What does the food and drug administration do?

By definition, a government agency with operations under the jurisdiction of the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA) regulates food, drugs, cosmetics, biologics, and blood products. The FDA must oversee its regulatory actions in the U.S.

and abroad and consists of the Office of Commissioner and four directorates: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations. The FDA is dedicated to protecting public health through effectiveness and efficiency and the assurance of security.

Focusing on consumer protection, the FDA seeks to provide Americans with the safest food and drug products on the market.

Highlights of FDA History

Food and Drug Administration logo

What Does the Food and Drug Administration Do?

The beginning of the FDA can be traced back to the year 1848, when a chemist named Lewis Caleb Beck was hired By the U.S. Patent Office to conduct research on agricultural products. The work of Beck coupled with findings that American soldiers in the Mexican War were dying from weak drugs propelled Congress to pass the Drug Importation Act. This legislation led to tighter controls on unsafe and adulterated drug imports. Yet, by the start of the Civil War, this law was less effective due to the improper tactics of inspectors whose appointments had been made for political gains.

By the early 1900s, much research and development occurred in the area of biological therapeutics, particularly serum therapy, for the control and eradication of infectious diseases.

On July 1, 1902, Congress enacted the Biological Control Act, which oversaw the licensing of drug manufacturers, interstate commerce, and the supervision of qualified scientists. Due to the corruption of food and drug production and testing, many states passed laws to underscore rampant fraud.

For instance, patent medicine manufacturers had the power to synthesize products made from their chemicals of choice and then advertise in favor of them despite state regulatory laws.

Around this time, Harvey Wiley, the director of the Department of Agriculture's Bureau of Chemistry, fought against the shenanigans of the administration of food and drugs in the U.S.

Wiley focused on protection against exploitation by the food and drug industries and the passage of the 1906 Pure Food and Drug Act, a law to halt the misbranding of drugs and to order the labeling of dangerous substances, such as alcohol, morphine, and heroin.

The 1906 Pure Food and Drug Act, although initially helpful, would be replaced in three decades later by the 1938 Food, Drug, and Cosmetic Act, which was sponsored by President Franklin D. Roosevelt.

Harvey Wiley (in suit) in the Lab

What Does the Food and Drug Administration Do?

It was at this time that the FDA took major shape as the nation's comprehensive consumer protection agency. The agency now required any drug manufacturer to prove the safety and effectiveness of any new drug before it could be put on the market.

Moreover, these drugs required clear directions for use and thorough labels with any warnings. Further, any hard drugs that had to be administered by health professionals were labeled accordingly.

Thus, the FDA had to control the access and distribution of effective, prescription drugs as well as the restriction of illegal drugs from the 1940s to the 1960s.

In the next decades, the FDA redirected its focus on the treatment of orphan or rare diseases.

The organization worked to mobilize pharmaceutical companies that were reluctant in their research and development of drugs for rare disorders.

Providing financial aid, planning incentives, and monopolies to market drugs, the FDA enabled these companies to get more involved with saving the lives of people with rare diseases.

More on the FDA's Purpose

Drug Products

What Does the Food and Drug Administration Do?

Food and Drug Administration

The FDA plays a pivotal role in the lives of Americans.

The agency helps to speed innovations that make medicines and foods more effective, safer and more affordable, and plays a key role in monitoring, preparing for and responding to global public health challenges, such as antibiotic resistance and Ebola.

Overall, the agency oversees a quarter of the products consumers purchase each year.  It is essential to ensure FDA receives the resources needed to fulfill its myriad responsibilities, including ensuring patients can access effective medical advances as quickly and safely as possible.

NOTE: Does not include supplemental funding from the American Recovery and Reinvestment Act of 2009 or the Ebola emergency supplemental funding in 2015.

Sources: FDA Reports, House Committee on Appropriations.

Americans Support Increased Funding for FDA

The Food and Drug Administration (FDA) is the agency responsible for the safety and effectiveness of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics and products that emit radiation. How important is it to increase funding for the FDA?

Source: A Research!America poll of U.S. adults conducted in partnership with Zogby Analytics in January 2016.

