To apply for a Free to Sell Certificate for a medical device in the United States, manufacturers typically need to follow these steps:
Determine the medical device classification: First, manufacturers need to determine which FDA class their medical device falls into. The FDA classifies medical devices into three categories based on their risk level: Class I, Class II, and Class III. Different categories of devices need to follow different approval processes.
Get 510(k) advance market notice or PMA approval:
510(k) AMC: If the medical device is classified as a Class I or Class II, manufacturers are typically required to file a 510(k) AMC. This involves submitting a request to the FDA that includes information such as device description, performance data, clinical trial data, etc. FDA will review the application and approve a 510(k) notice if it determines that the device is equivalent to a comparable device already on the market and meets safety and efficacy requirements.
PMA Approval: For Class III medical devices or for certain high-risk medical devices, manufacturers are required to submit a PMA application. This requires manufacturers to provide more clinical trial data and other evidence to demonstrate the safety and efficacy of the device. The FDA conducts a more rigorous review of PMA applications.
Submit an application: Once a manufacturer has the required documents and information ready, they can submit an application to FDA through FDA's electronic filing system, such as the FDA e-filing portal.
Review Process: The FDA will review the submitted application. During the review process, FDA may request further information or conduct additional testing. Manufacturers need to cooperate with the FDA to provide the required information.
Approval and Certificate Issuance: If the FDA determines that a medical device meets safety and efficacy requirements, they approve a 510(k) advance market notification or PMA application. Once approved, the FDA issues a Freedom to Sell Certificate to the manufacturer, allowing them to freely sell the medical device in the U.S. market.