top of page
4 min read
Tips and Tricks for Responding to a Form FDA 483 to Best Avoid a Warning Letter
FDA’s Office of Regulatory Affairs (ORA) is the lead office for all field activities, including inspections and enforcement. During an...
2 min read
Laboratory Developed Tests
The FDA defines Laboratory Developed Tests (LDTs) as “in vitro diagnostic products (IVDs) that are intended for clinical use and are...
1 min read
510(k) Clearance Process for Medical Devices
The 510(k)-review pathway can be used to obtain FDA clearance for a moderate to low-risk device when a predicate device is established.
bottom of page