As per US FDA Medical Device requirment, all medical device manufactures must register facility and list there device prior to market in the USA. Listing of medical devices possible only after 510k clereance or PMA clereance or the device must be exempted from 510k.
A 510(k) clearance can be obtained from USFDA after submitting a technical dossier and following the successful review. A 510(k) contains detailed technical, safety, and performance information about a medical device and must demonstrate the device in question is "substantially equivalent" to a predicate device (i.e. a product already cleared and sold in the US).
FDA 510(k) submissions and clearance are required for most Class II (as well as some Class I and Class III) medical devices and IVDs.
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.
Following clearance of your device, you must list your product with the FDA. If this is your first time selling to the US market, you will need to register your company as well. You must also pay the annual establishment registration fee to maintain your company registration.
Successful FDA 510(k) Submission is possible only with the help of experienced technical and scientific consultants like EUROPECERT who specialized in this subject for more than 14 years. Missing information and deficiencies in your 510(k) submission can lead to failure and may delay your product launch by months or years. EuropeCert Consultants provide one to one preliminary guidance for your FDA 510k submission, helping you shorten your clearance process. We have our own accredited testing laboratories for product testing, Documentation team and inhouse US Agent. Our lead consultants and auditors have extensive experience with FDA 510k submissions.
New Medical Devices Regulation is released by European commision
It is important that you prepare the Medical Device Technical File to meet the new requirements by end of 2019, so you are ready for MDR certification soon after your Notified Body is identified.
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