We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA issued a final guidance explaining its current policy on when agency staff may refuse to consider device companies’ applications for 510(k) clearance of a new product. Read More
The FDA has handed Microbiologics a Form 483 for not reporting device recalls and not properly documenting process controls, following an inspection of the company’s facility in Saint Cloud, Minn., in November and December. Read More
A consumer of lidocaine patches sold by Target has filed a class-action lawsuit against the retailer, claiming that the devices don’t stick to the skin and aren’t strong enough. Read More
Developers of devices that are intended to improve glycemic control in patients with type 2 diabetes should conduct an early-stage feasibility and safety study to support additional trials that further hone in on feasibility, the FDA said in a final guidance. Read More
The FDA issued ProTom International a Form 483 with eight observations following an inspection of the company’s manufacturing plant in North Reading, Mass., last December. Read More
The FDA’s Center for Devices and Radiological Health is proposing to issue an order requiring Philips Respironics to submit a plan to repair, replace or refund the purchase price of a range of recalled respiratory devices that it manufactured after November 2015. Read More
The FDA released a revised guidance clarifying when device sponsors that make certain low-risk product changes may not have to submit supplements for already approved premarket approvals (PMAs) or humanitarian device exemptions (HDEs) during the COVID-19 public health emergency. Read More