Despite the importance of medical devices for the treatment of human health conditions, the development of new drugs and biological products often receives greater attention than the development of new devices. In fact, less attention is paid to devices for rare diseases and conditions than to drugs and biological products. Moreover, discussions about devices are usually linked to pediatric populations. Here is an overview of the regulatory process for medical devices. Listed below are the main steps in the development of a new medical device.
Classification of medical devices
There are many variables involved in determining a medical device’s classification. The intended use of the device is a key factor in determining its classification. The intended use must match the claims made on the device’s label. If it does not, the device will be deemed to be intended for general medical use. The FDA is currently undergoing a review process to ensure that the classification is appropriate for each device. Until such a review, manufacturers will have to rely on the claims on the device’s label.
The FDA classifies medical devices by their risk to the public and intended users. There are three different levels of risk associated with medical devices: low, intermediate, and high. Low-risk devices include non-electric wheelchairs, bandages, and handheld surgical instruments. Intermediate-risk devices include computed tomography scanners and infusion pumps used for intravenous medications. High-risk devices include pacemakers and deep-brain stimulators.
Regulation of medical devices
The EU has strict requirements on the manufacture, distribution, and use of medical devices. These requirements are derived from the European Community’s New Approach legislation, which covers most consumer goods except pharmaceuticals. The New Approach incorporates self-regulation of the medical device industry while setting a minimum regulatory standard for public health and safety. It also reflects the dynamic nature of the device industry. Nevertheless, it is essential to note that the European Union has not yet regulated all medical devices.
The Regulation of Medical Devices covers both manufacturers and initial distributors of medical devices. The establishment registration form is electronically submitted to the FDA and must be reviewed annually. Manufacturers must designate a U.S. Agent. The registration fee is mandatory for most establishments starting on October 1, 2007.
Clinical trials for medical devices
More medical device companies are turning to clinical trials to improve their products’ chances of being adopted into the marketplace. In particular, these trials help to improve the design of surgical tools and other devices, as well as evaluate their safety and effectiveness. But they can be complex, and some companies opt for placebo studies instead. Below are some tips for conducting a medical device clinical trial. They will help you plan the study and stay within the guidelines.
First, you must determine what kind of trial to run for the medical device. The trial must first be approved by the FDA and then approved by the appropriate regulatory body. Clinical trials are not conducted on healthy people. Rather, a small group of patients is chosen to test the safety, performance, and feasibility of the device. After this initial testing, pivotal trials are run with a larger group of patients. Then, post-approval studies are done to evaluate how long the device is safe and effective, and whether the risks of using the device are understood and avoided.
Postmarket studies for medical devices
Postmarket studies for medical devices are required by law. Manufacturers typically initiate these studies at the request of the FDA, but they should also be integrated into a national post-market surveillance initiative. Of the 26 manufacturers, 22 reported conducting at least one post-market clinical research study, while one manufacturer reported never conducting any. Post-market studies are usually conducted to fulfill FDA requirements, but may also be done for market acceptance or performance monitoring purposes.
As of February 2015, 88 percent of postmarket studies had stopped, were inactive, or had other reasons, such as the device being taken off the market. Eighteen of the studies had been completed and were continuing, but there were many that were still inactive. Most of these studies were delayed due to difficulties enrolling patients, as was the case with the consolidated study of several devices. The FDA attributes the delays to under-enrolled studies, recalled devices, and consolidation of clinical research.
Impact of technological advances on the development of medical devices
Health planning laws have historically regulated the development and adoption of “big ticket” medical devices. These laws were effective in controlling the spread of new technologies, but many devices have been rejected due to a lack of clinical evidence. However, since the introduction of several new devices, these laws have become weaker, and the payment method has become an increasingly important factor in determining device adoption. As a result, it is important to consider the impact of technological advances on the development of medical devices, and how these advancements are affecting the development of these devices.
The pharmaceutical industry is characterized by a high concentration of small firms; almost half of U.S. medical device manufacturers have fewer than 20 employees. In contrast, large companies dominate the market in terms of sales. According to Roberts, small firms often contribute the greatest innovations in developing a new class of medical devices, although larger firms play an important role later in the development process. Some smaller firms will acquire larger firms.