COMMON QUESTIONS

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 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 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?

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?

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 can you obtain an emergency IND?

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

How does FDA classify medical devices?

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

How does the non-local IRB obtain knowledge of local community attitudes, conditions surrounding the conduct of the research, and the continuing status of the research?

How have the FDA policies on enrollment of special populations changed?

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 animal allocation to experimental grouping be done in animal studies?

How should animal quarantine and conditioning be performed?

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

How should informed consent be documented?

How should risks be evaluated for animal studies?

How should the 1572 be completed?

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

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

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

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

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

If a site uses a receptionist to screen subjects for studies, must the script he/she uses be reviewed by the IRB?

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?

If an IRB disapproves a study submitted to it, and it is subsequently sent to another IRB for review, should the second IRB be told of the disapproval?

If an IRB uses a standard "fill-in-the-blank" consent format, does the IRB need to review the filled-out form for each study?

If your device is an In Vitro Diagnostic Device, what should you do if your device undergoes a technology, engineering, performance, or material change?

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 getting the subject to sign a consent document all that is required by the regulations?

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

Is it acceptable for the consent document to say specimens are "donated"?

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

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?

Is the purpose of the IRB review of informed consent to protect the institution or the subject?

May a clinical investigator be an IRB member?

May a hospital IRB review a study that will be conducted outside of the hospital?

May informed consent be obtained by telephone from a legally authorized representative?

May the IRB use alternate members?

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

Must an institution establish its own IRB?

Must an investigator's brochure be included in the documentation when an IRB reviews an investigational drug study?

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

Should sponsors consider anything else in deciding whether or not to conduct a study that may fall within the exercise of enforcement discretion?

Should the sponsor prepare a model informed consent document?

The FDA regulations exempt an emergency use of a test article from prospective IRB review, however, "... any subsequent use of the test article at the institution is subject to IRB review." What does the phrase "subsequent use" mean?

The informed consent regulations require the consent document to include a statement that notes the possibility that FDA may inspect the records. Is this statement a waiver of the subject's legal right to privacy?

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?

What level of detail is necessary in describing a clinical study?

What personnel are key to the success of your animal study?

What regulation describes custom devices?

What should you consider animal identification in an animal study?

What should you consider for research controls in an animal study?

What should you consider for study equipment in an animal study?

What should you consider in designing or choosing the facilities for an animal study?

What statute and regulations apply to medical device clinical investigations?

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

What types of clinical studies should be included in your FDA submission?

What types of controls are used in clinical 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 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 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?

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

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

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

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 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?

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

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

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

If your device is an In Vitro Diagnostic Device, what should you do if your device undergoes a technology, engineering, performance, or material change?

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?

Should sponsors consider anything else in deciding whether or not to conduct a study that may fall within the exercise of enforcement discretion?

What actions should you take if the change is made solely to return the system into specification of the most recently cleared device?

What actions should you take if the change is made solely to strengthen cybersecurity and does not have any other impact on the software or device?

What are all the recommended sections of a Traditional or Abbreviated 510(k) submission?

What are some additional factors to consider when determining when to submit a new 510(k) for a software change to an existing device?

What are some common reasons as to why a 510(k) submission would not be accepted?

What are some common types of software changes?

What are some guiding principles for submitting a new 510(k) after modifying a device?

What are some other types of Q-Submissions?

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

What are some uses of the Informational Meeting Q-Submission program?

What are the consequences of distributing unapproved IVDs labeled for research use only (RUO) or investigational use only (IUO)?

What are the design expectations to help manufacturers detect, respond to, and recover cybersecurity risks?

What are the impacts of any changes to risks associated with use of the device and the impacts of any changes to the risk controls for the device?

What are the qualifications for major, moderate, or minor levels of concern?

What are the refuse to accept principles?

What are the tiers for cybersecurity risk?

What can be categorized as a minor injury, and what can be considered a serious injury?

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 content should be included in a Dual Submission?

What device investigations are exempt from IDE regulation?

What device investigations are subject to IDE regulation?

What device types are appropriate for the safety and performance based pathway?

What devices does the FDA categorize as a SaMD, and how is clinical evaluation performed?

What documentation should be included for Tier 1 and Tier 2 devices?

What does the FDA consider to be valid scientific evidence?

What does verification and validation of software devices consist of?

What factors should manufacturers consider in addressing cybersecurity?

What general labeling requirements are necessary?

What happens if there is a pending 510(k) or PMA application for the same device with the same indications for use?

What happens if you submit your device for a 510(k) clearance, and it gets denied?

What happens when the intended use of the proposed device is different from that of which appears on the labeling?

What information is required for a De Novo request?

What information should be included in a Q-Submission?

What information should be included in the 510(k) Cover Letter, 510(k) Summary, and 510(k) Statement?

What information should be included in the labeling regarding cybersecurity risks?

What information should be included in the risk management documentation in regards to cybersecurity risks?

What information should be included in the verification and validation documentation?

What is a De Novo request and when are they used?

What is a Pre-Sub?

What is a Study Risk Determination?

What is a Submission Issue Request (SIR)?

What is an Informational Meeting?

What is an architecture design chart?

What is considered to be a “trustworthy device”?

What is included in a De Novo Pre-Sub?

What is the abbreviated 510(k) program?

What is the application process for breakthrough devices subject to PMA?

What is the application process for devices intended for small patient populations subject to PMA?

What is the definition of a noninvasive device?

What is the difference between Form FDA 3601, 3514, 3881, and 3454?

What is the difference between a 510(k) and a CLIA Waiver?

What is the difference between acceptance review and substantive review during the review of a De Novo request?

What is the difference between bench, animal, and clinical testing? Are all these forms of performance testing required?

What is the documentation required for a software-related submission?

What is the format of a Q-Submission meeting?

What is the relationship between hazards and harm?

What is the special 510(k) program?

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

What is the typical review process of a SIR?

What regulation applies to research use only (RUO) or investigational use only (IUO) In Vitro Diagnostic (IVD) products?

What should IRBs do when reviewing the types of IVD studies that are the focus of this guidance?

What should be documented in the software requirements specification?

What should be included in a binary qualitative test?

What should be included in a quantitative test?

What should be included in a special 510(k) submission?

What should be included in a traceability analysis?

What should be included in an abbreviated 510(k) submission?

What should be included in documentation for device changes?

What should be included in study designs for comparison and reproducibility studies that support a Dual Submission?

What should be included in system diagrams, in regards to cybersecurity risks?

What should be included in your device hazard analysis for a software device?