How to work with the new FDA

Here’s how medical device makers can capitalize on the strategic priorities and transparency initiatives at FDA’s CDRH.

Lisa Olson, RCRI

Scott Gottlieb has now settled into his role as FDA’s new commissioner and is putting his stamp on the agency.

Interestingly, he has started with some very specific points of focus that have bubbled to the surface in the political arena, including the drug approval process and tobacco and opioid addiction.

On the working level, Gottlieb’s appointment has not interrupted the momentum of the agency as a whole. When the totality of FDA actions and external communications are evaluated, the agency is still demonstrating a focus on the strategic priorities set out in 2016. Although the recently signed fourth iteration of the Medical Device User Fee Act (MDUFA IV) has several new points, all of the changes serve to support the 2016 initiatives.

Strategic priorities

The initial priorities set forth in 2016 focused on three main topics:  establishing a national evaluation system, partnering with patients and promoting a culture of quality and organizational excellence. For 2017, the agency went deeper by defining how they intended to support those initiatives with the Regulatory Science Priorities document. These priorities ranged from the use of big data in decision making to the development of new evaluation tools. There are tactical points for safety evaluations and controlling the microbial risks in reprocessed and sterile devices. Notably, these are all externally facing initiatives. However, FDA is honoring its commitment to improvement, transparency and accountability through their highly detailed quarterly reports.

Get the full story on our sister site, Medical Design & Outsourcing.

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