The FDA plays a significant role in everyday life in the United States

It oversees 75% of the US food supply.[1] It makes sure anything labeled with SPF offers effective sun protection[2], and that our cosmetics don’t contain unsafe levels of heavy metals.

[3] On top of that, it regulates and ensure the safety of drugs we use, from ibuprofen for our head and stomach aches to life saving medications for rare diseases. American cupboards are filled with goods the FDA regulates.

This far-reaching agency, however, has humble origins: it began as a chemistry laboratory in the Agricultural Division of the U.S. Patent Office.

[4] Its original mission was modest as well; Congress tasked the laboratory staff in 1848 to chemically analyze “vegetable substances produced and used for the food of man and animals in the United States.”[5] By 1930, the year in which the Division was renamed the U.S. Food and Drug Administration, the mission of the agency had changed dramatically.[6]

Until the early 1900s, the American marketplace was virtually unregulated and not all products were what they claimed to be. For example, “honey was diluted with glucose syrup; olive oil was made with cottonseed; and ‘soothing syrups’ given to babies were laced with morphine.

”[7] Certain individuals were concerned about how these products would affect the health of the American people. Harvey Wiley, for example, is often thought of as the first head of the FDA because of his tireless work to promote federal regulation of food and drugs.

In 1902, he organized a group of volunteers known as the “Poison Squad” who tried out dubious products on themselves to demonstrate their negative effects.[7] Besides Wiley, the public was also starting to take an interest.

In 1906 reporter Sinclair Upton published his novel The Jungle, which shed light on the unsanitary conditions of the American meatpacking industry at the time.[8]

The sustained efforts of Harvey Wiley, combined with a heightened public awareness of the importance of food and drug regulation in ensuring public health and safety, culminated in the passage of The Pure Food and Drug Act, also known as the Wiley Act, in 1906. The Act prevents “the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs or medicines, and liquors.”[9] This landmark legislation set the stage for the FDA’s continued role in regulation.[8]

The FDA has made numerous regulatory decisions over time to protect the safety of American food and drugs. Twenty two years after the Pure Food and Drug Act was passed, scientists in London discovered penicillin, which ushered in the new age of antibiotics.[10]

The FDA began to test penicillin’s safety as part of the wartime development program in 1943 and approved the drug in September of that year.[11] As output increased, the FDA was given authority[12] to examine a sample of every batch of penicillin produced before it was released to the public or shipped overseas.

In 1960, FDA worker Frances Oldham Kelsey denied an application to sell thalidomide, originally marketed as a sleeping pill.

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She felt there was inadequate clinical evidence concerning the drug’s potential side effects. Her steadfastness won out, and the FDA limited the distribution of the drug in the U.S.

Thalidomide was eventually linked to birth defects seen in thousands of infants abroad.[13]

What Does the Food and Drug Administration Do?

Fast forward nearly thirty years to the height of the HIV and AIDS epidemic, when the FDA became the first public health agency in the world to approve an HIV drug —AZT.

[14] Patient advocates pushed FDA to reexamine a regulatory paradigm that simply was not nimble enough to respond to the HIV/AIDS threat, and the drug was approved in just four months[15] underscoring the seriousness of the epidemic.

[16] Though not a perfect solution and not prescribed as often today, the drug provided a much needed breakthrough in the seemingly unbreachable spread of the disease at the time.[17]

As the American people, and the world at large, turn to science for solutions to the problems we face, it’s critical that the FDA has the necessary resources to answer the call.

It is simply impossible for patients and providers to determine the safety and effectiveness of each individual medical product that comes on the market and the public relies heavily on the FDA to be a vigilant gatekeeper.

It’s essential that they be able to continue to play that role.

