FDA Home Page | CDRH Home Page | Search | A-Z Index | ||
|
||||
|
||||
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 |
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).
Updated October 25, 2007
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH