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 DICE or Internet
• Guidance Documents - Releasable from DICE 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 Division of Information Disclosure 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.