DuVal & Associates

FDA

DuVal & Associates is a Minneapolis-based law firm focused on FDA-regulated products. Its medical device work includes regulatory strategy, 510(k) and other submission advice, communications with FDA, inspection and enforcement matters, and review of labeling and promotion. The team combines legal counsel with experience in regulatory, quality, clinical and commercial issues affecting device and technology companies.

Learn more

Are there FDA requirements for non-device clinical decision support software?

Anonymous · 1 comment

5 months ago

According to the new FDA guidance on clinical decision support software, our software is classified as a non-device. What are the requirements for bringing such software to the US market? Are there st

Accepted 1 answer

If your assessment shows that your product is truly a “non-device” according to the FDA guidance, there aren’t specific FDA requirements you need to m

What is my company's role under MDR when incorporating a CE-marked software medical device from another manufacturer into our non-medical app?

Anonymous · 2 comments

8 months ago

I am planning to incorporate a CE-marked software solution (manufactured by another company) into our app, which itself is not a medical device. The software will be made directly available to our use

Accepted 2 answers

We were in a similar situation and the competent authorities defined our role as a distributor. If you are making the CE-marked software medical devic

FDA Compliance

The Ultimate Comparison: ISO 13485 vs. FDA 21 CFR

Updated about 1 year ago

Sebastian Skorka