The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
Cranial electrotherapy stimulation (CES) is a form of neurostimulation that delivers a small, pulsed, alternating current via electrodes on the head. CES is used with the intention of treating a variety of conditions such as anxiety, depression and insomnia. CES has been suggested as a possible treatment for headaches, fibromyalgia, smoking cessation, and opiate withdrawal, but there is little evidence of effectiveness for many of these conditions and the evidence for use in acute depression is not sufficient to justify it.
Generally recognized as safe (GRAS) is a United States Food and Drug Administration (FDA) designation that a chemical or substance added to food is considered safe by experts under the conditions of its intended use. An ingredient with a GRAS designation is exempted from the usual Federal Food, Drug, and Cosmetic Act (FFDCA) food additive tolerance requirements. The concept of food additives being "generally recognized as safe" was first described in the Food Additives Amendment of 1958, and all additives introduced after this time had to be evaluated by new standards. The FDA list of GRAS notices is updated approximately each month, as of 2021.
In food safety, the concept of substantial equivalence holds that the safety of a new food, particularly one that has been genetically modified (GM), may be assessed by comparing it with a similar traditional food that has proven safe in normal use over time. It was first formulated as a food safety policy in 1993, by the Organisation for Economic Co-operation and Development (OECD).
The United States Federal Food, Drug, and Cosmetic Act is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. The FDA's principal representative with members of congress during its drafting was Charles W. Crawford. A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations.
The Food and Drug Administration's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. Some 30% or less of initial drug candidates proceed through the entire multi-year process of drug development, concluding with an approved NDA, if successful.
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase.
An investigational device exemption (IDE) allows an investigational device to be used in order to collect safety and effectiveness data required to support a premarket approval (PMA) application or a premarket notification [510(k)] submission to Food and Drug Administration (FDA). Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)'s require clinical data to support the application. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated.
A drug recall removes a prescription or over-the-counter drug from the market. Drug recalls in the United States are made by the FDA or the creators of the drug when certain criteria are met. When a drug recall is made, the drug is removed from the market and potential legal action can be taken depending on the severity of the drug recall.
The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the U.S. Food and Drug Administration (FDA), which is a part of the U.S. Department of Health and Human Services. The current Director of CBER is Peter Marks, M.D., PhD. CBER is responsible for assuring the safety, purity, potency, and effectiveness of biologics and related products. Not all biologics are regulated by CBER. Monoclonal antibodies and other therapeutic proteins are regulated by the FDA Center for Drug Evaluation and Research (CDER).
The Center for Devices and Radiological Health (CDRH) is one of six product centers of the U.S. Food and Drug Administration (FDA), an agency that is part of the U.S. Department of Health and Human Services (HHS). CDRH is responsible for ensuring that patients and providers in the U.S. have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products.
President of the United States George W. Bush signed the Food and Drug Administration Amendments Act of 2007 (FDAAA) on September 27, 2007. This law reviewed, expanded, and reaffirmed several existing pieces of legislation regulating the FDA. These changes allow the FDA to perform more comprehensive reviews of potential new drugs and devices. It was sponsored by Reps. Joe Barton and Frank Pallone and passed unanimously by the Senate.
The following outline is provided as an overview of and topical guide to clinical research:
An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified by 21 U.S.C. § 360bbb-3, to allow the use of a drug prior to approval. It does not constitute approval of the drug in the full statutory meaning of the term, but instead authorizes the FDA to facilitate availability of an unapproved product, or an unapproved use of an approved product, during a declared state of emergency from one of several agencies or of a "material threat" by the Secretary of Homeland Security.
The United States Food and Drug Administration Modernization Acts (FDAMA) are amendments to the Federal Food, Drug, and Cosmetic Act, which regulated products by the FDA. The first bill, the FDA Modernization Act of 1997, reduced the timeline for approving new pharmaceutical drugs. It also loosened rules around broadcast pharmaceutical advertising.
The Food and Drug Administration is a federal agency of the United States, formed in 1930.
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012. It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics. It also creates the breakthrough therapy designation program and extends the priority review voucher program to make eligible rare pediatric diseases. The measure was passed by 96 senators voting for and one voting against.
Safe Medical Device Amendments of 1990 or Safe Medical Devices Act sanctioned progressive reporting and tracking rules for medical devices classified by the Medical Device Regulation Act. The Act mandates reporting requirements by medical device manufacturers regarding adverse safety events and product effectiveness of devices classified as substantially equivalent to Class III medical devices. The United States Statute established the Health and Human Services Office of International Relations and a U.S. Food and Drug Administration office for regulatory activities concerning healthcare products which are considered a combinational biological, device, or drug product. The Act of Congress transferred the electronic product radiation control provisions established by the Radiation Control for Health and Safety Act.
Due to the many regulations in the industry, the design of medical devices presents significant challenges from both engineering and legal perspectives.
The Over-the-Counter Hearing Aid Act of 2017 was a law passed by the 115th United States Congress as a rider on the FDA Reauthorization Act of 2017. It created a class of hearing aids regulated by the Food and Drug Administration (FDA) available directly to consumers without involvement from a licensed professional. Regulations for this new class of hearing aid are expected to be released by the end of 2020.
