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Compliance In Focus
Posted by John Lehmann on Thu, Oct 20, 2016

Comparing Drug and Medical Device Clinical Trials

Comparing_drug_medical_device_trials.jpgUnderstanding the similarities and appreciating the differences of drug and medical device clinical trials is important. A well-organized, controlled clinical trial can save time and money. Additionally, the faster and more accurately a trial is performed, the faster the test article can be introduced to the market and begin helping the community.

Read on to learn the similarities and differences between drug and medical device clinical trials.

The Differences between Drug and Medical Device Clinical Trials

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The Similarities between Drug and Medical Device Clinical Trials

Both drug and device clinical trials require adherence to the following regulations:

  • 21 CFR 11 - Electronic medical records
  • 21 CFR 50 - Human subject protection
  • 21 CFR 54 - Financial disclosure
  • 21 CFR 56 - Institutional Review Board (IRB) requirements

On the other hand, drug trials must abide by 21 CFR 312 (investigational new drug application) but device trials do not. Additionally, device clinical trials must abide by 21 CFR 812 (investigational device exemptions) whereas drug trials do not.

However, these two regulations have a number of similarities, some of which are outlined below:

  1. The appropriate submission must be made to the FDA before beginning an investigation.
  2. Amendments are required when changes are made.
  3. Annual updates on study progress are mandatory.
  4. Both sponsor and investigator responsibilities are described.
  5. Investigation must be conducted in compliance with the investigational plan, signed agreement, federal regulations and conditions of approval imposed by the IRB.
  6. Investigation must be properly monitored.
  7. IRB approval must be obtained prior to beginning the investigation.
  8. Labeling requirements are specified.
  9. Significant new information must be provided to subjects.
  10. Sponsors must provide information to investigators.

Drug and device clinical trials have several similarities and differences, but the end goal is the same: introduce safe and effective products to the public as quickly as possible.

Conducting Global Clinical Trials


John Lehmann is the director of business development of IMARC Research, a clinical research organization (CRO) that specializes in medical device trials. IMARC Research assists study sponsors with clinical monitoring, auditing, training, consulting, project management and more. To learn more, visit imarcresearch.com.

Topics: Medical Devices

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