COMMON QUESTIONS

regulatory & clinical Questions cLARIFIED

Whether you are an emerging medical device or drug company, we're here to help.

Approved, Granted or Cleared – which term for what pathway?

Are IRBs Inspected by FDA?

Can a physician use an unapproved device in an emergency?

Does FDA require IRB review of off-label use of a legally marketed device?

Explain the difference between Significant Risk (SR) vs. Non-Significant Risk (NSR) devices

How are Biopharma Clinical Trials categorized?

How are IRB inspections conducted?

How are Medical Device Clinical Trials categorized?

How does FDA classify medical devices?

Is informed consent required when treating/diagnosing a patient with an HUD?

Must an IRB review a study conducted after submission of 510(k) to FDA but prior to FDA’s decision on the submission?

What are some common deficiencies that have been observed by FDA investigators during a clinical investigator inspection?

What happens after an IRB inspection?

What happens after the FDA inspects a clinical investigator?

What may the FDA do until the IRB or parent institution takes appropriate corrective action?

What regulation describes custom devices?

What statute and regulations apply to medical device clinical investigations?

What type of device studies do the IDE regulations (21 CFR 812) cover?

When are IRB inspections conducted?

Can a physician use an unapproved device in an emergency?

Does FDA require IRB review of off-label use of a legally marketed device?

Explain the difference between Significant Risk (SR) vs. Non-Significant Risk (NSR) devices

How are Medical Device Clinical Trials categorized?

Is informed consent required when treating/diagnosing a patient with an HUD?

Must an IRB review a study conducted after submission of 510(k) to FDA but prior to FDA’s decision on the submission?

What regulation describes custom devices?

What statute and regulations apply to medical device clinical investigations?

What type of device studies do the IDE regulations (21 CFR 812) cover?

How are Biopharma Clinical Trials categorized?

Approved, Granted or Cleared – which term for what pathway?

How does FDA classify medical devices?

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