Document Application For Medical Device Manufacturers Online For Free

Medical Device Technical File Contents Description of the device and specification: In this section, you will include the product or trade name, along with a general description of the medical device. ... Labeling and usage instructions: This section will contain the device labels and their packaging details.

The process of getting a 510k clearance requires finding an equivalent product (predicate device) to a new product to prove its substantial equivalence. Once the device is proven equivalent to an already approved equivalent it can be legally marketed as per US FDA guidelines.

Annual Establishment Registration Fee: $7,653 Application TypeStandard FeeSmall Business Fee?510(k)?$21,760$5,440513(g)$6,528$3,264PMA, PDP, PMR, BLA$483,560$120,890De Novo Classification Request$145,068$36,2676 more rows ? 29-Sept-2023

Your 510(k) submission should: Demonstrate your medical device is 'substantially equivalent' to a predicate already on the market. House detailed technical, safety and performance device/test information to show your device is safe and effective. Prove you have a robust medical device quality and risk management system.

The average time for 510(k) clearance in 2021? 175 DAYS. It is worth noting that the most common time window to clearance (median) is 80-90 days, followed very closely by 50-60 days.

The most common types of premarket submissions include: 510(k) (Premarket Notification) PMA (Premarket Approval) De Novo Classification Request.

Who is Required to Submit a 510(k) The FD&C Act and the 510(k) regulation (21 CFR 807) do not specify who must submit a 510(k). Instead, they specify which actions, such as introducing a device to the U.S. market, require a 510(k) submission.