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U.S. Department of Health and Human Services

Medical Devices

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MDUFA III Guidance Documents

The FDA is issuing a series of guidance documents that help explain key provisions of MDUFA III. These guidance documents include:

DocumentIssued
Guidance for Industry and FDA Staff and Foreign Governments; FY 2014 Medical Device User Fee Small Business Qualification and Certification8/2/2013
Types of Communication During the Review of Medical Device Submissions - Draft Guidance for Industry and Food and Drug Administration Staff3/5/2013
Guidance for Industry and Food and Drug Administration Staff - eCopy Program for Medical Device Submissions12/31/2012
Guidance for Industry and Food and Drug Administration Staff - Acceptance and Filing Review for Premarket Approval Applications12/31/2012
Guidance for Industry and Food and Drug Administration Staff - Refuse to Accept Policy for 510(k)s12/31/2012
Guidance for Industry and FDA Staff; Actions on 510(k)s - Effect on Review Clock10/15/2012
Guidance for Industry and FDA Staff; Actions on PMAs - Effect on Review Clock10/15/2012
Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff 2/18/2014
Guidance for Industry and FDA Staff; Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications3/28/2012
Guidance for Industry and FDA Staff; User Fees and Refunds for 510(k)s4/2/2013
Guidance for Industry and FDA Staff; User Fees and Refunds for Premarket Approval Applications4/2/2013