Premarket Notification 510(k)

The Premarket Notification 510(k) is a premarket submission type used in the US that medical device manufacturers must submit to the Food and Drug Administration (FDA). This premarket submission type made to the FDA is meant to demonstrate that the device is safe and effective. Submission is mandatory for any medical device intended for human use unless the device is exempt by regulation or is a Class III device. 

The information required in a 510(k) includes device classification, intended use, proposed labelling, comparison with predicate device, device description, applicable information expiration, biocompatibility, sterilization, performance testing, etc. 

How does structured content authoring help? 

Authoring and reviewing are important steps in creating the 510(k). As the document moves for approval, from one person to another, either within or outside the organization, the process is prone to error. 

A structured content authoring (SCA) tool can help reduce errors by offering granular access to reviewers to edit only certain parts of the document and industry-specific taxonomies can be imported and used for accurate and approved term use. This way, the document owner can have 100% control regarding who does what, when, and where – eliminating errors and reducing time-to-market for the entire organization.