The table below compares the phases of pharmaceutical trials with those of medical devices. Major medical breakthroughs could not happen without the generosity of clinical trial participants, both young and old. One of the main challenges for medical device companies is finding a CRO with the right experience and expertise for their trial. Class II devices are higher risk than Class I devices and are considered moderate risk to the patient: they are subject to special FDA controls and medical device companies must submit a 510(k) premarket notification and obtain clearance before they can market the devices in the US.
Learn why if you fail to properly document design controls, you will end up paying for it later with more medical device claims. While device trials have some basic similarities to drug trials, they have many different requirements and a common assumption for some CROs is that if they have participated in a drug trial in the past they will be able to take responsibility for a medical device trial. These stages vary widely and this is where CROs without medical device trial experience may have some difficulties. In this free guide, you will learn how to start using FDA design controls to your advantage today and implement a process to truly improve your medical device product development efforts.
Before a clinical trial can begin, medical device companies must apply for and obtain an Individual Device Exemption (IDE) from the FDA. For medical devices, the sequence is quite similar, and some devices go through a clinical trial phase process; however, most medical devices will go through clinical trial "stages", rather than phases. Before a medical device company can begin conducting clinical trials of medical devices, it must determine the types of trials best suited to establish the safety and efficacy of the product. With regulators, payers and physicians demanding more data and even patients demanding to see clinical trials, medical device companies and CROs are beginning to have to match biopharmaceutical companies in the number of trials being conducted.
When you think of medical devices, complex instruments such as a hip replacement or a surgical robot may come to mind. One of the main challenges for CROs that have worked in drug trials and want to move into the growing medical device sector is their own lack of experience with similar devices. When the US FDA approves an IDE application, it may allow the medical device company to conduct a feasibility study or a pivotal study.