Could Bassinet Clearance Expand FDA Authority? Law Firm Expresses Concern
By clearing Happiest Baby’s SNOO bassinet in March, the US FDA exercised authority over a product that typically would fall within the jurisdiction of consumer product safety regulators. One law firm questions what that might mean for manufacturers of similar products.
You may also be interested in...
The $1,700 infant sleeper is the first device to reach market indicated to help babies sleep on their backs. It was developed by Happiest Baby.
The US agency is warning manufacturers about an alarming device submission trend toward unreliable data generated by third-party labs.
News We’re Watching: CDRH’s Maisel Announces Retirement, Fresenius Clearance, Philips and Smiths Recalls
This week, a device center stalwart prepared to say goodbye; the FDA cleared Fresenius's 5008X Hemodialysis System; and class I recalls for Smiths Medical and Philips Imaging were announced.