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    FDA Device Info: PMA Historical Guidance Documents

    FDA Device Info: PMA Historical Guidance Documents

    $49.00 USD
    $49.00 USD
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    Contents: Historical guidance documents.

    1. 1998, entitled "Modifications To Devices Subject to Premarket Approval €“ The PMA Supplement Decision Making Process"
    2. 1986, entitled "Premarket Notification Review Program," 510(k) Memorandum K86-3, dated June 30, 1986
    • Status: Pending Fast-Track Request
    • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

    NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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