510k
What is a 510k?
A 510k, or a premarket notification (PMN), is a part of the FDA medical device approval process. It is the most common submission pathway.
There are three types of 510ks:
- Traditional 510k: used for an original 510k or change to a device previously cleared under 510k
- Special 510k: used for submission of changes to an existing device if the method(s) to evaluate the change(s) are well-established and results can be sufficiently reviewed in a summary or risk analysis format
- Abbreviated 510k: used when the submission depends on FDA guidance document(s), demonstration of compliance with special control(s) for device type or voluntary consensus standards
There are five steps in the 510k application process:
- Research
- Review product classification codes of predicate products
- Consolidate information & FDA 510k application data
- FDA 510k review
- Final FDA 510k clearance approval
Why are 510ks important to healthcare?
510ks are important to healthcare because they ensure medical devices on the market and in use by healthcare providers are safe and effective. In turn, 510ks lead to better patient care and outcomes.