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.

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

Anonymous · 1 comment

6 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

9 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

Why can some US-marketed health software claim disease risk without FDA medical device approval?

Anonymous · 2 comments

6 months ago

I have seen a company marketing its software product in the US, making statements about disease risks (for example, providing cardiovascular or cancer risk scores) directly to consumers. However, they

Accepted 1 answer

The FDA decides if software is a medical device based on its intended use and the specific claims it makes. Here are some reasons why a product might