Hardware Podcasts

How will Emergency Use Authorization (EUA) during Pandemic Influence Future FDA Policy Changes?

Global Medical Device Podcast · 9 Dec 2020 · 39m · Episode 171

What this episode covers

David Pudwill, Senior Director of Regulatory Affairs at ConvaTec and host of the 'Mr. Regulatory' channel, discusses how the FDA's Emergency Use Authorization (EUA) response to the pandemic is reshaping future medical device policy. Pudwill, a former FDA reviewer, predicts that lenient policies for digital health and remote clinical monitoring will likely become permanent, while the agency pushes for harmonization between US CFR Part 820 and ISO 13485 quality standards. He advises manufacturers to submit 510(k) applications early to secure priority review status before the public health emergency ends.

Most relevant to

large enterprises

Topics

Mentioned

Companies
ConvaTec, Green Light Guru, Saint Jude Medical, FDA
Also
ISO 13485, CFR Part 820, 510(k), De Novo

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