Sources:

[1] https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance   

[2] https://www.fda.gov/drugs/understanding-over-counter-medicines/sunscreen…

[3] https://www.fda.gov/cosmetics/potential-contaminants-cosmetics/fdas-test…

[4] https://www.fda.gov/about-fda/history-fdas-fight-consumer-protection-and…

[5] https://www.fda.gov/about-fda/history-fdas-internal-organization/fda-lea…

[6] https://www.fda.gov/about-fda/history-fdas-fight-consumer-protection-and…

[7] https://www.fda.gov/about-fda/fda-leadership-1907-today/harvey-w-wiley

[8] https://www.fda.gov/about-fda/fdas-evolving-regulatory-powers/part-i-190…

[9] http://library.clerk.house.gov/reference-files/PPL_059_384_FoodDrugCosmeticAct.pdf

[10] https://www.acs.org/content/acs/en/education/whatischemistry/landmarks/f…'s%20Hospital%20in%20London.

[11] https://www.fda.gov/about-fda/virtual-exhibits-fda-history/brief-history…

[12] https://jamanetwork.com/journals/jama/article-abstract/275427

[13] https://www.fda.gov/about-fda/virtual-exhibits-fda-history/frances-oldham-kelsey-medical-reviewer-famous-averting-public-health-tragedy

[14] https://www.niaid.nih.gov/diseases-conditions/antiretroviral-drug-develo…

[15] https://aidsinfo.nih.gov/news/274/approval-of-azt

[16] https://www.pbs.org/wgbh/pages/frontline/aids/interviews/fauci.html

[17] https://www.thelancet.com/action/showPdf?pii=S2352-3018%2817%2930066-8

The Food and Drug Administration (FDA)

What Does the Food and Drug Administration Do?

The Food and Drug Administration (FDA) plays a large role in technology diffusion in the medical field, by:

  • Ensuring the safety and effectiveness of drugs and medical devices
  • Controlling access by deciding which drugs need prescriptions and which ones can be obtained over the counter
  • Legislation requires the FDA to review the safety and effectiveness of a new drugs before being marketed
  • Watch the interview below with John Jenkins, Director of the Office of New Drugs at the Center for Drug Evaluation and Research. Pay particular attention to his comments on quality and safety of approved drugs, including post-approval surveillance.

 What the FDA Does

  • Approve drugs for specific indications, although physicians may prescribe for other uses once drug is available (off-label use)
  • The FDA also regulates foods, drugs, radiation-emitting devices, vaccines and biologics, animal and veterinary products, and cosmetics and tobacco.  
  • The USDA also regulates specific foods such as meat, poultry and eggs.  Foodsafety.gov has comprehensive information on food safety, including recent product recalls.   

The United States is the global leader in medical device innovation and the Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is committed to assuring that American patients have timely access to important new technologies and next-generation products without compromising their safety.

Each year, millions of American patients benefit from innovative medical devices that reduce suffering, treat previously untreatable conditions, extend lives, and improve public health.

CDRH is responsible for advancing public health and facilitating innovation to help bring novel technologies to market and make the medical devices that are already on the market safer and more effective.

What the FDA does NOT do:

  • Fund studies
  • Perform studies
  • Require cost data
  • Evaluate cost effectiveness

For more information visit the U.S. Food and Drug Administration website. 

You can also explore the FDA Drug Approval Process Infographic provided as a Drug Approval Process (PDF). Alternatively, you can view it online.

Food and Drug Administration

One of the oldest U.S. Consumer Protection agencies, the Food and Drug Administration (FDA) protects the public from unsafe foods, drugs, medical devices, cosmetics, and other potential hazards.

As part of the department of health and human services, the FDA annually regulates over $1 trillion worth of products, which account for one-fourth of all consumer spending in the United States.

It also protects the rights and safety of patients in clinical trials of new medical products, monitors the promotional activities of drug and device manufacturers, regulates the labeling of all packaged foods, and monitors the safety of the nation's blood supply.

To ensure compliance with its regulations, the FDA employs over 1,000 investigators and inspectors who visit over 15,000 food-processing, drug-manufacturing, and other facilities each year. If it finds violations of law, the FDA first encourages an offending company to voluntarily correct the problem or to recall a faulty product from the market.

If the firm does not voluntarily comply with the law, the FDA may take it to court and seek criminal penalties against it. The FDA may also seize faulty products, order product recalls, seek injunctive relief, impose fines, and take other types of enforcement action.

