• Interventional Techniques & Devices

• Cardiology & Cardiovascular Medicine
• Interventional Techniques & Devices

The Center for Devices and Radiological Health (CDRH) of the United States Food and Drug Administration (US FDA) has undertaken work to refine its direction towards smart regulation, to protect public health by ensuring safe devices, and to promote public health by facilitating device innovation, according to Christy Foreman, Director of the Office of Device Evaluation at CDRH. She reviewed the updated mission, vision, and strategic plan for the CDRH, and its impact on regulatory science, clinical trials, feasibility trials, and pre- and postmarketing data.

In particular, the CDRH strives to ensure that patients in the US have access to high-quality, safe, and effective medical devices that will be available in a timely fashion. In accordance with this mission and vision, six strategic priorities have been developed to achieve the CDRH goal:

• ▪ Patients in the US have early access to high-quality, safe, and effective medical devices of public health importance

• ▪ The US is the world's leader in regulatory science, medical device innovation and manufacturing, and radiation-emitting product safety

• ▪ US postmarket surveillance quickly identifies poorly performing devices, accurately characterizes real-world performance, and facilitates device approval or clearance

• ▪ Devices are legally marketed in the US and remain safe, effective, and of high-quality

• ▪ Consumers, patients, their caregivers, and providers have access to understandable science-based information about medical devices and use this information to make healthcare decisions

• ▪ Strengthen the CDRH workforce and workplace

To achieve its priority regarding regulatory science, the CDRH has identified the need to improve the computer modeling used in order to augment bench, animal, and clinical testing for device development, because a single model alone cannot demonstrate safety and effectiveness.

The CDRH has planned changes to enhance the process for first-in-human and early feasibility trials to promote the more timely initiation of clinical studies in the US. This is to improve patient access to new devices by encouraging innovation to address clinical needs and improve patient care, particularly when alternative treatments are unavailable, ineffective, or they are associated with significant risk. The goal of these changes is to reduce the time from bench testing to initial clinical studies, and accelerate the implementation of changes to the product or study design after a study is initiated, while maintaining protection of human subjects. Foreman noted that the approval of an early feasibility study, including some first-in-human studies, may be based on less nonclinical data than for other types of studies, such as traditional feasibility or pivotal studies. To this end, a benefit-risk assessment to consider the appropriate level of evidence needed to initiate a clinical study will be conducted, and consideration given to patient perspectives on benefits and risk tolerance as well as risk mitigation strategies.

The CDRH has planned changes to strengthen and streamline the clinical trial enterprise, so that medical device clinical trials can be conducted in a safe, efficient, least burdensome, and cost-effective manner, stated Ms. Foreman. A framework is being developed for appropriate, timely, and efficient decisions for investigational device exemptions (IDE) that is tailored to the type of study and to the benefit-risk decision-making. The CDRH is developing guidance regarding the benefit-risk determinations for the IDE decision process, which will be based on the type of study, such as early or traditional feasibility study or pivotal study. It will also establish metrics to assess the progress of the CDRH in this process of improving the clinical trial enterprise.

The CDRH is evaluating the right balance for the data that are needed pre- and postmarket. One consideration in this regard is whether a decision can be made about the safety and effectiveness of a device with potentially less data or follow-up if there is a prospective plan to collect postmarket data. Another consideration is whether premarket data requirements can be adjusted for mature technology with significant real-world experience.

Device registries are an effective mechanism for postapproval studies. Benefits of registries include the ability to obtain data on short- and long-term outcomes of devices and procedures, and the ability to provide information about clinical safety and effectiveness after devices are on the market. For example, a labeling change for a transcatheter heart valve was made based on data from the TVT registry. Also, postapproval studies can lead to expanded indications, which was the case for drug-eluting stents and for endograft treatment of complicated type B aortic dissection. The MitraClip Post-Approval Study will use registries for data collection.

A system of unique device identifiers (UDI), a numeric or alphanumeric code assigned to a specific medical device, has been established by the FDA for all medical devices in the US. Ms. Foreman stated the UDI system would provide more reliable data on how medical devices are used, provide the capacity for nearly real-time data collection, and represents a step towards modernizing postmarketing surveillance by the CDRH. Furthermore, the UDIs may prove to be very powerful when used in conjunction with electronic health records and may contribute to medical device innovation based on insights from real-world use of the medical devices.

The CDRH will provide guidance documents regarding the Leapfrog program. These mapping documents will outline a simplified regulatory pathway for new, emerging technologies to enter the market. The CDRH welcomes comment from the device industry about areas for which the Leapfrog program will be useful.

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