Sponsors are encouraged to submit pre-IDE submissions to the ODE reviewing division while the sponsor is preparing a formal IDE submission whenever the sponsor requires informal FDA guidance on troublesome parts of the IDE application, for example, clinical protocol design, preclinical testing proposal, etc. Pre-IDE submissions are logged into the pre-IDE tracking system by the […]

Two types of pre-IDE meetings are possible: meetings in which FDA provides “informal guidance” and meetings where FDA provides “formal guidance” as provided for in Section 201 of the FDA Modernization Act of 1997. a. “Informal Guidance” Meetings. Sponsors are encouraged to meet with the Office of Device Evaluation (ODE), Reviewing Division before the IDE […]

• Investigational Device Exemption (IDE) – 21CFR Part 812 • IDE content • Institutional Review Board (IRB) 22.6.1 An Investigational Device Exemption Overview An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a PMA application or a […]

Usually, a Phase III study which presents evidence-based data that the FDA will rely on when deciding whether or not to approve a drug or device. A pivotal study will generally be well-controlled, randomized, statistically powered to adequate size, and whenever possible, double-blind. It represents the optimized drug or device as intended for commer­cialization, along […]

A pilotstudy is a preliminary study to the larger study. It is typically limited in the num­ber of subjects than you plan to include in the full study, or you may limit it because your scope is smaller in some other way; for example, the range of types of subjects may be more limited, or […]

A research study is a controlled exploratory study which incorporates a formal research design to test a hypothesis with validated measures. These studies should document that this research can be replicated or generalizable to other settings. The design allows for a statistical test of the specific differences found between the two groups on a validated […]

Clinical trials are conducted in phases. Each phase of a trial has a different purpose and helps scientists to answer specific questions. While small, early phase trials may be conducted by individuals or small groups of phy­sicians, larger trials are typically conducted by hospitals, pharmaceutical companies, or device manufacturers. If a therapy successfully passes through […]

There are different types of clinical trials: treatment, prevention, diagnostic, screening, and quality of life trials—and the trials are conducted in progressive phases (I-IV). To ensure that no one can influence the results of a study, clinical trials employ a range of specialized testing mechanisms intended to prevent bias and provide reliable results: [8] In […]

A clinical trial (also called clinical research) is a research study using human volunteers designed to determine the safety and effectiveness of a drug, biologic (such as a vaccine), device (such as prosthesis) or other treatment or behavioral intervention. Carefully con­ducted clinical trials are the fastest and safest way to find treatments that work in […]