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FDA Center For Devices And Radiological Health
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. Examples of products that CDRH regulates include medical devices ranging from tongue depressors and personal protective equipment (PPE) to pacemakers and robotic surgical systems, and medical and non-medical radiation-emitting electronic products such as lasers, x-ray systems, ultrasound equipment, microwave ovens, and color televisions. As of October 2024, the Director of CDRH is Michelle Tarver M.D., Ph.D. Organization structure CDRH consists of seven offices that work in collaboration to assure that consumers have access to safe and effective medical products. * Of ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United States Department Of Health And Human Services
The United States Department of Health and Human Services (HHS) is a cabinet-level executive branch department of the US federal government created to protect the health of the US people and providing essential human services. Its motto is "Improving the health, safety, and well-being of America". Before the separate federal Department of Education was created in 1979, it was called the Department of Health, Education, and Welfare (HEW). HHS is administered by the secretary of health and human services, who is appointed by the president with the advice and consent of the United States Senate. The United States Public Health Service Commissioned Corps, the uniformed service of the PHS, is led by the surgeon general who is responsible for addressing matters concerning public health as authorized by the secretary or by the assistant secretary for health in addition to his or her primary mission of administering the Commissioned Corps. History Federal Security Agency ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Tampons
A tampon is a menstrual product designed to absorb blood and vaginal secretions by insertion into the vagina during menstruation. Unlike a pad, it is placed internally, inside of the vaginal canal. Once inserted correctly, a tampon is held in place by the vagina and expands as it soaks up menstrual blood. As tampons also absorb the vagina's natural lubrication and bacteria in addition to menstrual blood, they can increase the risk of toxic shock syndrome by changing the normal pH of the vagina and increasing the risk of infections from the bacterium ''Staphylococcus aureus''. TSS is a rare but life-threatening infection that requires immediate medical attention. The majority of tampons sold are made of blends of rayon and cotton, along with synthetic fibers. Some tampons are made out of organic cotton. Tampons are available in several absorbency ratings. Several countries regulate tampons as medical devices. In the United States, they are considered to be a Class II medi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United States Public Health Service
The United States Public Health Service (USPHS or PHS) is a collection of agencies of the Department of Health and Human Services which manages public health, containing nine out of the department's twelve operating divisions. The assistant secretary for health oversees the PHS. The Public Health Service Commissioned Corps (PHSCC) is the federal uniformed service of the PHS, and is one of the eight uniformed services of the United States. PHS had its origins in the system of marine hospitals that originated in 1798. In 1871, these were consolidated into the Marine Hospital Service, and shortly afterwards the position of Surgeon General and the PHSCC were established. As the system's scope grew to include quarantine authority and research, it was renamed the Public Health Service in 1912. A series of reorganizations in 1966–1973 began a shift where PHS' divisions were promoted into departmental operating agencies. PHS was established as a thin layer of hierarchy above ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Good Manufacturing Practices
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality manageme ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Trials
Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, pharmaceutical drug, drugs, medical nutrition therapy, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received institutional review board, health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. Depending on product type and development stage, investigators initially enroll volunteers or patients into small Pilot experiment, pi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pure Food And Drug Act
The s:Pure Food and Drug Act of 1906, Pure Food and Drug Act of 1906, also known as the Wiley Act and Harvey Washington Wiley, Dr. Wiley's Law, was the first of a series of significant consumer protection laws enacted by the United States Congress, and led to the creation of the Food and Drug Administration (FDA). Its main purpose was to ban foreign and interstate traffic in adulterated or mislabeled food and drug products, and it directed the U.S. Bureau of Chemistry, US Bureau of Chemistry to inspect products and refer offenders to prosecutors. It required that active ingredients be placed on the label of a drug's packaging and that drugs could not fall below purity levels established by the United States Pharmacopeia or the Formulary (pharmacy), National Formulary. In the late 1800s, the quality of food in the US decreased significantly as populations moved to cities and the time from farm to market increased. Many food producers turned to using dangerous preservatives, inc ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Federal Food, Drug, And Cosmetic Act Of 1938
