The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
An FDA warning letter issued to a researcher involved in clinical trials of the first home HIV test is not expected to affect the product’s marketing, officials from the FDA and the test’s manufacturer said. OraSure Technologies’ OraQuick HIV home test was approved by the FDA last month and is expected to hit retail outlets nationwide in October. Devices & Diagnostics Letter