Qevatrix

Guide

510(k) submission guide: how premarket notification works

A 510(k) is a premarket notification to the FDA showing that a new device is substantially equivalent to a legally marketed predicate device. Most Class II devices, and some Class I devices, reach the US market this way. Once the FDA agrees, it issues a clearance letter.

The basics

What the FDA is looking for

Substantial equivalence

The device has the same intended use as the predicate, and either the same technological characteristics or different ones that raise no new questions of safety and effectiveness.

Choosing a predicate

Predicates are found in the FDA 510(k) database. A well-chosen predicate with a close intended use and technology makes the comparison far simpler.

Types of 510(k)

The FDA recognises Traditional, Special and Abbreviated 510(k)s. Special 510(k)s suit certain changes to your own cleared device.

eSTAR format

The FDA requires most 510(k)s to be submitted in the electronic eSTAR template, which structures the content and checks it for completeness.

Preparing it

A practical order of work

  1. 1Confirm the device's classification and product code, and that a 510(k) is the right pathway.
  2. 2Select a predicate and build a side-by-side comparison of intended use and technology.
  3. 3Plan and run the performance testing: bench, biocompatibility, electrical safety, software and sterility as applicable.
  4. 4Consider a Pre-Submission (Q-Sub) to get FDA feedback on the testing plan before you run it.
  5. 5Assemble the eSTAR, pay the user fee, and track additional information requests against the review clock.

Where Qevatrix fits

Submissions and clearances in one record

RegulatoryOS pulls your existing 510(k) clearances from FDA databases automatically, tracks Q-Sub history and open submissions, and links each clearance to its device and registrations.

Explore RegulatoryOSTalk to our team

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This guide is an orientation, not regulatory advice. Confirm current requirements, fees and eSTAR rules on the FDA website before submitting.