MDUFA III Guidance Documents

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

Documento	Issued
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
Guidance for Industry and FDA Staff and Foreign Governments; FY 2013 Medical Device User Fee Small Business Qualification and Certification	8/1/2012
Draft Guidance for Industry and FDA; Pre-Submission Interactions	7/13/2012
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; Interactions During Review of Medical Device Submissions	not yet issued
Guidance for Industry and FDA Staff; User Fees and Refunds for 510(k)s	not yet issued
Guidance for Industry and FDA Staff; User Fees and Refunds for Premarket Approval Applications	not yet issued