CDRH touts success in exceeding strategic priorities for 2020

Regulatory NewsRegulatory News | 13 August 2021 |  By 

Just over 60% of novel device manufacturers planned to bring their innovative devices to the US market first or in parallel with other major markets in 2020, according to a strategic accomplishments document released 13 August by the US Food and Drug Administration (FDA) Center for Devices and Radiological Health. The center touted additional accomplishment in meeting its strategic goals for 2020, which include improving employee engagement, increasing simplicity in regulatory processes, and building more collaborations with stakeholders.
In its Strategic Priorities document for 2018-2020, FDA noted that its “rigorous regulatory standards” and an inefficient regulatory framework posed disincentives for providing Americans access to life-saving devices, and that greater employee engagement, increased simplicity in regulatory processes and more outside collaborations would help improve that access.
Among CDRH’s other accomplishments:
  • The center streamlined and modernized 87% of its processes, exceeding its goal of streamlining 80%.
  • The center met goal of collaborating with 10 communities by the end of 2020, then surpassed it by adding two more community collaborations by August 2021.
  • Employee engagement improved to 81%, increasing 4% since 2019 and 15% since 2015.
The agency surveyed device companies on their plans for bringing their device to market, and found the results exceeded targets. FDA’s target in 2020 was to have 50% of manufacturers of novel technologies bring their devices to market in the US. In 2020, 62% of companies surveyed said they intended to bring their innovative devices to the US first or in parallel with other major market.
Novel technologies are devices subject to a premarket approval (PMA) application, humanitarian device exemption (HDE), through de novo pathways, as well as those brought to market through Emergency Use Authorization (EUA), or through the breakthrough devices program.
CDRH Director Jeffrey Shuren, MD,  announced in December 2020 that that the center would extend its strategic priorities for 2018-2020 into 2021 as COVID-19 had “disrupted the trajectory” of the medical device program in 2020 (RELATED: Shuren previews 2021 priorities for CDRH, Regulatory Focus, 3 December 2020).
CDRH 2018-2020 accomplishments
CDRH 2018-2020 priorities


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