How many centers does the FDA have

How the FDA influences innovation in the healthcare industry

The FDA, the Food and Drug Administration, is the authority in the United States that reviews new drugs and health products and then allows or bans them. It is not only in the USA as the gatekeeper for all new innovations in the health sector. Because what was approved in the USA is also easier on the European market.

In recent years, the FDA has tried to speed up its processing processes through various projects.

The Pre-Cert Program

Some of these changes relate specifically to current trends in the healthcare industry, such as the use of software for healthcare. With its Pre-Cert program, the FDA examines companies instead of individual products, making work easier for itself and others.

The idea is that companies and the FDA can save the time for individual, small-step tests. For example, branches of the large producers Apple or Johnson & Johnson can be certified by the FDA and labeled as trustworthy companies.

Overall, the FDA gives up control over the individual products, but imposes significantly stricter guidelines on the companies for their development.

A new center for digital health

The FDA is also planning to open a digital health center. Modern approaches to regulating the industry are to be developed under the name Center for Excellence for Digital Health.

This could greatly increase the FDA's capacities because it could also accept third parties as certificate issuers.

For health products, this means that more innovation should be possible because there are different contact persons - some experts in digital health, for example.

New rules for genomics

There are some companies that focus on genomics, so the FDA's reach should expand into this area as well.

In June, the FDA passed a simplifying rule that allows tests for individual genetic risks to be marketed without approval. There is only one short, shortened test before the first release.

However, the FDA retains the ability to penalize false claims.

Adjusting the guidelines

The FDA has also recently adjusted its guidelines - which has led to very heated discussions in some cases. One criterion in the assessment of the risks of a tool to support clinical decision-making appears particularly questionable. Instead of the risk, human involvement is the decisive criterion: If a doctor can understand how the tool came to its result, it is a pure aid that is not regulated.

This could lead to difficulties from two different camps: On the one hand, the FDA has given up further control - especially of tools that may make incomprehensible decisions, but represent them in detail. (Just because a book prints a mathematical proof in detail doesn't mean that every reader can understand the proof.)

On the other hand, the regulatory power of the FDA has no clear limits. They can also extend their controls to software that falls into areas other than the core regulation of health issues. In addition, the requirements are enormous when they are thought through to the end: A program that makes a decision based on a complex neural network cannot give any other “reason” for its decision than the entire network. Nevertheless, it can deliver much better results than any other program that makes wrong decisions based on very simple, understandable rules.

The FDA and Europe

The FDA has influence on Europe from two major directions:

On the one hand, of course, the approval of drugs or new devices in Europe also depends on their acceptance in America. Skeptics often see lax regulations in America. But this also means that a product that could not be sold “even in America” will certainly not gain a foothold in strict Europe.

In addition, the FDA pre-filters many innovations. America is a huge country with proportionally many drivers of innovation. If these fail at the FDA, they often do not even try their hand at the European market. And prefer to manufacture their next product based on the rules of the FDA.