If you have come up with a great idea for a new medical device, or perhaps you already have the device ready to go, you’re going to need to know how to market it legally in the US. This involves making sure that your device is both safe and effective for human use. The Food and Drug Administration, otherwise known as the FDA, are responsible for ensuring that approved devices such as medical tools, instruments, drugs etc. are all 100% safe and effective for human or animal use. This involves preparing and submitting a 510(k) clearance.
What is 510(k)?
The 510(k) is a specific section of the Food, Drug and Cosmetic Act that states that all medical devices must be cleared and approved by the FDA before legal marketing is established. You must notify the FDA of your marketing intentions and submit your Premarket Notification (510(k)) either directly to the FDA or to an Accredited Persons.
Who is an “Accredited Persons”?
An Accredited Persons is a third party review program working on the behalf of the FDA to examine, analyse and review medical devices in a much faster and smaller time frame than the FDA themselves. This organization was created by the FDA with the intent to provide better quality services to people looking to have their devices cleared as soon as possible. Because of the large quantity of 510(k) submissions received each year, the wait for a final response can be extremely lengthy.
An Accredited Person such as fdathirdpartyreview, can shorten the time it takes for the FDA to give you a final response. After the initial review of your FDA 510k clearance submission, the program will forward the information on to the FDA, who are then required to give their final reviewing results within 30 days.
When Can I Market my Device?
Manufacturers can only market their device in the US market when their 510(k) submission has been approved with the FDA stamp of approval. A Premarket Notification is required in order to give your device the green light to allow for commercial distribution. The main purpose of your 510(k) submission is to prove that your device is safe and effective, in accordance to the FDA standards and those set by previously legally marketed devices. Your submission must include relevant and important details about your device including the design, energy source, chemical composition, material, intended use and the manufacturing process etc.