An Overview of FDA De Novo

1. An Overview of FDA De Novo What is FDA? FDA or Food and drug administration is a federal agency Of the United States of America corresponding to its Department of Health and Human Services. The FDA aims at protecting and promoting public health by supervising and monitoring food safety, healthcare products, pharmaceutical drugs, dietary supplements, tobacco products, etc. They focus mainly on implementing and maintaining the Federal Food, Drug, and Cosmetic Act alongside regulating other aspects of the system. The institution has its head office at White Oak, Maryland. What is a De Novo device? The FDA has often been criticized for its failure to allow or approve ground-breaking medical devices encouragingly. The 21st Century Cures Act of 2016 was applauded as it tried to propose solutions to manage these problems offering accessible pathways of

2. regulation. But the federal agency's recent guidelines can hinder competition by allowing the opportunities for adapting an anticompetitive patent system or strategy. The marketers or manufacturers of DE Novo medical devices can utilize the situation to develop patent infringement litigation. The FDA De Novo devices are referred to as the devices for which customary and special controls are capable of providing a reasonable assurance of the efficiency and effectiveness of the device, alongside ensuring its safety. However, legally or formally, there exist no marketed devices of this type. The controls are an essential requirement for ensuring accurate and appropriate safety and efficiency in the real-world market. In the case of the special controls, which are subject to De novo devices' nature (like performance standards, power consumptions, etc.), it also plays a unique role in maintaining a stable and smooth operation of the devices safely. However, the De novo devices' special controls can pose problems because, without extensive testing in the field, the security and efficiency of the machine cannot be adequately measured or be known. Also, the De novo devices

3. being newly manufactured device types contain no historical data to compare to. Thus, appropriate regulation and prediction of these devices become tough. To solve this problem, the FDA has proposed some guidelines following which the De novo applicants must adequately explain their device's safety and why it is deemed safe and efficient. The explanations should be on terms with reason and assurance and are required to be explained considering various factors like technology, usability, stability, longevity, design, materials used, etc. Failure to adeptly and satisfactorily explain such deems the device insufficient and is deemed not ready to be marketed.