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U.S. Department of Health and Human Services

Medical Devices

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CDRH Freedom of Information (FOI) Reference Sheet

This table describes the types of information that are releasable through the Freedom of Information (FOI) process from FDA
ELEMENTSPREMARKET APPROVAL (PMA) Documents 21 CFR 814.9INVESTIGATIONAL DEVICE EVALUATION (IDE) Documents 21 CFR 812.38PREMARKET NOTIFICATION (PMN/510k) 21 CFR 807.95
AppealsOnly releasable through the FOI Staff.Only releasable through the FOI Staff.Only releasable through the FOI Staff.
Approval LettersContained in the Summary of Safety and Effectiveness (SS&E) and released by Dockets Management (with a Docket Number); approvals after September 1996 are available on the Internet.Not ReleasableOnly releasable through the FOI Staff.
Approvable LettersNot ReleasableN/AN/A
Bench/Clinical DataNot ReleasableNot ReleasableNot Releasable
Consent FormsOnly releasable through the FOI Staff.Only releasable through the FOI Staff.Only releasable through the FOI Staff.
Certifications of DocumentsOnly releasable through the FOI Staff.Only releasable through the FOI Staff.Only releasable through the FOI Staff.
DenialsOnly through the FOI Staff and coordinated through General CounselOnly through the FOI Staff and coordinated through General CounselOnly through the FOI Staff and coordinated through General Counsel
LabelingContained in SS&E and released by Dockets Management (with a Docket Number); approvals after September 1996 are available on the Internet..N/A or Not ReleasableOnly releasable through the FOI Staff after Predisclosure Notification
Manufacturer's Standard Operating Procedures (SOP), In-house Quality Assurance ProceduresNot ReleasableNot ReleasableNot Releasable
Minor DeletionsOnly releasable through the FOI Staff.N/AOnly releasable through the FOI Staff.
Not Substantially Equivalent DocumentN/AN/ANot Releasable
Patient RecordsOnly releasable through the FOI Staff.Only releasable through the FOI Staff.Only releasable through the FOI Staff.
PMA SupplementsOnly releasable through the FOI Staff.N/AN/A
Recession LettersOnly releasable through the FOI Staff, after recession is effectiveOnly releasable through the FOI Staff, after recession is effectiveOnly releasable through the FOI Staff, after recession is effective
Reviewer's NotesOnly releasable through the FOI Staff.Not ReleasableOnly releasable through the FOI Staff.
Substantially Equivalent LetterN/AN/AAvailable on the Internet as of July 1997, otherwise only releasable through the FOI Staff.
Summary of Safety and Effectiveness (SS&E)Approvals after September 1996 are available on the Internet, otherwise releasable through ODE or Dockets Management (with a Docket Number).N/AAvailable on the Internet for 510(K)'s found SE after March 1996. Note that the SS&E were not required prior to April 18, 1991.
Withdrawn SubmissionNot ReleasableN/ANot Releasable
Withdrawn LetterNot ReleasableNot ReleasableNot Releasable
Other Documents of Interest:
  • Blue Book Memo - Releasable from DSMICA or Internet
  • Guidance Documents - Releasable from DSMICA or Internet
  • Panel Meetings/Transcripts/Minutes:
    • Open -
      • Minutes: available after July 1996, can be found on the Internet, all minutes may be obtained through Dockets Management
      • Transcripts: can be obtained through Dockets Management
    • Closed - Not Releasable

The FOI Staff can be reached by calling 301-796-5897 or by mail at 10903 New Hampshire Avenue, Building 66, Room 5217; Silver Spring, MD 20993-0002. A Handbook for Requesting Information and Records from FDA is available on the internet.