Definition
Premarket notification forms and documentation submitted by medical device companies to the United States FDA is searchable in the FDA 510(k) database.
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 a class III medical device.
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.
FREE DOWNLOAD: Click here to download a PDF of our 510(k) submission checklist.
What is an FDA 510(k) submission?
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 devices - and that it is therefore safe to be allowed into the marketplace.
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.
How to access the FDA 510(k) Database
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.
What information is searchable in the FDA 510(k) database?
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:
- The device classification name
- 510(k) number
- The name of the device
- The name of the applicant which filed the 510(k)
- Contact information for the applicant
- An assigned classification product code that indicates the type of medical device
- The date that the 510(k) notification was received and the date that a decision was made
- The substantial equivalence decision result (whether the 510(k) notification successfully demonstrated substantial equivalence between the new medical device and a predicate device)
- Any specific FDA regulations that apply to that medical device
- Identification of the 510(k) review panel that reviewed the notification for the device
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 helps streamline the 510(k) submission process
When it comes to obtaining 510(k) clearance, Greenlight Guru helps medical device manufacturers avoid some of the most common 510(k) pitfalls and mistakes that can stall or delay the process.
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.
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