A quick summary of 5 recent FDA guidance documents - Aug 2023

Understanding FDA's expectations and linkages to risk management.

The US FDA frequently issues guidance documents¹ for the industry and its own staff to clarify expectations and approach to regulatory decision making. In theory, these guidance documents are not legally binding. However, it is smart to follow all applicable guidance documents if you want to do business with the FDA, and achieve a favorable outcome for your medical device!

There is a lot going on in the medical device industry! It can be overwhelming to keep up with so many guidance documents issued by the FDA to understand the agency’s evolving regulatory approach. This article provides a brief summary of 5 guidance documents issued during the last 90 days, and how they might relate to your risk management process.

1. Content of premarket submissions for device software functions

2. Off-the-shelf software use in medical devices

3. Qualification of medical device development tools

4. Patient-matched guides to orthopedic implants

5. Requests for feedback and meetings for medical device submissions: the Q-submission program

Let us dive in!