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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
ELEMENTS PREMARKET APPROVAL (PMA) Documents 21 CFR 814.9 INVESTIGATIONAL DEVICE EVALUATION (IDE) Documents 21 CFR 812.38 PREMARKET NOTIFICATION (PMN/510k) 21 CFR 807.95
Appeals Only releasable through the FOI Staff. Only releasable through the FOI Staff. Only releasable through the FOI Staff.
Approval Letters Contained 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 Releasable Only releasable through the FOI Staff.
Approvable Letters Not Releasable N/A N/A
Bench/Clinical Data Not Releasable Not Releasable Not Releasable
Consent Forms Only releasable through the FOI Staff. Only releasable through the FOI Staff. Only releasable through the FOI Staff.
Certifications of Documents Only releasable through the FOI Staff. Only releasable through the FOI Staff. Only releasable through the FOI Staff.
Denials Only through the FOI Staff and coordinated through General Counsel Only through the FOI Staff and coordinated through General Counsel Only through the FOI Staff and coordinated through General Counsel
Labeling Contained 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 Releasable Only releasable through the FOI Staff after Predisclosure Notification
Manufacturer's Standard Operating Procedures (SOP), In-house Quality Assurance Procedures Not Releasable Not Releasable Not Releasable
Minor Deletions Only releasable through the FOI Staff. N/A Only releasable through the FOI Staff.
Not Substantially Equivalent Document N/A N/A Not Releasable
Patient Records Only releasable through the FOI Staff. Only releasable through the FOI Staff. Only releasable through the FOI Staff.
PMA Supplements Only releasable through the FOI Staff. N/A N/A
Recession Letters Only releasable through the FOI Staff, after recession is effective Only releasable through the FOI Staff, after recession is effective Only releasable through the FOI Staff, after recession is effective
Reviewer's Notes Only releasable through the FOI Staff. Not Releasable Only releasable through the FOI Staff.
Substantially Equivalent Letter N/A N/A Available 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/A Available 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 Submission Not Releasable N/A Not Releasable
Withdrawn Letter Not Releasable Not Releasable Not 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 240-276-0684 or by mail at 7520 Standish Place, HFZ - 23; Rockville, MD 20855. A Handbook for Requesting Information and Records from FDA is available on the internet (http://www.fda.gov/opacom/backgrounders/foiahand.html).

    
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