Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Insider, in “A Husband-Wife Duo Turned the $1,700 Snoo into the Holy Grail of Parenting, But Some Say They Run Their Company Like a Dysfunctional ‘Surveillance State,’” by Kate Taylor and Jake Swearingen. (Read the full version – subscription required.)
Following is an excerpt:
Karp has spent years pushing for the FDA to certify that the Snoo prevents SIDS. In October 2020, Happiest Baby announced that it had been “accepted” into the FDA’s Breakthrough Devices Program, intended to fast-track approval for inventions that might be lifesaving. Karp hyped the announcement, tweeting in October 2021: “We’re grateful SNOO is the first bed FDA has called a BREAKTHROUGH that might reduce SIDS!”
“But experts note that since the Breakthrough Devices Program began in 2015, 728 devices have been granted the designation; only 56 have received FDA clearance. That means 92% of “breakthrough devices” — including the Snoo — are stuck in the pipeline. According to Bradley Merrill Thompson, a lawyer who specializes in FDA issues, any device that’s been under review for over two years has hit significant roadblocks.”