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The FDA on Friday issued a draft guidance on its Voluntary Improvement Program (VIP), which uses third-party quality appraisals to help manufacturers improve their production and quality practices, signaling VIP’s transition from a pilot to a permanent program. Read More
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 multiplex test will help address increasing rates of sexually transmitted infections (STIs), after disruptions in care during the pandemic contributed to a decline in routine STI screening, the company said. Read More
SpineX previously received a Breakthrough Device designation for treatment of neurogenic bladder, an incurable condition in which the relationship between the nervous system and bladder function is disrupted by injury or disease. 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