A medical device has to mandatorily make a submission for premarket approval (PMA) to the FDA to demonstrate that the device to be marketed is substantially equivalent or at least as safe and effective as a non PMA-subjected legally marketed device. This submission is called 510 (K).
A medical device company has to submit a product for PMA when it manufactures or makes changes and modifications that could substantially affect safety and effectiveness requirements under 21 CFR 807 and design control requirements under the Quality System (QS) regulation. FDA provides guidance on how to meet the QS regulation requirements, under which all Class II and III devices and certain Class I devices have to be designed in conformance to 21 CFR 820.30 Design Controls.
Step-by-step process for designing a bullet proof 510 (K)
Medical device companies which submit their premarket notification to the FDA for approval signal their intent to market their device. This submission has to be done at least 90 days before they register the product. Some logical and commonsensical steps have to be followed in designing a bullet proof 510 (K), meaning that the PMA is strong and not capable of being rejected by the FDA. Medical device manufacturers can follow these structured steps for designing a bullet proof 510 (K):
- Ensure, using the FDA classification database, that the product to be submitted for PMA is a medical device. This database is quite exhaustive, and has clear definitions and descriptions of the criteria that medical products have to meet if they have to be considered as medical devices
- In order to create a bullet proof 510 (K); the company has to also search and identify if similar products have already been approved by the FDA or others have filed for PMA for such a product with the FDA
- The medical device company has to next get a grasp of the guidances and standards that apply to the product that they are submitting for 510 (K). The FDA’s Product Classification Code is a good guide for this
- Get down to doing the submission work and send the completed 510 (K) form to the FDA
- Wait for the 90-day period that the FDA will take to review each submission
- Once the device has been cleared for submission by the FDA; the company has to start the registration process by paying the requisite fees after getting the unique 510 (K) number
- Appointing a US Agent, if the medical device manufacturer is from a country other than the US, is another important step for bullet proof 510 (K). The US agent takes care of the administrative work with the FDA.