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Related Experiment Videos

FDA recognition of consensus standards in the premarket notification program

D E Marlowe, P J Phillips

    Biomedical Instrumentation & Technology
    |June 10, 1998
    PubMed
    Summary

    The U.S. Food and Drug Administration (FDA) now accepts declarations of conformity to recognized standards for medical device approval. This streamlines the 510(k) process, saving resources and reducing market entry barriers for manufacturers.

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    Area of Science:

    • Regulatory Science
    • Medical Device Regulation
    • Standards Development

    Background:

    • The U.S. Food and Drug Administration (FDA) has historically promoted standards for medical device safety and effectiveness.
    • FDA reengineering efforts, driven by increased workload and reduced resources, highlighted the need for efficient regulatory processes.
    • The FDA Modernization Act of 1997 (FDAMA) mandates the use of standards in the medical device review process.

    Purpose of the Study:

    • To outline the FDA's strategic plans for integrating consensus standards into the medical device review process.
    • To detail the development of a standards recognition process for regulatory review.
    • To highlight the anticipated benefits of using standards for both the FDA and medical device manufacturers.

    Main Methods:

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    • The FDA will recognize select consensus standards for use in the device approval process.
    • Under the new 510(k) paradigm, manufacturers can submit declarations of conformity to standards as evidence of safety and effectiveness.
    • The International Electrotechnical Commission (IEC) 60601 series was the first set of standards chosen for regulatory review.

    Main Results:

    • Manufacturers can now submit declarations of conformity to recognized standards, bypassing traditional review processes.
    • The FDA has published a list of recognized standards in the Federal Register.
    • Other standards from recognized organizations like AAMI may also be eligible for use in regulatory review.

    Conclusions:

    • The adoption of standards in the device review process is expected to save the FDA considerable resources.
    • This initiative aims to reduce regulatory obstacles, facilitating market entry for domestic and international manufacturers.
    • Reliance on declarations of conformity to recognized standards enhances efficiency and promotes medical device safety and effectiveness.