Clinical Information

Clinical Information means all data, reports, writings, research, and calculations performed using a medical device in scope. Output is called clinical data.

The clinical study is conducted to collect data to establish the safety and effectiveness of investigational devices.

All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated. Investigations conducted outside of the US (OUS) should follow the good clinical practice.

The types of IDE’s are:

  1. Feasibility study
  • Used to find answers to basic questions.
  • Endpoints and sample size are not statistically driven.
  • Cannot be used as primary support to marketing application.
  • Study group size between 10-40 (can be bigger)
  • Used to analyze if the clinical data obtained would justify the risk.

 

  1. Pivotal study
  • Used to support a marketing application.
  • Used to demonstrate safety and effectiveness.
  • Statistically driven endpoints and sample size
  • Both safety and effectiveness are assessed using this method
  • FDA scrutiny is more complicated.

 

Clinical tests are recommended based on various factors like device type, intended use, design, safety profile, and clinical experience to prove substantial equivalence.

The clinical protocol should include the objective of the test, test methods and procedure, study endpoints, and statistical methodology used. The study results, analyses performed, and conclusions also need to be discussed.

FDA form 3674 must be included for each clinical trial included in the submission.

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