Clinical trials of medical devices For medical devices, the sequence is quite similar, with some devices going through a clinical trial phase process; however, most medical devices go through clinical trial "stages" rather than phases. For context, 47 per cent of medical devices fall into this category, and 95 per cent are exempt from regulatory testing. Medical writers preparing CSRs for products such as in vitro diagnostics (IVDs), which fall under FDA device regulations, quickly encounter challenges when using the ICH E3 guidance as the template for an IVD CSR. Clinical testing of medical devices is often critical not only to demonstrate the safety and efficacy of the device, but also to inform clinicians and patients about the preferred use of the device in the marketed clinical setting.
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. Like drugs, medical devices must go through a testing process before they are approved for patients. One obstacle specifically related to the medical device industry is that there is a lack of a common understanding of the concept of outcomes. While approximately 10-15 e of successful 510(k) submissions for Class II devices are based on clinical trial data, Class III devices, the highest risk category, will require extensive clinical trials of medical devices to establish reasonable certainty of safety and efficacy for the end user.
To obtain CE marking, a class III medical device must only demonstrate safety and performance, not necessarily efficacy. Class II devices present a higher risk than Class I devices and are considered to be of 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 510(k) clearance before devices can be marketed in the United States. Before a clinical trial can begin, medical device companies must apply for and obtain an Individual Device Exemption (IDE) from the FDA. Recently, regulatory agencies have emphasised that medical device companies look for creative methods to blind individuals in their trials; if they choose to incorporate a novel technique, they must ensure that the blinding process itself does not introduce bias by impairing the ability to accurately assess the outcome.
In case blinding is not used, medical device companies and their clinical trial partner have to give reasons for not blinding, and discuss limitations in reporting results. Despite the official position that the same guidelines apply to CSRs for medicines and medical devices, a medical writer preparing a CSR for a medical device trial quickly encounters several questions. Medium- and high-risk medical devices, such as implantable medical devices or in vitro diagnostic devices). Being familiar with the specifications and format of clinical trials for drugs and medical devices can help all participants (including medical professionals, clinical staff and patients) to ensure that trials run as smoothly and efficiently as possible.
Greenlight Guru's eQMS software is an ideal solution for medical device companies looking to maximise their clinical trial readiness.