A 510(k) is an FDA premarket submission showing a medical device is substantially equivalent to a legally marketed predicate, required for most Class II and some Class I devices before U.S. marketing.
The 510(k) process is the workhorse of medical device clearance in the United States. A 510(k) premarket notification is the mechanism through which most Class II and some Class I devices obtain regulatory clearance before they are marketed. Submitting a 510(k) shows that a new device is substantially equivalent to a legally marketed predicate device. Substantial equivalence means the new device has the same intended use and either the same technological characteristics as the predicate or different technological characteristics that do not raise new safety or effectiveness questions. Manufacturers must provide comparative data on design, materials, performance, energy sources, biocompatibility and labeling.
A wide range of entities must submit a 510(k): U.S. manufacturers, specification developers, repackagers and relabelers who significantly change labeling, and foreign manufacturers introducing devices into U.S. commerce. Most Class II devices require a 510(k), while Class I devices are generally exempt and Class III devices require a Premarket Approval (PMA). A new 510(k) is required whenever modifications could affect safety or effectiveness. Conversely, pre‑amendment devices (marketed before 28 May 1976), devices exempt from 510(k) by regulation, and devices cleared through other pathways (e.g., PMA or De Novo) do not require a 510(k) as long as there are no significant modifications.
Understanding the purpose of a 510(k) prevents missteps. The FDA does not test devices prior to clearance; instead, reviewers evaluate whether your evidence supports substantial equivalence. Submitters must present complete data—promises to complete testing later are rarely accepted. Key elements of a submission include a cover letter and administrative details, a 510(k) summary, indications for use, a detailed device description, predicate comparison, verification and validation testing, risk analysis, biocompatibility and sterilization information, labeling and declarations of conformity to recognized standards. A well‑documented predicate comparison demonstrates that differences in technology do not raise new questions of safety or effectiveness.
When preparing a 510(k), consider whether modifications may be covered by special or abbreviated 510(k) pathways. Special 510(k)s apply to design changes to the manufacturer’s own device that do not affect intended use or fundamental technology; abbreviated 510(k)s rely on FDA guidance and recognized standards to reduce documentation. Using the FDA’s eSTAR template ensures all required elements are addressed and the electronic copy (eCopy) meets formatting specifications. Most importantly, maintain consistent language for intended use and indications across all documents to avoid Refusal to Accept (RTA) letters.
By understanding who must submit, when a 510(k) is required and what evidence the FDA expects, you lay the foundation for a strong regulatory strategy. Subsequent pages in this series provide guidance on classifying devices, selecting predicates, compiling documentation and navigating testing requirements.
