Suggested Format for IDE Progress Report

Center for Devices and Radiological Health, U.S. Food and Drug Administration

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This guidance was written prior to the February 27, 1997 implementation of FDA's Good Guidance Practices, GGP's. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be updated in the next revision to include the standard elements of GGP's.

Suggested Format For IDE Progress Report

Basic Elements

IDE Number
Device name and indication(s) for use
Sponsor's name, address, phone number, and fax
Contact person

Study Progress
(Data from beginning of the study should be reported, unless otherwise indicated.)

Brief summary of the study progress in relation to the investigational plan
Number of investigators/investigational sites (attach list of investigators)
Number of subjects enrolled (by indication or model)
Number of devices shipped
Brief summary of results
Summary of anticipated and unanticipated adverse effects
Description of any deviations from the investigational plan by investigators (since last progress report)

Risk Analysis

Summary of any new adverse information (since the last progress report) that may affect the risk analysis; this includes preclinical data, animal studies, foreign data, clinical studies, etc.
Reprints of any articles published from data collected from this study
New risk analysis, if necessary, based on new information and on study progress

Other Changes

Summary of any changes in manufacturing practices and quality control (including changes not reported in a supplemental application)
Summary of all changes in the investigational plan not required to be submitted in a supplemental application

Future Plans

Progress toward product approval, with projected date of PMA or 510(k) submission
Any plans to change the investigation, e.g., to expand the study size or indications, to discontinue portions of the investigation or to change manufacturing practices (NOTE: Actual proposals for these changes should be made in a separate supplemental application).

6/1/1996

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Center for Devices and Radiological Health / CDRH