Who You Gonna Email? Digital Health Question Busters!

Though digital health is not new, it can still often be difficult to determine with precision the regulatory requirements applicable to a particular software product. Sometimes this is because FDA has not opined on a specific set of facts, but more often it is because FDA seems to take different approaches to the same technology offered by different companies. This can be for a variety of reasons, but often comes down to whether the company chooses to ask forgiveness rather than permission.

For example, many large tech companies market software products with heart rate and other vital signs monitors, and do not ask permission beforehand. Smaller companies, however, may have requests from board members and investors to provide confirmation from FDA that their approach to product regulation is correct and in alignment with FDA requirements. The question is how best to go about doing so. Some companies will submit 513(g) requests. Others submit pre-submissions. Both of these options require extensive preparation time and wait time to receive a response. For 513(g)s, FDA has no mandatory response time, so the submitter can, in some cases, wait six months or more for a response, plus there are user fees associated with 513(g)s. For pre-submissions, it is approximately two months before receiving a response from FDA. When a company has a relatively straightforward question, and a board in need of answers, these options may not be viable.

One other option that is used less often is a direct inquiry with FDA’s Digital Health office. If you submit inquiries to DigitalHealth@fda.hhs.gov, the digital health team can provide general feedback about digital health inquiries, such as “how does FDA think about artificial intelligence.” It can also provide feedback about a specific product, if the submitter includes information about the intended use, functionality, and desired marketing claims. The team tries to respond to inquiries within two weeks, and will hold a call with the submitter if requested. This can be an easier, faster option to facilitate important decision-making, particularly during the early stage of product development.

If you have questions about the status of your digital health product-or that of a competitor-please reach out so that we can help you get answers in a timely manner.