Summary
The U.S. Food and Drug Administration (FDA) announced it will ease regulations on wearable devices like smartwatches and fitness bands. This change will help these devices come to market faster by not requiring the same long approval process needed for medical-grade equipment. Industry leaders discussed the implications of this decision at a Newsweek event.
Key Facts
- The FDA will reduce regulations on consumer wearable devices to speed up their market availability.
- This decision was announced on January 6 and affects devices such as Apple Watches and Fitbits.
- The move allows certain wearables to skip the lengthy review process required for medical-grade devices.
- Industry panelists at a Newsweek event debated the pros and cons of this regulatory change.
- Concerns were raised about ensuring reliable "post-market surveillance" to safeguard clinical integrations.
- The demand for wearables is rising, with nearly one-third of Americans owning such devices.
- AI advancements have accelerated the development of sophisticated wearable technology.
- FDA Commissioner Marty Makary confirmed that devices providing simple information can bypass regulation unless they claim medical-grade accuracy.
