Medical devices that are used for the diagnosis, treatment and prevention of diseases or conditions, are regulated by the United States Food and Drug Administration (FDA). This usually involves FDA approval / clearance for market launch of the medical device, the design and maintenance of a quality and safety reporting system and facility registration / listing.
FDA’s medical device approval or clearance decision depends on FDA’s benefit risk assessment of the device. Various factors are considered, including;
• The medical necessity of the medical device,
• The type, magnitude and duration of its benefits,
• The medical device’s risks, uncertainties and risk mitigation controls,
• Patient and user preferences.
More and more manufacturers are offering patients innovative medical devices based upon technologies or technologies that are new to medical care. FDA has stepped up to provide regulatory oversight and guidance for these innovative technologies and to facilitate medical device market access. It does so in two ways: by regulating innovative technologies and through facilitating market access.
Concerning regulating devices, mobile medical apps for smartphones and tablets, and wireless medical devices like glucose meters and wearables are at the forefront of what the FDA is regulating. FDA has stepped up to regulate certain mobile apps used in medical care. Mobile apps control the function, operation or energy source of medical devices, such as cochlear implants, infusion pumps, CT or X-Ray machines. These are mobile medical applications (MMA) and are subject to all the regulatory compliance activities identified in the first paragraph above including FDA approval for market launch.
Mobile apps that may be MMAs and are of lower risk are subject to FDA’s enforcement discretion and therefore should comply with FDA’s quality system regulation. Examples include mobile apps that support patient adherence to medications or use gaming technology for physical therapy. Manufacturers of mobile apps in health care must therefore first consult with a regulatory professional to determine whether their mobile app is a medical mobile app and then to determine the regulatory compliance activities appropriate for their MMA or medical device.
As medical devices use wireless technology, FDA has made recommendations with respect to the
selection, quality of service (QoS), coexistence, security and electromagnetic compatibility (EMC) of the wireless technology. Packet loss, signal to noise ratio, bit error rate are useful parameters for assessing wireless data integrity and transmission. For quality assurance and control, wireless technology and cybersecurity should be considered when designing a manufacturer’s quality system. FDA also recommends that manufacturers address cybersecurity of networked medical devices containing off-the-shelf (OTS) software.
Medical devices are often interconnected via an electronic data interface and so FDA is tackling the interoperability of medical devices to ensure their safety and effectiveness. FDA recommends that a manufacturer’s quality system design and medical device design consider the electronic data interface’s purpose, anticipated users of the medical device(s), risk management, verification & validation and labeling.
Facilitate market access
Facilitating market access is done in several ways: by Expedited Access Pathway (EAP) Programs, through Patient Preference Information (PPI) and by Leveraging Clinical Strategies, D’Souza says. For example, devices for the diagnosis or treatment of life threatening or irreversible debilitating conditions or diseases usually require premarket approval (PMA) or de novo regulatory applications for FDA clearance. Manufacturers of such devices may opt for expedited market access if their devices have no legally marketed alternative, or where an alternative exists, the device is in the best interest of patients, has a clinically meaningful, significant advantage over the legally marketed device and is of a breakthrough technology.
Sometimes there is no clear superior treatment option among a series of multiple therapies, evidence for any one therapeutic option may be inconclusive. Patients may differ in views on significant benefits and acceptable risks from health care professionals. In the past, FDA has found that information on patient preferences has facilitated market access and so, in 2015, established a Patient Engagement Advisory Committee (PEAC) for engagement with patients. Medical device manufacturers filing premarket approval applications (PMA), humanitarian device exemption (HDE) applications or de novo requests with FDA can now leverage the use of patient preference information (PPI) in their regulatory submission for market approval.
Medical devices subject to premarket approval applications (PMA), humanitarian device exemption (HDE) applications or de novo requests also may be able to potentially extrapolate adult clinical data to the pediatric population. Additionally, electronic health record (EHR) data may be considered in clinical investigations provided that EHR data validity, reliability and integrity can be verified through inspection by FDA.
FDA is keenly monitoring the evolution of medical device technologies, D’Souza concludes. Medical device manufacturers need to leverage regulatory intelligence, such as has been presented here, for expedited market access and avoid costly delays for regulatory compliance. This goal is attainable if medical device manufacturers and regulatory professionals work together, ideally from the earliest phases of device design, to design a viable strategic plan or path to market that is amenable to changing business objectives, budget constraints and regulatory compliance expectations.