What are the current regulations on health wearables?

What are the current regulations on health wearables?

Health wearables are regulated by various agencies, primarily the FDA in the U.S. They classify devices based on risk.

What types of health wearables are considered medical devices?

Devices that diagnose, treat, or prevent medical conditions, like heart rate monitors and glucose monitors, are classified as medical devices.

Are there any specific compliance requirements for manufacturers?

Yes, manufacturers must comply with quality system regulations, conduct clinical trials, and ensure data privacy.

How do these regulations affect consumer access to wearables?

Regulations can limit access to certain devices until they are approved, but they also ensure safety and efficacy for users.

What future changes can we expect in these regulations?

Future changes may include more streamlined approval processes and updated guidelines for data privacy and security.