Bringing Innovative “Healthy” Consumer Products to Market - Webinar Recording/ Transcript
Bringing Innovative “Healthy” Consumer Products to Market: Understanding the Evolving FDA Framework to Remain On (or Off) the Road to Regulatory and Market Success
Deep within the still-new 21st Century Cures Act lies a clause that could alter FDA medical device regulation in ways no one can yet know ... and have implications far beyond companies now subject to FDA regulation.
That clause, Sec. 3060, redefines “medical device” to exclude significant software functions. In doing so, it may limit FDA regulation of consumer products when they are associated with health and wellness claims — products such as smartwatches that can measure bodily functions.
How will your products — not to mention products you may develop in the future, from “smart” monitors to wearables to ??? — be affected?
The FDA plans to issue guidances, possibly in the coming quarter, clarifying how it sees its authority changing under Sec. 3060. Will your profits suffer ... or benefit? You need answers now.
Michael M. Gaba Esq. starts with the FDA’s risk-based classification system that has been in place for decades, then invites you to look into his crystal ball:
- How the 21st Century Cures Act may set new limits on the FDA’s authority by redefining “medical device” to exclude significant software functions
- What the agency must do to harmonize its guidance with current law and how this could affect your regulatory decision-making in the interim
- The urgent need to re-evaluate existing and planned products for which you make health and wellness claims
- And much more!
Sec. 3060 has the potential to remake medical device regulation, as well as bringing many companies under FDA regulation for the first time. Whether you face FDA regulation now or envision it down the road, the time to get up to speed is right now.