Each year, the FDA declares about 3,000 products and 30,000 import shipments to be unacceptable in various ways.

The FDA employs over 2,000 scientists—including 900 chemists and 300 microbiologists—who provide the Scientific Evidence to back up its regulatory and inspection duties.

These scientists analyze samples of products for purity and review test results of new products. The FDA itself does not do research for a new medical product.

Instead, it evaluates the results of studies undertaken by the manufacturer.

History

Food production in the United States has been regulated since the late eighteenth century. Colonies and, later, states passed laws banning impurities from selected foods.

In 1848, the United States began regulating imported drugs, under the Drug Importation Act (Ch. LXX, 9 Stat. 237). The enforcement of food and drug laws was first assigned to the Chemical Division of the new u.s.

department of agriculture (USDA) in 1862 (12 Stat. 387).

The need for laws to regulate food and drug purity became increasingly urgent in the late nineteenth century, when substances such as opium, cocaine, and heroin were commonly added to medicinal elixirs and tonics.

The need for government regulation was also made evident in Upton Sinclair's book, The Jungle, which exposed the unsanitary conditions of Chicago's meatpacking industry and shocked the nation.

On June 30, 1906, Congress, with the support of President Theodore Roosevelt, passed two landmark pieces of Progressive Era legislation that strengthened the government's ability to protect consumers: the Food and Drug Act (34 Stat. 768 [21 U.S.C.A. § 1–15]) and the Meat Inspection Act (21 U.S.C.A. § 601 et seq.).

The former prohibited interstate commerce in misbranded and adulterated foods, drinks, and drugs, and the latter addressed the unsanitary conditions and use of poisonous preservatives and dyes in the meatpacking industry.

In 1927, Congress authorized the creation of the Food, Drug, and Insecticide Administration within the U.S. Department of Agriculture. In 1930, the agency's name was changed to the current one, Food and Drug Administration (Agriculture Appropriation Act, 46 Stat. 976).

In 1937, 107 people died after taking the elixir sulfanilamide, a supposedly healing tonic. This tragedy prompted the passage of the next major reform of food and drug law, the Federal Food, Drug, and Cosmetic Act of 1938 (21U.S.C.A. § 301 et seq.).

The FDA was then entrusted with the regulation of cosmetics and therapeutic devices and was authorized to do factory inspections. Even more importantly, the act required new drugs to be tested on animals and humans for safety before being marketed.

In 1957, the Food Additives Amendment (Pub. L. 85-250, Aug. 31, 1957, Stat. 567) required the evaluation of food additives to establish safety, and in the following year, the Delaney Clause (Pub. L. 85-929, Sept. 6, 1958, 72 Stat.

1784) forbade the use in food of substances found to cause cancer in laboratory animals.

How the FDA Approves New Drugs

The process by which the Food and Drug Administration (FDA) approves drugs as safe and effective is generally long and complicated, though it may vary according to the type of drug and the nature of the illness for which it is being developed. The FDA refers to drugs under development as investigational new drugs, or INDs.

The evaluation of new drugs requires the skills of many different FDA scientists and professionals performing a wide variety of tasks. Biochemists and molecular biologists evaluate the basic chemistry and biology of new chemical compounds and molecular structures.

Toxicologists assess the potential harm of proposed drugs, and pharmacologists study how these drugs affect the body and are broken down and absorbed by it. Computer scientists create electronic models that aid in the understanding of new chemicals.

Physicians evaluate the results of clinical trials, assessing both the beneficial and adverse effects of the drugs. And statisticians evaluate the design and results of controlled studies.

It is an expensive and time consuming process, particularly for the company developing the drug, called a drug sponsor. A sponsor spends an average of $359 million for each new drug brought to market.

Typically, the process takes eight and a half years and may be divided into roughly three stages: preclinical trials, involving animal and other laboratory tests (lasting one and a half years on average); clinical trials, involving tests on humans (five years); and FDA review (two years).

Preclinical Trials Once a sponsor has developed a drug, it must test the drug on animals in the laboratory. In doing so, the drug sponsor must follow FDA guidelines and regulations.

