FDA 510k Consultants

When bringing a medical device to market in the United States, based on the risk class and intended use of the device to determine whether to (a) submit premarket notification, also known as 510(k), or (b) petition for premarket approval (PMA) exempted device.

While these three terms may sound similar, the amount of time, money, and documentation involved with each are completely different.

PMA: If your product is completely new to the United States market or classified as a Class III device, you'll be required to apply for PMA. Presently we are not supporting.

If the medical device you are planning to market in the USA is similar to one already on the market, the FDA 510(k) path is likely the way to go. It's the fastest and most economical way to get your medical device cleared.

When submitting an FDA 510k, you'll be required to illustrate both how your device is different from a nearest competitor's and that it maintains the same levels of safety and effectiveness as well as the same intended use.

While you will need to show documented laboratory testing, human data is typically not required for 510(k) submissions. However, if you're submitting an 510k for a device that has been significantly altered, you may be required to present results from clinical trials.

US FDA 510k consultants

All these complexities necessities the important of appointing a Consultant. We are FDA 510k Consultants provide complete solutions for 510k submissions and clearances.

FDA 510k is required for:

    a. Domestic manufacturers introducing a device to the U.S. market.

    b. Repacker or Relabeler who make labeling changes or whose operations significantly affect the device.

    c. Foreign manufacturers/exporters or U.S. representatives of foreign manufacturers /exporters introducing a Medical Device to the U.S. market.

510k is needed when:

    a. Anyone who wants to sell a device in the United States of America is required to make an FDA 510(k) submission at least 90 days prior to offering the device for sale, even though it may have been under development or clinical investigation before that date.

    b. Change in the intended use for a device which you already have in commercial distribution. ( Already cleared 510k)

    c. If there is a change or modification of a legally marketed device and that change could significantly affect its safety or effectiveness.

    d. A new 510(k) submission is required for changes or modifications to an existing device, where the modifications could significantly affect the safety or effectiveness of the device or the device is to be marketed for a new or different indication for use.

FDA 510k

Why FDA Consultants is strongly recommended

To ensure a successful US FDA 510k submission and 510k clearance, I 3 CONSULTING designed a strong technical and scientific method over the years by supporting with 510k clearance for worldwide customers by cost-effective and reduced probability of failure to receive 510k clearance. The process of 510k consulting detailed below.

  • Initial GAP assessment of the medical device in the scope of 510k
  • Product analysis
  • Predicate finding
  • Product classification
  • Identify FDA guidance for the specific product
  • The requirement of performance data study
  • Prepare a technical comparison of your medical device to the predicate device(s).
  • Product description writing
  • Label review and modification
  • FDA 510(k) document preparation (we develop, edit, review and compiled the 510k file. We will not allow the client to work on documentation)
  • Prepare all 21 sections of the FDA 510(k) application.
  • Coordinate for making payment of FDA 510(k) submission fees.
  • Submit the hard copy and eCopy to the CDRH division within the FDA
  • 510k follow-up with FDA officials and will correspondent for further communications with the FDA.
  • Responses to requests for additional information in the shortest time frame.
  • For foreign exporters, we act as US Agent for your firm.
  • US Agent / Consultant Immediately communicates with you regarding all information received from the FDA following the FDA submission and assist in addressing requests for additional information, if applicable.

More Information about Pre-Market Notification (510k) Click Here>>>

Frequently Asked Questions about USFDA submission and Clearance Click Here>>>

Please note that FDA does not perform fda 510(k) pre-clearance facility inspections. The submitter may market the device immediately after 510(k) clearance is granted. The manufacturer should implement FDA Quality System (GMP) as per 21 CFR 820 and ready to face inspection by FDA auditors at any time after 510(k) clearance. We are consultants for 21 CFR 820. More Details Click Here>>>

Our experienced US FDA 510k Consultants guide you in the right direction about requirements and submission process to get 510k clearance and 510(k) number for your medical device.

To know the fees/pricing for FDA 510k. Click Here>>>

If you need a quote, we recommend filling the QRF Online which helps us to understand the device in detail. You may also write to to get a quick reply.

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