US fda 510k Zulassung Beratung

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.

Frequently Asked Questions

How to prepare an FDA 510(k) for medical devices

Preparing a 510(k) can be challenging and so difficult as FDA is much strict on file arrangements and submission method. Individual sections to address each 510(k) requirement. All relevant protocols, test reports, and other documentation are provided as attachments in an orderly fashion. The number of pages may vary depending on the type of device and how elaborate you prepared the documents, but mostly it may contain 400 to 500 pages, and must meet the FDA’s eCopy (electronic document) submission requirements to be accepted for review.
FDA review times for 510(k) submissions

The FDA timeframe for 510(k) review is calendar 90 days. The 90-day review clock stops if the FDA issues a Refuse-to-Accept (RTA) or Additional Information (AI) letter, which indicate the FDA needs more information or documentation to complete their review. Responses to RTA and AI requests must be submitted within the timeline provided in the letter.
Do we have a situation FDA NOT clears your medical device

Yes, the clearance percentage is 67 to 70 percentage based on our study.
Medical Device Testing Requirements for 510(k) Submissions

Are you preparing a 510(k) submission to the FDA, it is important to find the right testing requirements and test laboratory. It is a challenge. And, failure to do so could result in a longer 510(k) review time if the FDA sends an Additional Information (AI) Request. If you cannot provide the requested test data in a timely manner, you might even have to withdraw your 510(k) submission.
What is the procedure to be followed after 510k clearance?
Upon successful review of your 510(k) application, the FDA will send a 510(k) clearance letter with your device’s unique 510(k) number, and a copy of the device’s cleared Indications for Use. This letter will note that your device is substantially equivalent to the predicate device outlined in your application followed by you can…
- Step 01 - Register the facility
- Step 02 – List the device
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US FDA 510k

New Medical Devices Regulation is released by European commision

Frequently Asked Questions