MedWatch

FDA-rules could stand in the way of app-development

When app-developers, in-experienced in the medical equipment-business, undertake the development of medical apps, they could fall victim to FDA-rules about the approval of medical equipment.

Foto: Andreasen Carsten

When a Danish software company some time ago presented its newest medical-app for smartphones to CEO of sales and innovation in Scion DTU, Martin Stenfeldt, he asked the company what considerations they had made concerning a 510k-approval. The answer was stunned silence.

The Danish app-developers had no clue that their new invention was likely to be so smart, that American health authorities would classify the app as a medical device and demand a so-called 510k-approval before it could be marketed. And that is the case for a number of smaller Danish software companies, which are great at developing apps, but lack experience in dealing with medical equipment.

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