Medical Devices

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:

Document Issued
FY 2015 Medical Device User Fee Small Business Qualification and Certification - Guidance for Industry, Food and Drug Administration Staff and Foreign Governments 8/2/2013
Types of Communication During the Review of Medical Device Submissions - Draft Guidance for Industry and Food and Drug Administration Staff 3/5/2013
Guidance for Industry and Food and Drug Administration Staff - eCopy Program for Medical Device Submissions 12/31/2012
Guidance for Industry and Food and Drug Administration Staff - Acceptance and Filing Review for Premarket Approval Applications 12/31/2012
Guidance for Industry and Food and Drug Administration Staff - Refuse to Accept Policy for 510(k)s 12/31/2012
Guidance for Industry and FDA Staff; Actions on 510(k)s - Effect on Review Clock 10/15/2012
Guidance for Industry and FDA Staff; Actions on PMAs - Effect on Review Clock 10/15/2012
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 Classifications 3/28/2012
Guidance for Industry and FDA Staff; User Fees and Refunds for 510(k)s 4/2/2013
Guidance for Industry and FDA Staff; User Fees and Refunds for Premarket Approval Applications 4/2/2013

 

Page Last Updated: 09/30/2014
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