Food and Drug Administration (FDA) Food and Drug Administration

Main article: Healthcare in the United States

The Food and Drug Administration (FDA, USFDA) is an agency of the United States Department of Health and Human Services, one of the federal executive ^[1].

The department is engaged in quality control of food, medicines, cosmetics, tobacco products and some other categories of goods, monitors compliance with legislation and standards in this area.

The FDA is responsible for preserving public health through regulation and oversight of food safety, tobacco products, food additives, drugs (both prescription and over-the-counter), vaccines, medical devices, and veterinary drugs.

2019: Akorn warning of'improper' investigation into causes of poor manufacturing

On July 12, 2019, it became known that the FDA issued a written warning sent to Akorn (Acorn), which detailed cases of improper investigation of the reasons for the release of low-quality batches of drugs, and also indicated that the company lacks data control and does not use aseptic production technologies. Read more Here.

2017: Plans to Regulate the Medical Software Market

In late July 2017 to medicine , the Food and Drug Administration (FDA) unveiled a Digital Health Innovation Action Plan. The agency intends to regulate the market. medicalsoftware

A pilot software pre-certification program was a key part of the plan. This initiative will help the regulator develop an effective approach to controlling technology in the digital health sector, FDA Commissioner Scott Gottlieb said in an official management blog.

FDA Office

Our recommendation pilot program will allow us to form a personalized approach to this technology, focusing primarily on software or digital health technology developers, rather than a product, as is now the case with traditional medical devices. This project will help us establish the most suitable criteria for companies participating in the pre-certification program with these tools, "said Gottlieb.

Companies will be able to submit applications for this program starting August 1, 2017. During this month, a team of IT medicine professionals at the FDA will evaluate candidates and select nine winners.

According to the AuntMinnie.com website, the Digital Health Innovation Action Plan initiative testifies to the FDA's intention to amend the 21st Century Cures Act, signed by former US President Barack Obama at the end of 2016. In particular, the regulator is going to change the policy regarding mobile medical applications and equipment used to transmit, store, display or transform medical information.^[2]

2016: Introduction of cybersecurity standards for medical devices

In late December 2016, the Food and Drug Administration (FDA) approved cybersecurity standards for medical devices that were previously approved by the department and used in hospitals or directly by patients (implantable devices).

According to the 30-page document, medical equipment should be fully protected from all kinds of cyber threats by the manufacturers themselves, who now bear personal responsibility for device software vulnerabilities. Companies must update the software in a timely manner and quickly fix all security holes in the devices.

The Food and Drug Administration has approved cybersecurity standards for medical devices that have previously been approved by the department and are used in hospitals or directly by patients

In addition, data on all detected threats should go to the FDA to assess the scale of the problem. If the severity of the potential harm is high, but the problem has not affected any person, manufacturers must inform customers about the vulnerability within 30 days and find a way to fix it no later than 60 days later.

According to FDA experts, the final version of the recommendations issued corresponds to the realities and dangers of today, recognizing the constant presence and variability of cyber attacks.

Protecting medical devices from ever-changing cyber threats requires a comprehensive approach throughout the product's life cycle, notes Suzanne Schwartz, assistant director of the medical devices division of the Food and Drug Administration.

Commenting on the FDA's introduction of new requirements for cyber protection of medical devices, Medtronic said that the company pays attention to cybersecurity both during the design stage of products and during their use on the market. The challenge is to add security features while maintaining the convenience and ease of use of the devices, Medtronic said.^[3]

2008: Drug trials on Peruvian citizens who cannot read

Since the early South America 2000s, the number of drug trials intended for sale in and has increased sharply in Central USA. Britain

Peru became the leader in the total number of clinical trials (13 thousand official participants in 2008) - while a very unpleasant detail was revealed: the American Food and Drug Administration did not deign to send a single inspector to these trials.

The studies concerned drugs for patients with HIV/AIDS, oncology and diseases of the female genitourinary system. It was later revealed that some trials did not receive any approval from Peruvian health authorities and did not involve fixation of side effects. Moreover, the majority of respondents turned out to be patients of social hospitals and could not even read and write, signing consent to fingerprint trials.

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