The Process for United States FDA. Approval for Medical Drugs and Devices
The regulation of the development and distribution of medical drugs and devices involves two competing interests: ensuring that the medications or medical devices are both safe and effective, while at the same time trying to get the innovative device or drug into the hands of consumers as soon as possible through the investigative processes put in place by powerful regulatory bodies.
This responsibility falls globally to the Federal Food and Drug Administration (FDA) in the United States, and to regulatory bodies in the European Union. In the Czech Republic and European Union it is often described as easier to seek approval for a drug or device. United States approval has key differences, however.
FDA-regulated products are subject to inspection when offered for import into the United States. Products can be refused entry if they appear, from examination or otherwise, to violate FDA requirements. This means that a potential medical or device must go through the FDA approval process before allowed entry into the United States.
Medical Drug Approval
The Pre-Clinical phase is required and is the drug sponsor’s discovery and screening period. In this period, the drug compound is developer and also must be tested on animals for toxicity. Multiple species are used to gather basic information on the safety and efficacy of the compound being investigated/researched. After this, the FDA approval process for new drugs starts with an IND (Investigational New Drug) application which is the means by which a pharmaceutical company can obtain permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. This application is similar to process followed in the EU. After clinical trials are complete, the company must submit an NDA.
An NDA is a New Drug Application and is where the United States streamlines the approval process. In the EU there are four pathways to drug approval, however, in the U. S there is only one. The goal of the NDA is to tell the drug’s whole story, including what happened during the clinical tests, what the ingredients of the drug are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged. The average time for a new medical drug to be approved is 12 years, start to finish, however a lot of this time can be cut if you have already done human clinical trials in the EU, as in the majority of cases these trial results are transferrable.
Medical Device Approval
Medical devices follows a simple to follow process where the FDA assigns devices to 3 main regulatory classes: Class I, Class II, and Class III, in order of low to high risk. The FDA requires a Class I device to have just a Premarket Notification without clinical trials. Class II devices in the United States all require some form of clinical trials to demonstrate that they perform adaquately and safely. Most devices use materials (such as stainless steel or ceramic) that the FDA knows are biocompatible. In these cases, no animal testing is required. However, some devices with new materials require biocompatibility testing in animals.
Class III devices require clinical trials and/or other evidence, but if they are similar to an already approved Class III device, they can forgo clinical testing entirely. This is called the 510 (k) approval process. A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective. The 510 (k) is substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA).
The level of evidence required is often less rigorous than that for new drug approval. The FDA approval process for medical devices is centralized but allows for approval based off of clinical trials or predicate devices. The average time a medical-device approval takes is 3-7 years. The time period for the approval varies as different Class devices and devices with predicates are streamlined easier than others.
For Czech Republic-based or other international companies interested in establishing a presence in the United States, Rutland and partners has the experience and means to assist in all stages of the FDA approval process.
