Module 15 2022

19/05/2022

Planning

De novo 510k

Claims, Risks & Benefits Reimbur sement

I nv. D evice E xempt.

Q-subs:

Use of OUS data

PMA

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 7

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Guidance that help clinical strategic thinking: Least Burdensome Provisions

1. The right information should be provided at the right time to address the right questions.

2. Regulatory approaches should be designed to fit the technology , taking into account its unique innovation cycles, evidence generation needs, and timely patient access. 3. FDA intends to leverage data from other countries and decisions by, or on behalf of, other national medical device regulatory authorities to the extent appropriate and feasible.

https://www.fda.gov/regulatory information/search-fda-guidance documents/least-burdensome provisions-concept-and-principles

The Organisation for Professionals in Regulatory Affairs

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