NuVasive Inc. is marketing its Precice specialized orthopedic devices made of titanium once again after voluntarily pulling them from the market in April over concerns about the safety of the steel-based version of the product. The firm also initiated a recall to address changes in the instructions for use for titanium Precice.

Invacare, Smiths Medical and CellEra were cited for quality systems and Medical Device Reporting violations in the only device-related warning letters released by the agency last month.

Manufacturers can’t use the US FDA’s voluntary eSTAR product submission program for de novo requests until January – but they can start practicing now on how to use eSTAR for that review pathway.

For five years Owlet Baby Care Inc. has said its Smart Sock monitoring product isn’t a medical device. But the US FDA disagreed – and finally put its foot down in a warning letter that told the company to come into compliance or stop selling the sock. So Owlet decided to do both.

The number of recalled device units ballooned to a whopping 372,215,986 in the third quarter of 2021, mostly driven by an August recall of Monoject Flush Prefilled Saline Syringes by Cardinal Health. Check out our Q3 recalls infographic.

The US FDA says in a report that its Inspectional Affairs Council will develop Remote Regulatory Assessment policies for all commodities the agency oversees. RRAs were launched by the FDA as a way to check on a firm’s regulatory compliance without sending an investigator on-site.