To market a medical device in the USA, it is mandatory to submit a premarket notification (510(k) submission) to the US FDA to confirm the device’s safety and efficacy on par with the predicate device. A 510(k) submission is majorly required for Class II devices, and few Class I and Class III devices. It is required for domestic manufacturers, foreign manufacturers / exporters or US representatives of foreign manufacturers / exporters and specification developers while introducing a device into the US market. Repackers or relabelers who make labeling changes or whose operations significantly affect the device must also submit a premarket notification, i.e. (510(k) submission).

Aiming at streamlining the 510(k) submission processes, two additional and optional approaches have been added to the Traditional 510(k). They are:

  • Special 510(k) - Manufacturers can submit a Special 510(k) application when a 510(k)-cleared device has been modified after the notification, if the modification does not affect the intended use or does not alter the fundamental scientific technology of the device.
  • Abbreviated 510(k) - Manufacturer can submit an Abbreviated 510(k) application when device guidance documents are available, and a special control is established for the device.

Apart from the two traditional approaches, FDA has recently launched the ‘Quality in 510(k) Review Program Pilot’ (“Quik”). It is an alternative method for preparing a 510(k) application through FDA’s eSubmitter software which is piloted for a selected list of device types, mainly for moderate risk devices.

To assist manufacturers with compliant 510(k) submissions, Freyr provides support in compiling the device information for the submission via e-submission platform along with needed assistance in examining substantial equivalence to predicate device.

Freyr Expertise

  • 510(k) compilation
  • 510(k) eSubmission
  • Examination of the substantial equivalent device
  • Device listing & FURLS database maintenance
  • Comprehensive USFDA Regulatory strategy

Freyr Advantage

  • Expert team for 510 (k) compilation
  • Additional support to handle 510(k) queries
  • Advice for the suitable type of 510(k) as per device requirement
  • On-time submission of deliverables
  • Up to date with USFDA new amendments