510k database how to#
510k database registration#

You must also pay the annual establishment registration fee to maintain your company registration. If this is your first time selling to the US market, you will need to register your company as well. This letter will note that your device is substantially equivalent to the predicate device outlined in your application.įollowing clearance of your device, you must list your product with the FDA. Upon successful review of your 510(k) application, the FDA will send a 510(k) clearance letter with your device’s unique 510(k) number, and a copy of the device’s cleared Indications for Use. The 510(k) program, which clears about 3,800 to 4,000 products a year, is critical to a vibrant and successful device industry, according to testimony for the hearing from David Nexon, senior executive vice president for the Advanced Medical Technology Association, a trade group FG FDA 510(k) cleared The QualityStocks Blog keeps investors up to date on everything. What to do when the FDA clears your medical device Responses to RTA and AI requests must be submitted within calendar 180 days. The 90-day review clock stops if the FDA issues a Refuse-to-Accept (RTA) or Additional Information (AI) letter, which indicate the FDA needs more information or documentation to complete their review. The FDA timeframe for 510(k) review is calendar 90 days. Most 510(k)s are well over 100 pages, and must meet the FDA’s eCopy (electronic document) submission requirements to be accepted for review. All relevant protocols, test reports, and other documentation are provided as attachments or exhibits. The common structure utilizes 20 individual sections to address each 510(k) requirement.

510k database how to#

Preparing a 510(k) can be challenging and the FDA is fairly strict about how to organize the submission. How to prepare an FDA 510(k) for medical devices If you cannot determine the classification for your product, you can submit a 513(g), which is a written request to the FDA seeking classification confirmation. The FDA must review the 510(k) and 'clear' your device before you can legally sell or distribute it in the United States.ĥ10(k) submissions are required for most Class II (as well as some Class I and Class III) medical devices and IVDs. a product already cleared for sale in the US). The documentation must demonstrate the device in question is 'substantially equivalent' to a predicate device (i.e. A 510(k) contains detailed technical, safety, and performance information about a medical device. Dear Reader: Every year Emergo examines published data on medical devices cleared by the US Food and Drug Administration (FDA). It is formally called a Pre-market Notification. A 510(k) is the technical dossier required by the US Food and Drug Administration (FDA) to sell a medium-risk medical device or IVD in the United States.