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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:
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.
This presentation will be of interest to anyone who now makes health or wellness claims or may do so in the future — including companies that do not now face FDA regulation. Devicemakers, software developers, companies developing technologies aimed at consumer products ... they’re all fair game. Specific job titles include:
Michael M. Gaba Esq., Vice Chair, FDA Practice Group, Polsinelli PC, provides strategic regulatory, reimbursement and public policy counsel to device and biotech manufacturers. Working with your legal and business teams to maximize compensation, he draws on 20+ years of resolving Medicare coverage, coding, and reimbursement disputes with the FDA and the Centers for Medicare and Medicaid Services (CMS) and the FDA.
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