What is the purpose of a FDA Form 3674?

What is the purpose of a FDA Form 3674?

One purpose of the certification is to require the submitter to confirm compliance with all applicable requirements of Title VIII, including applicable implementing regulations, e.g., the requirement to register applicable clinical trials.

Is ClinicalTrials.gov required?

You must use ClinicalTrials.gov to fulfill the requirements of FDAAA 801 (PDF). FDAAA 801 requires Responsible Parties to submit clinical trial information to the Director of the National Institutes of Health (NIH) for inclusion in the registry and results database established via ClinicalTrials.gov.

Is FDA approval required for clinical trials?

Clinical trials are an integral part of new product discovery and development and are required by the Food and Drug Administration before a new product can be brought to the market.

What needs to be registered on ClinicalTrials?

Which Trials Must Be Registered on ClinicalTrials.gov? Registration is required for studies that meet the definition of an “applicable clinical trial” (ACT) and either were initiated after September 27, 2007, or initiated on or before that date and were still ongoing as of December 26, 2007.

Who created databank for clinical trials?

History. As a result of pressure from HIV-infected men in the gay community, who demanded better access to clinical trials, the U.S. Congress passed the Health Omnibus Programs Extension Act of 1988 (Public Law 100-607) which mandated the development of a database of AIDS Clinical Trials Information Services (ACTIS).

What needs to be posted on ClinicalTrials?

ClinicalTrials.gov allows the registration of clinical studies with human subjects that assess biomedical and/or health outcomes and that conform to: Any applicable human subject or ethics review regulations (or equivalent) Any applicable regulations of the national or regional health authority (or equivalent)

Do I need to register feasibility study?

Hence, within this definition, many pilot studies, feasibility studies, and studies that use a pretest–posttest design without a control or comparison group should be registered.

What are the requirements of a clinical trial?

Biomedical or social/behavioral research is considered a “clinical trial” when it meets certain criteria, which typically involve: Prospective assignment of participants to one or more interventions (which may include placebo or other control);

What requirements must be met to conduct a clinical trial?

All clinical trials have guidelines, called eligibility criteria, about who can participate. The criteria are based on such factors as age, sex, type and stage of disease, previous treatment history, and other medical conditions.

What is a 510 K form?

A 510(k) is a submission containing information required under 21 CFR 807.87. All 510(k)s are based on the concept of substantial equivalence (SE) to a legally marketed device, also referred to as a predicate. All 510(k)s provide a comparison between the device to be marketed and the predicate device or devices.