FDA 510(k) Consulting

  As FDA 510k consultants we can file an FDA 510(k) submission for your Class II medical device or IVD (In Vitro Diagnostics) with the Food and Drug Administration. What is an FDA 510k? A 510(k) is a premarket notification submission made to FDA to demonstrate that the medical device to be marketed is at least as safe and effective, that is ‘substantially equivalent’ (SE), to another... READ MORE

To obtain 510k approval from the FDA we have determined that the following approach is the most efficient and cost effective for our clients, since it dramatically increases the probability of a successful FDA 510k submission. The first step to ensure a successful FDA 510(k) submission is to perform a pre 510(k) gap analysis. During this phase our 510k consultants evaluate the classification... READ MORE

An FDA 510(k) Premarket Notification is a document containing information required under 21 CFR 807 Subpart. It is based on the concept of substantial equivalence (SE) to a medical device legally marketed in the USA (or predicate device). An FDA 510(k) Premarket Notification provides a comparison between the medical device to be marketed and the predicate device or devices.  What is... READ MORE