Scribd Logo
Hochladen

Willkommen bei Scribd!

  • 510 (K) Flowchart

    Hochgeladen von

    Larryag12196
    69 Ansichten1 Seite
    The document discusses the 510(k) pathway for medical devices to gain market entry in the US. The 510(k) process requires identifying a similar "predicate device" that has already received FDA authorization. If a predicate exists, a 510(k) application can be prepared within 45 days with the required documents to show the new device is substantially equivalent. The FDA then has 80 days to respond by requesting additional information or providing marketing authorization. Once approved, manufacturers must register with the FDA but are subject to inspection for quality standards.

    Originalbeschreibung:

    Originaltitel

    510(k) Flowchart

    Copyright

    © Attribution Non-Commercial (BY-NC)

    Verfügbare Formate

    PDF, TXT oder online auf Scribd lesen

    Stufen Sie dieses Dokument als nützlich ein?

    Sind diese Inhalte unangemessen?

    Dieses Dokument melden
    The document discusses the 510(k) pathway for medical devices to gain market entry in the US. The 510(k) process requires identifying a similar "predicate device" that has already received FDA authorization. If a predicate exists, a 510(k) application can be prepared within 45 days with the required documents to show the new device is substantially equivalent. The FDA then has 80 days to respond by requesting additional information or providing marketing authorization. Once approved, manufacturers must register with the FDA but are subject to inspection for quality standards.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Als PDF, TXT herunterladen oder online auf Scribd lesen
    Markieren Sie unangemessene Inhalte
    69 Ansichten1 Seite

    510 (K) Flowchart

    Hochgeladen von

    Larryag12196
    The document discusses the 510(k) pathway for medical devices to gain market entry in the US. The 510(k) process requires identifying a similar "predicate device" that has already received FDA authorization. If a predicate exists, a 510(k) application can be prepared within 45 days with the required documents to show the new device is substantially equivalent. The FDA then has 80 days to respond by requesting additional information or providing marketing authorization. Once approved, manufacturers must register with the FDA but are subject to inspection for quality standards.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Als PDF, TXT herunterladen oder online auf Scribd lesen
    Markieren Sie unangemessene Inhalte
    von 1

    510(k) PATHWAY TO MARKET ENTRY

    The majority of medical devices that enter the US market require the submission of a
    FDA application known as a 510(k). A 510(k) is needed for a few Class 1 devices, for
    nearly all Class 2 devices and can be used for a very small amount of Class 3 devices.
    The following diagram will help you understand the 510(k) application process

    PREDICATE DEVICE
    You need to identify if another device that is very similar to
    yours has already received FDA authorization for market. If
    this has happened, it can be used to support your application
    as a predicate device

    YES
    NO
    A 510(K) application can be
    Your device is entirely
    prepared and submitted in
    different from any others
    approximately 45 days as
    authorized by the FDA and
    long as all required
    may be new technology
    documents are available

    Devices that are of a common family You may need to conduct clinical trials
    can frequently be submitted in a single and apply for an IDE or PMA. This will
    510(k) require more time and can be costly.

    The FDA has 80 days to respond after


    submission. They will then either ask CSI can assist you in deciding which
    questions or will present you with a pathway you will need to follow. We are
    letter of authorization. experienced in both applications

    CONGRATULATIONS!
    If your submission is approved, your Once the forms have been filed,
    company will need to file 2891 & 2892 you are approved to sell your
    forms online to register your company product in the United States.
    and device
    Your company is now subject to FDA
    inspection for GMP standards at ANY
    TIME no matter where your company is
    located.

    Das könnte Ihnen auch gefallen