FDA 510(K) Medical Device Clearance in a nutshell

The U.S. Food and Drug Administration (FDA) has issued recently the Final Guidance on the 510(k) Third Party Review Program and updated the list of medical devices eligible for review. This is part of the continuous efforts that FDA put in its actions for the benefit and safety of the patient while the routine and duplicative re-reviews of certain information by the staff are eliminated.

What is a 510(k)

510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, substantially equivalent to a legally marketed device that is not subject to premarket approval. The name comes from the section 510(k) of the Federal Food, Drug and Cosmetic Act (FDCA).

Essentially, each organization that wants to market in the U.S.A. medical devices intended for human use, for which a Premarket Approval Application (PMA) is not required, must submit a 510(k) to FDA demonstrating that the device is safe and effective. This is one of the major pathways for bringing medical devices to market.

Who is required to submit a 510(k)

There are four categories of parties that must submit a 510(k) to the FDA:

  1. Domestic manufacturers introducing a device to the U.S. market
  2. Specification developers introducing a device to the U.S. market
  3. Repackers or relabelers who make labeling changes or whose operations significantly affect the device
  4. Foreign manufacturers/exporters or U.S. representatives of foreign manufacturers/exporters introducing a device to the U.S. market

What is Third Part Review Program

The Center for Devices and Radiological Health (CDRH) has implemented a program that provides manufacturer of certain devices the possibility to submit their 510(k) to Recognized Third Parties identified by FDA for review, instead of submitting directly to CDRH. The participation of the submitters in this program is completely voluntary.


Which devices are eligible for 510(k)

The full list of medical devices eligible for 510(k) Premarket Notification is published and maintained updated by the FDA, and contains the classification regulation number for each device (generic type of device), the name of the device and its class, device-specific guidance or general guidance to assist manufacturers in the preparation of the documentation.

Here are the main categories based on the device’s purpose:

AnesthesiologyCardiovascularClinical ChemistryDental
Ear Nose & ThroatGastroenterologyGeneral & Plastic SurgeryGeneral Hospital
Obstetrics & GynecologyOphthalmicOrthopedicPathology
Physical MedicineRadiologyToxicologyMolecular Genetics

How Intesi Group can help you

The 510(k) can be submitted through the FDA Electronic Submissions Gateway (ESG), the Agency-wide solution for accepting electronic regulatory submissions.

Intesi Group digital certificates were declared compliant by the FDA, allowing your company to speed up the process of bringing a medical device on the market.

Intesi Group has a wide-range digital solutions dedicated to pharmaceutical and health care ecosystem, allowing companies to speed up the going-to-market process, reducing considerably the cost and staying compliant with global regulatory requirements at the same time.

If you want to know more about, engage with our specialists for Life Sciences and Health Care by sending an email at lifesciences@intesigroup.com