Device Approval: Process that is gone through in order for a device to receive approval by a government regulatory agency. This includes any required preclinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance. It is not restricted to FDA.Drug Approval: Process that is gone through in order for a drug to receive approval by a government regulatory agency. This includes any required pre-clinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance of the drug.United States Food and Drug Administration: An agency of the PUBLIC HEALTH SERVICE concerned with the overall planning, promoting, and administering of programs pertaining to maintaining standards of quality of foods, drugs, therapeutic devices, etc.Equipment Safety: Freedom of equipment from actual or potential hazards.Equipment Design: Methods of creating machines and devices.Equipment and Supplies: Expendable and nonexpendable equipment, supplies, apparatus, and instruments that are used in diagnostic, surgical, therapeutic, scientific, and experimental procedures.Intrauterine Devices: Contraceptive devices placed high in the uterine fundus.Ethics Committees, Research: Hospital or other institutional committees established to protect the welfare of research subjects. Federal regulations (the "Common Rule" (45 CFR 46)) mandate the use of these committees to monitor federally-funded biomedical and behavioral research involving human subjects.United StatesProduct Surveillance, Postmarketing: Surveillance of drugs, devices, appliances, etc., for efficacy or adverse effects, after they have been released for general sale.Ethics Committees: Committees established by professional societies, health facilities, or other institutions to consider decisions that have bioethical implications. The role of these committees may include consultation, education, mediation, and/or review of policies and practices. Committees that consider the ethical dimensions of patient care are ETHICS COMMITTEES, CLINICAL; committees established to protect the welfare of research subjects are ETHICS COMMITTEES, RESEARCH.Device Removal: Removal of an implanted therapeutic or prosthetic device.Ethical Review: A formal process of examination of patient care or research proposals for conformity with ethical standards. The review is usually conducted by an organized clinical or research ethics committee (CLINICAL ETHICS COMMITTEES or RESEARCH ETHICS COMMITTEES), sometimes by a subset of such a committee, an ad hoc group, or an individual ethicist (ETHICISTS).Orphan Drug Production: Production of drugs or biologicals which are unlikely to be manufactured by private industry unless special incentives are provided by others.Clinical Trials as Topic: Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.Drug Industry: That segment of commercial enterprise devoted to the design, development, and manufacture of chemical products for use in the diagnosis and treatment of disease, disability, or other dysfunction, or to improve function.Septal Occluder Device: A CATHETER-delivered implant used for closing abnormal holes in the cardiovascular system, especially HEART SEPTAL DEFECTS; or passageways intentionally made during cardiovascular surgical procedures.Legislation, Drug: Laws concerned with manufacturing, dispensing, and marketing of drugs.Diagnostic Test Approval: The process of gaining approval by a government regulatory agency for DIAGNOSTIC REAGENTS AND TEST KITS. This includes any required preclinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance.Microfluidic Analytical Techniques: Methods utilizing the principles of MICROFLUIDICS for sample handling, reagent mixing, and separation and detection of specific components in fluids.Drugs, Investigational: Drugs which have received FDA approval for human testing but have yet to be approved for commercial marketing. This includes drugs used for treatment while they still are undergoing clinical trials (Treatment IND). The main heading includes drugs under investigation in foreign countries.Treatment Outcome: Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series.Hematologic Agents: Drugs that act on blood and blood-forming organs and those that affect the hemostatic system.Self-Help Devices: Devices, not affixed to the body, designed to help persons having musculoskeletal or neuromuscular disabilities to perform activities involving movement.Clinical Trials, Phase IV as Topic: Planned post-marketing studies of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques that have been approved for general sale. These studies are often conducted to obtain additional data about the safety and efficacy of a product. This concept includes phase IV studies conducted in both the U.S. and in other countries.Investigational New Drug Application: An application that must be submitted to a regulatory agency (the FDA in the United States) before a drug can be studied in humans. This application includes results of previous experiments; how, where, and by whom the new studies will be conducted; the chemical structure of the compound; how it is thought to work in the body; any toxic effects found in animal studies; and how the compound is manufactured. (From the "New Medicines in Development" Series produced by the Pharmaceutical Manufacturers Association and published irregularly.)Prostheses and Implants: Artificial substitutes for body parts, and materials inserted into tissue for functional, cosmetic, or therapeutic purposes. Prostheses can be functional, as in the case of artificial arms and legs, or cosmetic, as in the case of an artificial eye. Implants, all surgically inserted or grafted into the body, tend to be used therapeutically. IMPLANTS, EXPERIMENTAL is available for those used experimentally.Optical Devices: Products or parts of products used to detect, manipulate, or analyze light, such as LENSES, refractors, mirrors, filters, prisms, and OPTICAL FIBERS.