Frequently Asked Questions

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

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

Which party is responsible for maintaining and communicating confidential medical records and information during a study?

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

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

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?

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

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

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

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

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

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

How can manufacturers identify and protect device assets and functionality?

What is considered to be a “trustworthy device”?

What are the tiers for cybersecurity risk?

What is the definition of a noninvasive device?

What information is required for a De Novo request?

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 are the refuse to accept principles?

What is included in a De Novo Pre-Sub?

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

When performing a benefit-risk determination, what factors does the FDA consider?

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

What is the special 510(k) program?

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

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

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

What types of certifications and statements must be included in a 510(k) submission?

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

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

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

What should you do if your device undergoes a material change?

What should you do if your device undergoes a technology, engineering, or performance change?

What should you do if your device undergoes a labeling change?

When a secondary research facility is used, how should informed research consent be documented?

What happens when a study subject at one institution is admitted to a second institution for a reasonably foreseeable reason and as an anticipated part of the study protocol?

What happens when a study subject at one institution is admitted to another facility for treatment / hospitalization not related to the research?

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

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

Are there alternatives to obtaining informed consent from a subject?

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?

What is an "assurance" or a "multiple project assurance," and are assurances required by the FDA?

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

What elements must be included in the Informed Consent Document?

What is the Consent Process?

What device investigations are exempt from IDE regulation?

What device investigations are subject to IDE regulation?

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

What is the purpose of the medical device tracking regulation, according to CAPA?

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

What happens if there are corrections and removals to a medical device, according to CAPA?

What is the purpose of MDR?

What is the purpose of CAPA?

What is the FDA's Corrective and Preventive Actions (CAPA) system procedure?

What is a Pre-Market Approval (PMA)?

What is the purpose of an FDA IND application?

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

What is the FDA's ASCA pilot program?

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

Are there development specifications for the ASCA program?

What are the 5 main goals of the ASCA pilot program?

What happens with the FDA when there are changes and updates to a SaMD device?

When should food-effect bioavailability (BA) and bioequivalence (BE) studies be conducted?

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

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

What are the different endpoints for a clinical study?

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

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

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

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

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 will occur when an investigator is disqualified?

What is a Part 16 hearing?

What is a Notice of an Opportunity for Hearing?

What is a consent agreement?

What is a NIDPOE?

What supporting information is necessary for FDA acceptance of a foreign clinical studies not conducted under an IND?

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

When will waivers be needed for foreign clinical studies not conducted under an IND?

What does FDA consider an “adequately constituted” IEC?

Will FDA need access to case records maintained by the investigator or additional background data such as hospital or other institutional records?

Would a study report “Synopsis” provide a sufficiently detailed summary of the protocol and study results for FDA acceptance of foreign clinical studies not conducted under an IND?

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?

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

What types of studies are generally NOT exempt from IND regulations?

What types of studies are generally exempt from IND regulation?

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

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

What will FDA lift a clinical hold that was imposed to protect subjects from investigator misconduct?

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

Under what circumstances would FDA consider imposing a clinical hold following discovery of clinical investigator misconduct?

What is a clinical hold?

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

What actions can FDA take to address clinical investigator misconduct?

What are a clinical investigator's responsibilities?

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

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