Medical device companies who wish to sell their products in the United States must obtain approval from the FDA through one of several regulatory avenues. For some devices, this means participating in the Premarket Approval (PMA) process, a scientific review conducted by the FDA to determine the safety and effectiveness of
Medical device manufacturers that are introducing a new product to the market, or have substantially modified an existing device in order to create a new one must complete a 510(k) premarket submission to the FDA. The FDA maintains a database of premarket notification 510(k) submissions on its official website, enabling users to search for existing submissions using criteria such as the 510(k) number, applicant, device name or FDA product code.
The 510(k) submission process provides an additional avenue for medical device companies to obtain approval for marketing their devices in the United States. Rather than going through the lengthy scientific review associated with the premarket approval process, medical device manufacturers can undertake a 510(k) submission to demonstrate that their product is substantially equivalent to other legally marketed
A medical device company that wishes to market a class I, class II or class III medical device in the United States, and for which a premarket approval (PMA) is not required, must submit a 510(k) premarket notification to FDA unless the device qualifies for an exemption from the requirements of the Federal Food, Drug and Cosmetic Act.
The FDA’s database of 510(k) premarket notifications is available for public access on the department’s official website. Users can search through the FDA’s historical database of 510(k) notification documents, including applications for some of the most recent innovations in medical device technology by the world’s largest medical technology companies.
Users can search the FDA 510(k) database by entering the name of a specific medical device, the name of the applicant who filed the 510(k) premarket notification paperwork for the device, or by entering the specific 510(k) number or product code associated with a given device. The database is updated weekly with newly reviewed 510(k) notifications.
To access a broad sampling of 510(k) notifications, users can use broad search terms like “pump” or “heart”. The database search tool also allows users to search for categories of medical devices based on the FDA panel that evaluated them. For medical device developers, this offers an easy way to gain insight into what new innovations may become popular in your field of expertise. Simply highlight the dropdown menu labeled “Panel” and choose to see search results for medical devices used in Toxicology, Gastroenterology, Cardiology, or another specialization of your choice.
When a user clicks on an individual search result in the FDA 510(k) database, they will be presented with additional information pertaining to the 510(k) notification paperwork that was filed for the device. These include:
In addition to these data points, the FDA may provide a link to the original 510(k) notification documents that were submitted. These documents are useful as a template for what a successful 510(k) application might look like when coupled with a safe and effective medical device
Greenlight Guru's eQMS software helps medical device companies ensure quality throughout the product design and development process. Designed exclusively for the medical device industry, the cloud-based platform becomes the single source of truth for the secure storage and management of all documentation related to a manufacturer’s 510(k) submission.