FDA 510(k) Submission and Approval

FDA 510-K is a part of the US Federal Food, Drug and Cosmetic Act. Section 510(k) of the Food, Drug and Cosmetic Act requires medical device manufacturers who must register, to notify FDA of their intention to market a medical device at least 90 days in advance. A FDA 510k is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to device which is already in market. During the FDA approval process, the medical device’s safety, risks, benefits and other information are looked upon. A successful 510k submission results in FDA permission to market the new device in United States.

The 510K approval process is similar to the approval process for any other medical device. After the filing of Premarket Notification (PMN) or 510K, the manufacturer is required to wait for at least 90 days before taking any further actions to market the device. During this 90 days period, the FDA examines the PMN and checks for the various parameters of the device. If the device conforms to all preset rules and regulations, FDA gives permission to sell the product, which is known as 510(k) clearance.

Most Class 2 (and some Class 1 and Class 3) medical devices are subject to FDA’s Premarket Notification (PMN) or 510(k) submission process. This whole concept is based upon substantial equivalence and is unique to the US medical device regulations. So, the objective is to show that your device is substantially equivalent to some other devices already on the US market. Technically, the FDA does not “approve” medical devices; they “clear” them for sale. Also, the 510k clearance letter may also be used as a marketing tool for countries other than the US.

MedDeviceCorp is the ONLY consulting company who takes up complete turnkey FDA 510(k) projects. We takeup any type of medical devices anywhere from the world.

Special features of MedDeviceCorp
  • We will not assist, we prepare 510k!!!.
  • We provide service of US Agent!!!.
  • Initial in-depth study of product and regulatory followed by overall guidance.
  • Development of a Project Plan and confirmation of the specific deliverables.
  • Guidance on testing.
  • Communicate to FDA regarding review comments.
  • Support in implementing 21 CFR 820.
  • Establishment registration.
  • Listing of products with US FDA.
  • Payment after completing every phase.

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