FDA – Medical Devices
510(k) and Premarket Consulting
Fee: Request a quote
FDA divides devices into three classes by risk: Class I is subject to general controls only, Class II to special controls, and Class III to premarket approval (PMA). For devices that are not exempt, a 510(k) notification is submitted at least 90 days before the device is marketed. The De Novo pathway is available for low- and moderate-risk devices with no existing equivalent.
Who Is Obligated?
Manufacturers bringing a new device to the US market or making a significant change to an existing device.
What We Do
- We determine your device’s class and the appropriate submission pathway.
- We research predicate devices.
- We support the preparation of the 510(k) file and correspondence with FDA.
What You Receive
- Classification and submission pathway report
- Roadmap for the submission file
Medical Device 510(k) and Premarket Consulting Application
Device, intended use and testing details so we can determine your device's class, submission pathway and predicate device and start the 510(k) file.
Frequently Asked Questions
- Does my device need a 510(k)?
- It depends on the device class. Class I is subject to general controls only, Class II to special controls, and Class III to premarket approval (PMA); a 510(k) notification is submitted for devices that are not exempt.
- When must a 510(k) be submitted?
- At least 90 days before the device is marketed.
- What if there is no similar device?
- The De Novo pathway is available for low- and moderate-risk devices with no existing equivalent. We research predicate devices and select the appropriate pathway together with you.
Sources: 21 CFR 860.3; 21 CFR 807.81; 21 CFR 807.87; FDA: Premarket Submissions.