IDE Application: Common Problems with Original IDE Applications

The sponsor should assure that the device, all preclinical testing, and the investigational plan are described and provide adequate justification for the initiation of the clinical trial. Submitters should avoid submitting the IDE application prematurely. There are three common areas that are frequently deficient in IDE applications.

• Inadequate report of prior investigations
• Inadequate investigational plan
• Inadequate/incomplete design and manufacture

Common deficiencies with report of prior investigations

A report of prior investigations must include reports of all prior clinical, animal, and laboratory testing of the device. It should be comprehensive and adequate to justify the proposed investigation.

1. Laboratory Studies
• inadequate description of methods
• inadequate or no summary or conclusion
• conclusions not supported by data
2. Reports of Animal Studies
• no rationale for animal selection
• no statistical justification for the number of animals selected
• inappropriate duration or follow-up
• failure to address compliance with Good Laboratory Practices for Nonclinical Studies, 21 CFR 58
3. Reports of Prior Publications
• incomplete searches
• copies of relevant publications not included
• omission of adverse information
• failure to identify relevant parts or information and to summarize

Common deficiencies with investigational plan

• questionable scientific soundness
• failure to clearly develop or define study objectives
• inadequate description of the protocol
• failure to identify all risks
• failure to develop proper monitoring procedures

Common deficiencies with design and manufacture

• Design: Inadequate characterization or description of the device and its operation due to inadequate or omitted:
• Design/engineering drawing of device
• Rationale for device design
• Device and performance specifications
• Description of materials (including biocompatibility information)
• Description of function - how does device and/or components/subsystems work together to achieve desired function
• Validation testing for subsystems and main system
• Manufacture: Inadequate or missing description of the controls used to ensure that the devices are produced consistently and as designed.