Special 510(k) check

You changed your own cleared device. FDA's Special 510(k) Program reviews some changes in 30 days instead of 90. Answer four questions to see whether yours looks like a fit, and why.

Is the change to your own legally marketed device?

The device you already market, cleared under your name, not a competitor's or a new device.

Yes No

Does the change alter the indications for use? Yes No

What testing does the change need? None: the change needs no new performance data Testing by well-established methods (recognized standards, methods used before) New or non-standard test methods Clinical data

Could FDA review the results as a summary or in a risk-analysis format?

For example, a declaration of conformity to a standard plus a summary of results, rather than full test reports.

Yes No Not sure

A screening aid, not a determination. The answer follows FDA's published guidance and cites it, but only FDA decides, through a Pre-Sub, a 513(g) or the submission itself. Confirm with FDA or a qualified regulatory professional. Fees and review goals are planning figures. Nothing you answer is saved.

Before you use it

First decide whether the change needs a new 510(k) at all. FDA's change guidance walks through that, and when it doesn't, the outcome is a documented rationale (a letter to file), not a submission. Traditional, Special or Abbreviated 510(k) explains the three in plain terms.

Other free tools: Special 510(k) · De Novo · 513(g) · Breakthrough · classification lookup · predicate search · Learn

Regulatory Copilot

The eQMS with the regulatory brain, built for device startups and the consultants who guide them.

Regulatory Copilot is a documentation and workflow tool; it does not provide legal or regulatory advice or guarantee any FDA outcome. Fees, timelines, and requirements shown are illustrative planning estimates. Confirm current requirements with FDA and a qualified professional.