FDA 510K Medical Device Requirements

New Medical Device Requirements FDA 510 k

Does Your New Medical Device Require a FDA 510k Petition and/or Clearance Approval?

The FDA is the governing body that regulates all new medical devices and products.  Manufacturers, distributors, resellers, and importers/exporters are all required by the FDA to register their new medical devices and products that are going to be sold in the United States. Most Class 1, some Class 2 , and all Class 3 medical devices/products will have to register there new device/product along with their respective business entity.

Does My New Medical Device Need an FDA 510k Pre-Market Notification Clearance?

- Medical device manufacturers, distributors, resellers, re-branders, and/or importers/exporters that want to market there new medical device or product to the US, and assuming there is evidence of an already approved, very similar, “predicate” device/product listed on the FDA website.

- If you are a development company that engineers new devices to be sold in the United States, but plan to have a different manufacturer produce the product for you.

- If your planning on using an existing FDA approved “Predicate” device or product in a different manner than which is was initially intended, or if your new device is a complete re-design of an existing Predicate product or medical device.

- Resellers, Re-packagers, Re-branders, and Distributors of new medical devices and products.

 New Medical Devices, Dental Devices, and Products That DO NOT Need an FDA 510k Approval

- Any medical device or product that can be classified as a Class 1 device/product that DOES NOT fall into the FDA’s Class 1 “reserved” status classification.

- Manufacturers, Resellers, Distributors, and Importers/exporters that deal with new medical devices and products that are unregulated by the FDA

FDA 510 K Consultants and FDA 510k Services

Contact Us Today for Assistance With Getting Your New Medical/Dental Device or Product FDA510k Clearance Status.