FDA 510k Consultants for Guidance & Submission

We are FDA 510(k) Consultants provide Submission, Process & Guidance. Our experienced Consulting team guide you in the right direction about cost, requirements and clearances.

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 a 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 medical device, you'll be required to apply for Premarket Approval. 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 510k submission 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 510k submission process. However, if you're submitting a 510k for a device that has been significantly altered, you may be required to present results from clinical trials.

fda consultants

All these complexities necessities the important of appointing a FDA 510k Consultants or Agent.

510k Submission a must for

  1. Domestic manufacturers introducing a device to the U.S. market.
  2. Repacker or Relabeler who make labeling changes or whose operations significantly affect the device.
  3. Foreign manufacturers/exporters or U.S. representatives of foreign manufacturers /exporters introducing a medical device to the U.S. market.

510k Submission a must when

  1. Anyone who wants to sell a device in the United States of America is required to make an 510k submission at least 90 days before offering the device for sale, even though it may have been under development or clinical investigation before that date.
  2. Change in the intended use for a device which you already have in commercial distribution. (Already cleared 510k Process)
  3. If there is a change or modification of a legally marketed device and that change could significantly affect its safety or effectiveness.
  4. A new 510k 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.

510k submission process

Why FDA 510k Consultant is strongly recommended?

To ensure a successful US FDA 510 k guidance, submission or 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 submission are 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 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.

FDA will not perform any ONSITE inspection as part of FDA 510(k) clearance. Manufacturer can market the device soon after completing the registration and listing.

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 also provide consultation and technical guidance for 21 CFR 820.

Our experienced US FDA Consultants & Agents guide you in the right direction about 510k requirements, submission process to get clearance for your medical device.

  • How much will it cost to submit a 510k? Check our pricing  Click here

  • To know more about recently 510k cleared devices; Click here  Click here

Intrested to proceed? we recommend to fill the QRF Online which helps us to understand the device in detail. You may also write to us to get a quick reply.

We provide US FDA 510k Submission and Consulting services across the Globe. Our clients are from various cities of USA (United States) (New York, Los Angeles, Chicago, Houston, San Antonio, San Diego, Dallas, Boston and Miami), UK (United Kingdom) (London, Birmingham, Manchester, Liverpool, Newcastle, Sheffield) UAE (United Arab Emirates), Germany (Berlin, Hamburg, Munich, Cologne, Düsseldorf) India (New Delhi, Bangalore, Mumbai, Chennai, Pune, Ahmedabad)France, Netherland, Austrilla, Southafrica, Spain, Norway, Mexico, Canada, Malysia, Singapore, SouthKorea and Egypt

Client Testimonial....

I 3 Consulting Reviewed by Douglas Martine on . Consultants works efficiently and effectively during 510k preparation and FDA review period. I was really overwhelmed to see the weekly status report that motivates the internal team to work together. Rating: 4.9

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