These tests, also called preclinical trials, are usually done on more than one species of animals.

FDA guidelines call for the inspection of animal laboratories every two years to ensure that they are being operated according to the administration's regulations.

After short-term lab testing has been performed and the sponsor has deemed its results adequate, the sponsor submits test data and plans for future clinical trials to the FDA.

FDA scientists, together with a local institutional review board composed of scientists, ethicists, and nonscientists, then conduct a thirty-day safety review to decide whether to allow testing on humans.

The vast majority of new drugs tested in the laboratory are rejected by either the sponsor or the FDA because they are unsafe or ineffective.

If the FDA indicates approval, the drug sponsor may begin clinical testing on humans. Even if a drug is approved for clinical trials, the sponsor continues animal testing of the drug in order to better understand the drug's long-term effects.

Clinical Trials

Where Did the FDA Come From, And What Does It Do?

In the past month, the Trump administration has already started to reshape the alphabet soup of federal agencies that regulate Americans’ food, air and water.

Most of the spotlight has been on the Environmental Protection Agency, which underwent a hearing this week titled “Make EPA Great Again” that laid out a controversial bill seeking to limit the scientific data the agency can use to create regulations.

 But there are plenty of other science-focused agencies that regulate issues critical to Americans’ health and well-being.

As fundamental changes come to some of these agencies, it’s worth looking back at how they originated and what they actually do.

We’ll start with the Food and Drug Administration, which exists to ensure the safety of America's food, cosmetics, drugs and medical devices.

For most Americans, the phrase “FDA approved” serves a seal of trust: It means that the product in your hands—whether it’s a tube of lipstick, an insulin pump or a condom—has been deemed scientifically, medically and nutritionally sound. But who’s doing all that vetting?

What it does

Overall, the FDA estimates that it regulates roughly $1 trillion worth of products annually. These include consumer products that emit radiation, such as microwaves and sunlamps, and even tobacco products and pet and livestock food and medicines. 

The FDA conducts this regulation through the rules it issues, and employs more than 14,000 people to inspect food and drug production and conduct research into new technologies for inspection. (Meat, poultry and eggs fall under the jurisdiction of the Department of Agriculture, while tap water falls under the purview of the EPA.)

How it came to be

The FDA got its start with the passage of the country’s first major food and drug safety bill, the 1906 Pure Food and Drug Act. That law's origins stem from a decades-long fight for the government to regulate food.

Food and Drug Administration

Управление по контролю качества пищевых продуктов и лекарственных препаратовсокращённо — FDA

  • Food and Drug Administration

Общая информация

Страна

  •  США

Юрисдикция

США

Дата создания

1906[1]

Предшественники

Food, Drug, and Insecticide Administration (July 1927 – July 1930)Bureau of Chemistry, USDA (July 1901 – July 1927)Division of Chemistry, USDA (основано в 1862)

Руководство

Вышестоящее ведомство

Министерство здравоохранения и социальных служб США

Руководитель

Скотт Готтлиб[en]

Устройство

Штаб-квартира

White Oak, Maryland[2]

Число сотрудников

14 824 (2010)

Годовой бюджет

4,36 млрд долларов (2012)

Сайт

fda.gov
 Медиафайлы на Викискладе

Управление по санитарному надзору за качеством пищевых продуктов и медикаментов[3] (англ. Food and Drug Administration, FDA, USFDA, букв. “Управление еды и лекарств”) — агентство Министерства здравоохранения и социальных служб США, один из федеральных исполнительных департаментов. Управление занимается контролем качества пищевых продуктов, лекарственных препаратов, косметических средств, табачных изделий и некоторых других категорий товаров, а также осуществляет контроль за соблюдением законодательства и стандартов в этой области.

Скотт Готтлиб, руководитель Управления с 2017 года

Управление было создано в 1906 году в соответствии с Законом о пищевых продуктах и лекарствах[en], вначале называлось Bureau of Chemistry. Под настоящим названием работает с 1931 года.

Глава FDA[en] предлагается президентом США и утверждается сенатом. Он подчиняется министру здравоохранения и социальных служб США.