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) 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 introduction of this act was influenced by the death of more than 100 patie ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Microwaves
Microwave is a form of electromagnetic radiation with wavelengths shorter than other radio waves but longer than infrared waves. Its wavelength ranges from about one meter to one millimeter, corresponding to frequencies between 300 MHz and 300 GHz, broadly construed. A more common definition in radio-frequency engineering is the range between 1 and 100 GHz (wavelengths between 30 cm and 3 mm), or between 1 and 3000 GHz (30 cm and 0.1 mm). In all cases, microwaves include the entire super high frequency (SHF) band (3 to 30 GHz, or 10 to 1 cm) at minimum. The boundaries between far infrared, terahertz radiation, microwaves, and ultra-high-frequency (UHF) are fairly arbitrary and differ between different fields of study. The prefix ' in ''microwave'' indicates that microwaves are small (having shorter wavelengths), compared to the radio waves used in prior radio technology. Frequencies in the microwave range are often refer ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pregnancy Tests
A pregnancy test is used to determine whether a person is pregnant or not. The two primary methods are testing for the pregnancy hormone (human chorionic gonadotropin (hCG)) in blood or urine using a pregnancy test kit, and scanning with ultrasonography. Testing blood for hCG results in the earliest detection of pregnancy. Almost all pregnant people will have a positive urine pregnancy test one week after the first day of a missed menstrual period. Types Human chorionic gonadotropin (hCG) Identified in the early 20th century, human chorionic gonadotropin (hCG) is a glycoprotein hormone that rises quickly in the first few weeks of pregnancy, typically reaching a peak at 8- to 10-weeks gestational age. hCG is produced by what will become the placenta. hCG testing can be performed with a blood ( serum) sample (typically done in a medical facility) or with urine (which can be performed in a medical facility or at home). The assays used to detect the presence of hCG in blood ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
COVID-19
Coronavirus disease 2019 (COVID-19) is a contagious disease caused by the coronavirus SARS-CoV-2. In January 2020, the disease spread worldwide, resulting in the COVID-19 pandemic. The symptoms of COVID‑19 can vary but often include fever, fatigue, cough, breathing difficulties, anosmia, loss of smell, and ageusia, loss of taste. Symptoms may begin one to fourteen days incubation period, after exposure to the virus. At least a third of people who are infected asymptomatic, do not develop noticeable symptoms. Of those who develop symptoms noticeable enough to be classified as patients, most (81%) develop mild to moderate symptoms (up to mild pneumonia), while 14% develop severe symptoms (dyspnea, hypoxia (medical), hypoxia, or more than 50% lung involvement on imaging), and 5% develop critical symptoms (respiratory failure, shock (circulatory), shock, or organ dysfunction, multiorgan dysfunction). Older people have a higher risk of developing severe symptoms. Some complicati ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Orthopedic Plates
An orthopedic plate is a form of internal fixation used in orthopaedic surgery to hold fractures in place to allow bone healing and to reduce the possibility of nonunion. Most modern plates include bone screws to help the orthopedic plate stay in place. Historic overview Prior to the invention of the orthopedic plate, metal wiring was used to solve the issue of bone fractures until about 1850. It was debated when the first use of this technique was actually made. Supposedly, the first use of this metal wiring was by the ancient Greeks. The first recorded use of metal wiring was in 1755 in a French journal. It was not until 1870, a Frenchman by the name of Laurent Berenger-Feraud began writing a book on internal fixation and bone fractures called "''"'' (a book on direct immobilization of bone fragments of fractures). All the information proved to be beneficial in medical procedures, however one thing lacked, the antiseptic treatments needed to properly administer these technique ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Hip Replacement
Hip replacement is a surgery, surgical procedure in which the hip joint is replaced by a prosthetic implant (medicine), implant, that is, a hip prosthesis. Hip replacement surgery can be performed as a total replacement or a hemi/semi(half) replacement. Such joint replacement orthopaedic surgery is generally conducted to relieve arthritis pain or in some hip fractures. A total hip replacement (total hip arthroplasty) consists of replacing both the acetabulum and the femoral head while hemiarthroplasty generally only replaces the femoral head. Hip replacement is one of the most common orthopaedic operations, though patient satisfaction varies widely between different techniques and implants. Approximately 58% of total hip replacements are estimated to last 25 years. The average cost of a total hip replacement in 2012 was $40,364 in the United States (€37,307.44 in euros), and about $7,700 to $12,000 in most European countries. NOTE: In euros, that is from €7,116.92 to €11,091 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
