What Are the FDA Requirements for 510(K) Submissions for Medical Devices?
Most manufacturers of medical devices must submit a 510(K) premarket notification or a premarket application (PMA) before commercializing in the United States. What is a 510(K) or a PMA? Who is required to submit a 510(k) or a PMA? When are they required?
Defining 510(K) for Medical Devices
The United States Food and Drug Administration (FDA) determines the rules on medical device regulatory submissions and compliance. Devices that fall under premarket notification requirements are Class II, and Class III devices require PMAs. Without completing the required testing and documentation of the testing, device manufacturers will not be able to legally sell their products in the United States.
The purpose of the 510(K) submission and approval is to attest to the fact that the product in question is not harmful. It also provides official testimony that the device can do what the manufacturer claims it can accomplish. Submitting 510(K) documents to the FDA is a declaration that the new medical device is substantially equivalent to an existing product previously cleared. This means that the device is similar enough in design, purpose, and use of an existing product that it can be considered safe by default.
Manufacturers meet with FDA in a pre-submission meeting to mutually agree upon the regulatory strategy. Once this is agreed upon, and a clinical trial is not required, the medical device manufacturer, once all requirements are met, may submit the 510(k) premarket notification to FDA. Once cleared, the device may be marketed for commercial use.
There are 3 categories of 510(K) notifications:
- Traditional 510(k) premarket notifications are used for new devices. These manufacturers must complete all verification steps to achieve market clearance.
- Special 510(k) premarket notifications are reserved for devices that do not need conformance data.
- Abbreviated 510(k) premarket notifications manufacturers are able to provide summary reports on the use of guidance documents and/or special controls, or declarations of conformity to recognized standards, to expedite the review of a submission.
What Are the Requirements for 510(K) Submissions?
There are four criteria that qualify a medical device for 510(K) premarket notifications.
- For domestic manufacturers who plan to market their goods in the United States, medical compliance, as your regulatory affairs consultant will explain, requires proof of the safety and efficacy of finished products. This does not apply to manufacturers of components used in the construction of finished products.
- Specification developers outline the product’s final form but outsource the actual construction to another party. In this case, the specification developer is responsible for the premarket notification.
- Repackagers who make significant changes to package instructions or information may be required to submit paperwork.
- Foreign manufacturers or exporters who wish to market their goods in the United States often need to submit proof of efficacy and safety before putting their products up for sale.
When Is a 510(K) Required?
510(k) premarket notifications are required for all new Class II products unless they are exempt. The FDA guidelines require 510(K) submissions when a new device is being introduced for commercial distribution. Paperwork must be submitted at least 90 days before commercialization and the device manufacturer must receive a 510(k) clearance letter.
Existing devices that are modified in a way that could affect efficacy and safety may also be required to submit documents. In these cases, the FDA lets the marketer decide if paperwork is necessary. However, all modifications must follow current Quality System Regulations. This also applies when an existing device is to be marketed for use beyond its originally stated purpose.
Premarket notifications are not required for products made for testing purposes, when unfinished devices are sold to another party for further processing, if the product was already in distribution before May 28, 1976, or other exempt parties.
Is a 510(K) premarket notification in your future? Rely on the expertise of CUBE Medical Innovations and our regulatory affairs consultants and partners at Eminence Clinical Research to guide you through the process. We can help you design, build, test, and manufacture your commercial 510(K) medical device. We also walk you through the maze of regulatory affairs and requirements to get your device approved and ready for purchase. Contact our device development experts to learn how CUBE Medical Innovations can make your 510(K) submission process easier.
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