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COMMON QUESTIONS
regulatory & clinical Questions cLARIFIED
Whether you are an emerging medical device or drug company, we're here to help.
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Medical device Clinical
Biopharma Clinical
Medical Device Regulatory
Biopharma Regulatory
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?
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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?
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What information should be included in the summary of clinical study findings?
What is an Exploratory IND approach?
What is the FDA’s policy regarding charging for investigational drugs and biologics?
What is the FDA’s policy regarding charging for investigational medical devices and radiological health products?
What level of detail is necessary in describing a clinical study?
What must a sponsor do to obtain authorization to continue charging for an investigational drug for expanded access use beyond the duration of its existing charging authorization?
What requirements must a sponsor satisfy to charge for expanded access use?
What supporting information is necessary for FDA acceptance of a foreign clinical studies not conducted under an IND?
What type of clinical information should be included in an IND submission?
What types of clinical studies should be included in your FDA submission?
What types of studies are generally NOT exempt from IND regulations?
What types of studies are generally exempt from IND regulation?
When a sponsor uses its own investigational drug in a clinical trial, what requirements must the sponsor satisfy to charge for the drug?
When and why does the Form FDA 1572 need to be completed by an investigator?
When can you receive an emergency exemption from prospective IRB approval?
When can you receive exception from informed consent for planned emergency research?
When can you receive exception from informed consent requirements?
When must a Form 1572 be updated or a new Form 1572 completed and signed by an investigator to reflect new or changed information?
When should food-effect bioavailability (BA) and bioequivalence (BE) studies be conducted?
Previous
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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?
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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?
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