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FDA’s Strategic Policy Roadmap for 2018

FDA Commissioner aims to streamline review and beef up technical support

FDA Commissioner Scott Gottlieb, MD laid out an 18-page "roadmap" for achieving the FDA’s 2018 goals and objectives. The broad sweep of initiatives addresses four main objectives: reducing opiod and other addictions, leveraging innovation and competition, empowering consumers and strengthening FDA’s scientific workforce.

Under the empowering consumers banner, Dr. Gottlieb says the FDA will take new steps in 2018 to adapt traditional approaches to regulation to better fit new technologies such as digital health tools. He noted that the FDA’s Pre-Certification Pilot Program is one of the efforts aimed at adapting review and approval to the highly repeated cycles of innovation that characterize such digital health tools.

The Pre-Cert pilot program aims to develop a more tailored approach to accommodate the rapid pace of digital innovation, while taking a risk-based approach to the Agency’s oversight of these innovations.

He notes that as the FDA is asked to review more complex and specialized technical devices it will require personnel with enhanced technical knowledge and expertise. To that end the agency will be recruiting and hiring staff able to keep pace with the dramatic advances in science and medicine.

In terms of leveraging innovation, Gottlieb’s roadmap listed 5 bullet points with regard to new medical devices:

  • Adopt a team-based approach to the regulation of medical devices that takes a lifecycle view of new products.
  • Install a new Total Product Life Cycle Office in CDRH to establish an agile infrastructure that adapts to future regulatory and scientific needs created by new technologies and minimizes organizational layers of review throughout the device life-cycle, achieving more efficient work processes and allowing employees to better leverage their knowledge of pre- and post-market information to optimize decision-making.
  • Advance a new approach to the review of medical device submissions through an alternative 510(k) pathway and a new framework to balance pre-versus post-market requirements targeted to significant unmet medical needs.
  • Advance a comprehensive plan to promote device safety using new tools and approaches to pre- and post-market oversight.
  • Develop and advance the use of in silico (computer simulation) tools and models to evaluate device performance and patient outcomes as part of the Medical Device Innovation Consortium. 

In summarizing his initiatives, Dr. Gottlieb noted that they are all interrelated.

“While these areas are presented as separate concepts, like much of our work and our mission, the ideas embodied in these priority areas are not independent of each other,” he wrote. “There are areas of overlap both between these priorities and with other aspects of our work at FDA. Achieving all of these goals will be reciprocally reinforcing, and complement other aspects of our mission.”

 

Keeping abreast of FDA and other regulatory agency initiatives can be time consuming. As your partner in innovation Kapstone Medical continually monitors regulatory requirements and changes to the approval pathways.

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