• Components of a 510(k) application • Special requirements for OTC clearance A brief summary of those requirements outlined under the Radiation Control for Health and Safety Act of 1968 that apply to manufacturers of laser products are presented here. The reader is encouraged to review the regulations in their entirety to foster complete com­prehension […]

No clinical investigator may involve a human being as a subject in research unless the investigator has obtained the legally effective informed consent from the subject. Informed Consent is a written notification to human subjects involved in clinical investigations that provides them with sufficient opportunity to consider whether or not to voluntarily partici­pate in the […]

The logistics of IRB review varies from institution to institution. The major principles underlying IRB review, however, do not. First, the IRB must make a decision based on common sense and sound professional judgment as to whether or not the proposed research places the subject “at risk”. A subject is considered to be at risk […]

The National Commission in its report on IRBs 1 08 articulated the primary purpose of the IRB: Investigators should not have sole responsibility for determining whether research involving human subjects fulfills ethical standards. Others who are independent of the research must share this responsibility, because investiga­tors are always in positions of potential conflict by virtue […]

The composition of the IRB is specified in the Department of Health & Human Services (DHHS) regulations.107 The IRB must be comprised of male and female members from diverse backgrounds who possess the professional competence necessary to review the specific research activities submitted to the Board. In addition, the IRB should reflect an appropriate racial […]

Under FDA regulations, an IRB is an appropriately constituted group that has been for­mally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifica­tions in (to secure approval), or disapprove research. This group review serves an important role in the protection […]

a. Prior Investigations (21 CFR §812.27). This section should summarize any prior clinical testing experience by the sponsor with the test device. Additional information could be included from bench, in vitro and in vivo tests that support the proposed clinical trial. Relevant literature data on safety and effectiveness should also be summarized, including a bibliography […]

a. Purpose of the Clinical Trial. This section describes broad study goals, as well as specific aims of the investigation. A background and rationale for conducting the study is generally helpful for the FDA to understand the broader purpose and determine risk/bene – fits of the investigation. The background information may include earlier studies conducted […]

An IDE is designed to provide sufficient information which FDA can use to make a determination on whether to approve or disapprove a clinical trial. The following are key components of an IDE for an investigational device with a focus on light-based systems.