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.
Texas Medical Technology received a Form 483 from the FDA for a variety of lapses observed during a Feb. 16 to March 3 inspection at its Houston facility, ranging from inadequate device records to ineffective medical device reporting (MDR) procedures. Read More
Leading devicemakers have pushed back against the FDA’s proposed annual appraisals of companies that participate in the agency’s Voluntary Improvement Program (VIP). Read More
The FDA’s annual announcement of planned enhancements to its electronic medical device report (eMDR) portal advises devicemakers that use the agency’s Electronic Submissions Gateway (ESG) to update their submission systems accordingly. Read More
Virpax said it expects to complete stability testing, human factors testing for medical devices, safety studies and supplementary in-vitro studies. Read More