Process of FDA 510k Submission

  • Appoint an experienced Consulting company:

    The consultant or the consulting team should have through knowledge and previous experiences in Medical Device submissions to FDA. The consultants should take responsibility of your submissions and communications with FDA on behalf of customer till receipt of K number. Read More >>

  • Determine your product (a) is a medical Device or (b) radiation emitting product:

    Once it is identified, proceed with compiling the FDA regulatory requirements required for marketing the product in US.

  • Classify the medical Device:

    This will help us to make sure 510k route can be used to market along with device code submission procedure and other applicable compliance issues.Read More >>

  • Implement 21 CFR 820 if Applicable:

    If the product is not exempted from GMP, you need to implement GMP in the manufacturing location. This is not a requirement at for 510k submission, but all firms registered should be prepared to face Inspection, if failed FDA will issue warning letter to the manufacturer and you will be forced to withdraw products from the market. Read More >>

  • Test the product/Equipment:

    For preparing FDA notification test reports and data sheets is very much essential. The applicable standards have to be identified and testing to be done from accredited laboratories.

  • Review the Test report:

    Review of test reports to be carried out based on the standards and acceptance criteria. Any errors in the report cannot be used in 510k notification.

  • Appoint US Agent:

    Appoint an US Agent for assisting FDA in communications with the foreign establishment, answering to questions concerning the foreign establishment's devices that are to be imported into the United States. Read More >>

  • Prepare 510k Notification and Submit:

    Prepare 510k notification with the help of a consultant, and submit to FDA directly or through UL / Interk / BSI with the help of Consultant / US Agent.

  • Register the establishment:

    Manufacturer has to register the establishment involved in the production and distribution of medical devices intended for use in the United States are required to register annually with the FDA under section 510(g) of the act. Read More >>

    An owner or operator of an establishment located in any of the State in US as defined in section 201(a)(1) of the act shall register its name, places of business and list the devices if interstate trading is done.

  • List the device with FDA:

    Once the establishment registration is done, the products intended to sell in US has to list under registered establishments. If a device requires premarket approval or notification before being marketed in the U.S., then the owner/operator should also submit the FDA premarket submission number. Read More >>

    Readers can contact us for more clarification.

    Role of the consultant

    Applicable cost

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