You are three easy steps away from submitting your 510k application!
First - Complete the registration process providing us with information on your device and send it to 510k Express. 510k Express reviews the information on your device.
Second – If 510k Express can complete a suitable 510k application we will let you know and provide an invoice for our services (remember for 510ks which can be submitted without a PMA, it is only $1995 USD). After receipt of your payment, 510k Express prepares the required forms and applications, even locating a suitable predicate device and gets this important application to you for your review, usually in three business days or less after receipt of your payment.
Third – When you are satisfied that the forms and application are complete and accurate (and there may be a need for additional information), you print the forms and applications, sign them and submit them to the FDA at the address we provide you.
The experts at 510k Express have successfully developed hundreds of regulatory applications on devices ranging from high volume disposables, cardiac implantables and In Vitro diagnostic test kits.
Receiving an USFDA 510k approval will open medical device regulatory doors right around the world!