Функции

FDA отвечает за сохранение здоровья населения путём регулирования и надзора в области безопасности пищевых продуктов, табачных изделий, пищевых добавок, лекарств (как рецептурных так и безрецептурных), вакцин, медицинских устройств и ветеринарных препаратов.

Также FDA контролирует исполнение некоторых законов, например, раздела 361 Закона об общественном здравоохранении[en] и связанных с ними подзаконных актов.

В задачи агентства входит контроль за соблюдением законодательных норм в области поддержания качества продуктов питания, лекарственных препаратов и косметических средств.

Структура

Подчиненные FDA агентства:

  • Center for Biologics Evaluation and Research;
  • Center for Devices and Radiological Health;
  • Center for Drug Evaluation and Research;
  • Center for Food Safety and Applied Nutrition;
  • Center for Tobacco Products;
  • Center for Veterinary Medicine;
  • National Center for Toxicological Research;
  • Office of Criminal Investigations;
  • Office of Regulatory Affairs.

Критика

  • 143 Sudden Deaths Did Not Stop Approval // LATimes, 2000-12-20 (англ.)
  • Statement of Larry D. Sasich, Pharm. D, M.P.H. And Sidney M. Wolfe, MD of Public Citizen’s Health Research Group on the Withdrawal of the Calcium Channel Blocker Mibefradil (Posicor) From the Market. (1998). Public Citizen, 1,2.

Примечания

  1. ↑ FDA Centennial 1906–2006 (неопр.). US FDA. Дата обращения 13 сентября 2008. Архивировано 6 августа 2012 года.
  2. ↑ White Oak Campus Information (неопр.). About FDA. U.S.

    Food and Drug Administration (9 февраля 2011). Дата обращения 11 августа 2011. Архивировано 6 августа 2012 года.

  3. ↑ Food and Drug Administration // Англо-русский экономический словарь (рус.).

    в Англо-русском экономическом словаре // Словари и энциклопедии на Академике.

Ссылки

  • Медиафайлы на Викискладе
  • Официальный сайт FDA (англ.)
  • About FDA. History // U.S. Food and Drug Administration. (англ.)
  • Ежегодные отчёты FDA о новых одобренных препаратах  (англ.)
  • А.П. Мешковский, Роль FDA в регулировании сбыта лекарств в США: маркировка и продвижение фармацевтических препаратов // Фарматека, №4 2001
  • Ежегодно в США пищевые инфекции убивают около трёх тысяч человек
В другом языковом разделе есть более полная статья Food and Drug Administration (англ.).Вы можете помочь проекту, расширив текущую статью с помощью перевода. При этом, для соблюдения правил атрибуции, следует установить шаблон {{переведённая статья}} на страницу обсуждения, либо указать ссылку на статью-источник в комментарии к правке.

About the FDA

The Food and Drug Administration (FDA) is a federal agency within the U.S. Department of Health and Human Services.

The FDA has broad regulatory authority over not just food and drugs, but also biologics such as vaccines, medical devices, tobacco products, certain cosmetics, and some veterinary products.

The agency was formed in 1906 and today employs more than 14,000 people with an annual budget in excess of $4 billion.

1. What Does the FDA Do?

The Food and Drug Administration is responsible for ensuring that food, drugs, and certain other products and processes are safe for consumers.

Most people know that the FDA evaluates drugs and medical devices before they may be offered for sale, but the agency also plays an important role in establishing standards for usage and for distribution of information and labeling. Further, the FDA issues recalls when necessary.

Many people assume that the FDA is responsible for testing drugs, but this is not a role of the agency. Instead, the FDA approval process relies largely on submitted evidence.

2. What is the FDA Drug Approval Process

After a drug developer has conducted laboratory testing (including animal testing) for its new drug, they submit an Investigational New Drug (IND) application to the Food and Drug Administration. This step of the approval process clears the way for human clinical trials.  

Clinical trials take place in three phases, which may take several years to complete. The trials can be halted at any stage, and sponsors meet with the FDA at intervals during the trials. 

