If you are planning to manufacture or distribute a medical device within the United States of America, the FDA requires (in most cases) that you complete either a 510k submission or obtain premarket approval for your medical device. Whether your device requires premarket approval, and what kind of approval it needs, depends on the device classification, which corresponds to device risk. As such, medical device manufacturers must complete the following steps from the outset of the product development process:
The FDA divides medical devices into three classes that correspond generally to their risk profile:
Class I: These devices are simple, with minimal risk to the user. They are subject to the general regulatory controls of medical devices and typically do not require any premarket submissions.
Class II: Devices in this class pose a moderate level of risk to the user, and all of them require a premarket notification (510k submission) before they can be legally marketed. Items like pregnancy testing kits, intravenous kits, sutures, and powered wheelchairs could fall into this category. These devices are important for health care, but a malfunction would be unlikely to cause critical harm to a patient.
Class III: Class three devices are typically either implanted medical devices or those that sustain life, like an implantable pacemaker, blood vessel stents, or other implanted device. Devices in this class are seen as the highest risk for patients, as any problems with the device could lead to significant adverse outcomes for the patients. Class III devices require a PMA submission before being marketed in the USA.
So far, we've learned that Class II medical devices require a 510k submission (premarket notification), while Class III devices require a PMA (premarket approval), but what is the difference between these two processes?
The purpose of a 510k submission is to provide the FDA with documented evidence which proves that your medical device is substantially equivalent to a predicate device, one that has already been approved for marketing by the FDA. The FDA processes 510k submissions in 30-90 days and if your application is accepted, your submission will be posted to the FDA 510(k) database. Proving substantial equivalency means that you'll need to compare and contrast your device with the predicate device, and while laboratory testing is a typical requirement, human testing is usually not needed for 510k submissions. Information from your documented Design Controls process, such as intended use, indications for use, design inputs (learn how to define them here), and design verification are all
A PMA is more in-depth than a 510k - it is used to prove that a new device is safe and effective for the end user and typically requires clinical trials with human participants along with laboratory testing. The standards here are much higher than for 510k submissions, and the FDA has just 180 days to accept or reject the application.
Whether you are building a new and revolutionary high-risk device that requires a PMA, or you're sourcing information from your design controls to prove substantial equivalency to another product as part of a 510k submission, greenlight QMS securely organizes all of the required information, making it simple to create and revise your regulatory submissions as you develop your product.
An organized and secure single source of truth for your medical device company is instrumental in expediting compliance with FDA regulations and getting your product to market as quickly as possible.