EVERBIZ | Original compilation. Please credit the source when republishing.
For medical device manufacturers preparing to enter the US market, the first question about any regulatory news item is: does it introduce a new requirement, or does it describe an existing system?
This item is a reminder of how US market access for medical devices works.
01 The core is demonstrating substantial equivalence
FDA defines the 510(k) as a premarket submission intended to demonstrate that the device to be marketed is substantially equivalent (SE) to a legally marketed predicate device. The legal basis lies in Section 513(i) of the Federal Food, Drug, and Cosmetic Act.
Choosing a predicate is only the starting point. The submission must also explain whether the intended use is the same and whether the technological characteristics are the same; where they differ, whether the differences raise different questions of safety and effectiveness, and whether the evidence supports a finding of substantial equivalence. Substantial equivalence does not require the devices to be identical.
A similar appearance, a similar name or the use of similar technology cannot replace a complete comparison backed by evidence.
02 Submitting a notification does not mean you can sell
“Premarket notification” may sound like a simple filing, but FDA is clear: a device subject to 510(k) may not be marketed until FDA has issued a written decision finding it substantially equivalent.
This outcome is usually called 510(k) clearance, which should not be confused with Premarket Approval (PMA).
Likewise, “submit at least 90 days in advance” does not mean “automatically cleared after 90 days“. FDA’s overview mentions the advance notice requirement, but commercial launch still depends on receiving the decision.
03 Device classification determines the pathway
According to FDA, some Class I and most Class II devices require a 510(k). Some Class I and Class II devices are exempt, but only within the applicable limitations of exemption. Other US pathways, such as PMA and De Novo, also exist, so the 510(k) is not a universal entry route.
Devices already on the market need attention too. Changes in design, materials, chemical composition, energy source, manufacturing process or intended use that could significantly affect safety or effectiveness may trigger a new 510(k).
Regulatory assessment should run through product development and post-market change management.
04 Three practical steps
The following are practical recommendations based on the official requirements above, not new regulatory obligations.
- Confirm the pathway: establish the device classification, product code, regulation number and any exemption limitations before deciding whether a 510(k) applies.
- Review predicates and evidence: use FDA databases to identify candidate predicates and assess intended use, technological differences and evidence needs from public documents, rather than judging comparability from search results alone.
- Check changes and launch plans: keep documented assessments for product changes, and make the FDA decision a key condition in your launch planning.
A page being indexed, a web page being updated and a regulatory obligation changing are three different things that each need to be verified. Identifying the nature and date of a document correctly lets companies focus their resources on the compliance actions that really matter.
How EVERBIZ Can Help
EVERBIZ supports medical device manufacturers with US FDA market access, including pathway assessment, predicate research and 510(k) preparation. Contact us for a one-to-one consultation.
This article is a compilation of regulatory information and does not constitute legal advice. Official FDA documents prevail.
EVERBIZ | Original compilation. Please credit the source when republishing.