Once the trials are completed, the drug sponsor submits a New Drug Application (NDA), and the Food and Drug Administration assesses whether all necessary information has been included.

If the application is found to be complete, the FDA begins review of the clinical data and other information submitted. From this point, the goal is to complete the review within 10 months for most drugs.

High-priority drugs may be tracked for quicker review, and an abbreviated application process is available for generic versions of approved drugs.

3. How does the FDA Regulate Approved Drugs?

What is FDA (U.S. Food and Drug Administration)? – Definition from WhatIs.com

(HHS) that oversees the manufacturing and distribution of food, pharmaceuticals, medical devices, tobacco and other consumer products and veterinary medicine.

The FDA also oversees the development of biological products such as vaccines, products that treat allergies and cosmetics. FDA regulations govern medical devices, food safety, dietary supplements and cosmetics with the intent of ensuring those products are accurately labeled and safe to use. The FDA issues recalls for food and other products that are potentially unsafe.

Guides to the FDA approval processes and guidelines for medical and radiological devices are available on the agency's website.

The FDA defines itself as the country's oldest consumer protection agency. It traces its origins to the U.S. Patent and Trademark Office in 1848 and the creation of the U.S.

Department of Agriculture in 1862, which carried on the Patent Office's duties during chemical analyses of agricultural products.

The FDA's regulatory functions started with the 1906 passing of the Pure Food and Drug Act.

As it relates to the healthcare industry, one of the FDA's main goals is to protect the American public from radiation produced by electronic medical and consumer devices.

All products that give off radiation, such as lasers, X-ray systems and ultrasound equipment, must be preapproved by the FDA's Center for Devices and Radiological Health (CDRH) before they can go to market.

 After the CDRH recognizes that a product was safely manufactured, state agencies supervise the use of that product within their jurisdictions.

The FDA sorts medical devices into three categories according to the stringency of regulation and risk associated with it. Class I is comprised of low-risk devices, such as many health and wellness wearables, manual wheelchairs and toothbrushes. The FDA approval process is not applied to 95% of Class I products.

The CDRH has labeled wearable wellness devices used for general health purposes — such as losing weight, maintaining physical fitness and measuring sleep — that present minimal risk to users' safety as Class I. The CDRH does not plan to impose sanctions on the misuse of any of these products, as they are not intended to treat a specific condition or disease.

Wellness devices include products primarily for fitness tracking, such as Fitbit and Samsung Gear. The Pebble Smartwatch, Apple Watch, Withings Activité and other smartwatches also fall under the wellness device category. The CDRH has also said it generally does not regulate mobile health, or mHealth, apps, but has reserved the discretion to do so if it deems it necessary.

Class II devices are defined as moderate- to high-risk items.

In healthcare, these devices include cardiac output monitors, wearable body monitoring devices that quantify physical movement for medical purposes, anesthesia kits and infusion pumps that have increasingly become connected to hospital computer networks.

FDA regulations require most Class II devices to go through a 510(k) premarket notification approval process in which the manufacturer demonstrates how the device is at least as safe and effective as a legally marketed device.

Manufacturers of Class III devices are required to submit a premarket approval application for the device. Devices in this class are products or medical equipment that preserve or improve patients' health. Only 10% of all medical devices fall into this category, including replacement heart valves, breast implants and pacemakers.

The FDA has often weighed in on health IT matters, such as wearable wellness devices, by publishing nonbinding, but influential, guidance.

For example, a February 2016 report, “Postmarked Management of Cybersecurity in Medical Devices,” urges manufacturers to improve the cybersecurity of their devices and recommends that vendors work with a voluntary cybersecurity framework developed by the National Institute for Standards and Technology (NIST).

Thus far, the FDA has mostly stayed away from regulating the use of health IT products.

In 2014, two years after downgrading medical device data systems from Class III to Class I, the agency released a draft report that freed mobile health application vendors from registering their apps with the FDA and reporting product malfunctions.

The FDA proposed this regulation reduction in the hopes that vendors would have more time to focus on improving the interoperability of their products with different healthcare systems, such as electronic health records or clinical decision support systems.

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