COMMON QUESTIONS

What is the purpose of an FDA IND application?

Why is defining the "Intended Use/Purpose" with the FDA important for SaMD devices?

21 CFR 50.27(a) requires that a copy of the consent document be given to the person signing the form. Does this copy have to be a photocopy of the form with the subject's signature affixed?

21 CFR 56.115(a)(1) requires that the IRB maintain copies of "research proposals reviewed." Is the "research proposal" the same as the formal study protocol that the investigator receives from the sponsor of the research?

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

Are FDA inspections of clinical investigator sites announced or unannounced?

Are IRBs Inspected by FDA?

Are annual IRB reviews required when all studies are reviewed by the IRB each quarter?

Are placebo-controlled studies effective?

Are research sponsors obligated to determine IRB compliance with regulations?

Are research sponsors permitted to contact the Institutional Review Board (IRB) directly?

Are there activities that are prohibited by sponsors of an investigational device?

Are there alternatives to obtaining informed consent from a subject?

Are there any regulations that require clinical investigators to report to the IRB when a study has been completed?

Are there any screening procedures that could be performed without first obtaining consent?

Are there development specifications for the ASCA program?

Are there different goals for IVD studies compared to other device studies?

Can a physician use an unapproved device in an emergency?

Can a sponsor conduct a foreign clinical study under an IND, and if so, must investigators who conduct studies outside of the United States sign a 1572?

Can subjects be screened prior to initiation of a clinical study to determine eligibility? Is informed consent required for screening?

Can testing performed by an ASCA-accredited testing laboratory be used to support a premarket submission?

Can you add additional testing on the same subject to the dataset, particularly when it is hard to find study subjects?

Could the software change significantly affect clinical functionality or performance specifications that are directly associated with the intended use of the device?

Do Radioactive Drug Research Committees (RDRCs) have authority to approve initial clinical studies in lieu of an IND?

Do clinical screening procedures require IRB oversight?