With the new year, it is time to provide a forecast of the legislative and regulatory landscape.

In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical ...

FDA plans limited regulation of wearable medical devices, boosting Apple, Fitbit, Oura stocks as 50% of Americans use fitness ...

FDA nonmedical wearable health data devices providing general health info will not face regulation, clarifying guidance for ...

The FDA will ease regulation of digital health products, aiming to deregulate AI and promote its widespread use.

The Food and Drug Administration (FDA) updated its guidance on Tuesday to allow more wearables to fall into a general ...

As FDA medical device lawyers advising AI and digital health companies, Hogan Lovells lawyers have had a front-row seat to an increasingly common scenario: software platforms and mobile apps that ...

The U.S. Food and Drug Administration (FDA) plans to rescind its laboratory developed test (LDT) rule dated May 6, 2024. The rule would have regulated LDTs as in vitro diagnostic products (IVDs) and ...

Government regulations affect drug development, often prolonging the process, but they ensure safety and efficacy to protect ...

FDA’s decision to limit regulations of non-medical grade wearables marks a notable shift toward regulatory restraint in digital health. FDA announced its plan to stop subjecting non-medical grade ...

As promised in its FDASIA report, the FDA has published a draft guidance document that aims to help those creating wellness devices and apps to better understand when their product (or their marketing ...

If you care about food safety, then Jim Jones matters to you. A year into his tenure as Deputy Commissioner for the Human Foods Program, Jones has infused the FDA food programs with a new sense of ...