Regulatory & Clinical FAQs

regulatory & clinical Questions cLARIFIED

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

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?

Are placebo-controlled studies effective?

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?

How do you design a reproducibility study?

How should animal allocation to experimental grouping be done in animal studies?

How should animal quarantine and conditioning be performed?

How should risks be evaluated for animal studies?

How should you use animal studies in preparation for a regulatory submission?

In selecting animal models, what should your rationale include?

In what circumstances does FDA intend to exercise enforcement discretion as to the requirements for informed consent for use of specimens in FDA regulated IVD studies?

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 active-control clinical trials?

What are some factors to consider in the evaluation of how a device affects an animal?

What are some general principles to consider when developing animal study protocols for medical devices?

What are some popular post-mortem imaging and assessment methods?

What are some specific recommendations for animal study monitoring?

What are the different endpoints for a clinical study?

What are the elements of an animal study?

What are the recommendations for food, water, and basic husbandry within animal studies?

What information should be included in the description of a clinical study design?

What information should be included in the summary of clinical study findings?

What is a typical study schedule for animal studies?

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?

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

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

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 study subjects made aware of possible costs associated with participation?

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 does a sponsor submit information to FDA about a foreign clinical study that was not conducted under an IND?

How is payment to research subjects for participation in studies viewed and assessed by IRBs?

How long may a sponsor charge for an investigational drug for expanded access use after FDA authorizes the charging?

How should gender differences be factored into the clinical investigation process?

How should the 1572 be completed?

How should the risk/benefit analysis be performed in the practice of oncology?

If a sponsor chooses to conduct a foreign clinical study under an IND and the investigators comply with ICH E6 GCP Consolidated Guidance, would non-US investigators also be in compliance with FDA’s IND requirements?

If a sponsor’s own approved drug is used as concomitant therapy during a clinical trial intended to evaluate another drug, should the sponsor obtain authorization to charge for the drug used?

Is it permitted to incentivize participants to complete the study by offering more money for completion?

Must foreign clinical study sites in a multinational study that includes domestic sites be conducted under an IND?

Under 21 CFR 312.8, who requests authorization from FDA to charge for an investigational drug for use under an IND?

What are the different endpoints for a clinical study?

What are the requirements if a physician decides to use a product for an indication not in the approved labeling when the intent is the practice of medicine?

What are the requirements that allow planned studies to be exempt from IND requirements?

What constitutes extraordinary cost?

What costs can a sponsor recover when charging for an investigational drug for expanded access use under 21 CFR part 312, subpart I?

What information is a sponsor required to submit to support its cost calculation?

What information should be included in the description of a clinical study design?

What is the purpose of an FDA IND application?

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

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

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

Are there development specifications for the ASCA program?

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

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?

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

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

How can manufacturers identify and protect device assets and functionality?

How can you determine if an in vitro diagnostic (IVD) device is of significant risk?

How can you determine the extent of risks and harms associated with a device change?

How can you determine the level of concern of your software device?

How do 510(k) submissions review measures taken towards patient safety?

How do you design a comparison study?

How do you design a reproducibility study?

How do you determine if an in vitro diagnostic (IVD) study is applicable for an IDE regulation?

How do you determine substantial equivalence for a 510(k) submission?

How do you prepare a 510(k) using the safety and performance based pathway?

How do you report corrections or removals for a medical device to the FDA?

How do you submit a 510(k) using the safety and performance based pathway?

How does FDA classify medical devices?

How should unresolved anomalies, like bugs or defects, be documented?

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

How can you obtain an emergency IND?

How should you link your Q-Submission to future regulatory submissions?

How will your Q-Submission be tracked by the FDA?

Is the name and address of the research facility a sufficient description for supporting information intended for FDA acceptance of foreign clinical studies not conducted under an IND?

Under 21 CFR 312.8, who requests authorization from FDA to charge for an investigational drug for use under an IND?

What are some types of interactions that fall outside of the Q-Submission program?

What are the criteria for a waiver intended for foreign clinical studies not conducted under an IND?

What are the requirements that allow planned studies to be exempt from IND requirements?

What content and review process are expected for a Study Risk Determination Request?

What content and review process are expected for an Informational Meeting?

What content is expected to be included within a Pre-Submission?

What content is expected to be included within a Submission Issue Request (SIR)?

What documentation should the sponsor or applicant provide regarding investigator qualifications?

What does FDA consider an “adequately constituted” IEC?

What information should be included in a Q-Submission?

What is a Group C treatment IND?

What is a Pre-Sub?

What is a Submission Issue Request (SIR)?

What is a clinical hold?

What is a treatment IND?

What is the format of a Q-Submission meeting?

What is the typical review process of a Pre-Sub?

What is the typical review process of a SIR?

What steps will FDA take before imposing a clinical hold to protect subjects from investigator misconduct?

COMMON QUESTIONS