COMMON QUESTIONS

regulatory & clinical Questions cLARIFIED

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

Do the FDA regulations permit non-local IRB review?

Does FDA prohibit direct communication between sponsors and IRBs?

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

Does FDA require the informed consent document to contain a space for assent by children?

Does a non-affiliated member need to attend every IRB meeting?

Does a physician, in private practice, conducting research with an FDA regulated product, need to obtain IRB approval?

Does a sponsor need FDA authorization to charge for the costs of drug delivery, formulation, packaging, instrumentation, monitoring, disposables, setup, and nursing care?

Does a treatment IND/IDE require prior IRB approval?

Does an IRB or institution have to compensate subjects if injury occurs as a result of participation in a research study?

Does clinical investigation of a marketed drug or biologic always require an IND submission?

Does your software device qualify for a special 510(k) submission?

Does your software device qualify for the abbreviated 510(k) program?

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

For foreign clinical studies conducted under an IND, how can an investigator sign the 1572 when the investigator knows he/she cannot commit to all of the requirements on the form, specifically IRB membership?

How are Biopharma Clinical Trials categorized?

How are IRB inspections conducted?

How are Medical Device Clinical Trials categorized?

How are clinical investigator inspections conducted?

How are study subjects made aware of possible costs associated with participation?

How can FDA protect human subjects following the discovery of clinical investigator misconduct?

How can a sponsor charge for its investigational drug in a blinded, controlled clinical trial without compromising the blind and the integrity of the clinical data generated from the trial?

How can a sponsor know whether an IRB has been inspected by FDA, and the results of the inspection?

How can informed consent be obtained from illiterate English-speaking subjects?

How can informed consent be obtained from non-English speaking subjects?

How can manufacturers identify and protect device assets and functionality?

Looking for more information?

Check out the Proxima Knowledge Base.

FRequently asked questions

Glossary of Terms

SPEAK WITH A SPECIALIST