect the current needs. Furthermore, CDRH states that its regulatory science priorities are intended to serve as a guide for making strategic decisions regarding intramural research funding. This helps to “ensure that CDRH research is focused on needs that are relevant and critical to medical devices and radiation-emitting products.”
Using the feedback provided from CDRH staff and senior leadership, the 2017 priorities were identified by the Regulatory Science Subcommittee (RSS) under the direction of the Center Director and the RSS co-chairs. CDRH states that it used the following approach in developing its priorities:
In addition, the Center also notes that the “regulatory science needs were assessed for their regulatory and public health impact using the following criteria:
The following are CDRH’s 2017 regulatory science priorities:
June 23, 2020
The submission of your drug application (NDA, ANDA, BLA, etc.) is an exciting accomplishment, and one of the first major milestones is a pre-approval inspection (PAI) of the manufacturing sites...
June 1, 2021
Recent recalls of dozens of lots of the front-line blood pressure and heart medications including valsartan, losartan, and irbesartan are placing the spotlight on impurities in generic drugs. After...
February 18, 2021
As the dust settles on the final Brexit deal, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is forging new opportunities to innovate, increasing its efficiency, and...