The US Food and Drug Administration (FDA) recently announced its qualification of the Apple Atrial Fibrillation (AFib) History Feature through the Medical Device Development Tools (MDDT) program. The MDDT program is intended to promote innovation and device development by providing medical device sponsors with scientific assessments the FDA will accept for measuring the safety and efficacy of their devices. The Apple AFib History Feature, which uses pulse rate measurements collected by an Apple Watch to measure a wearer’s AFib burden, is the first digital tool qualified by the FDA as part of the MDDT program and reflects the FDA’s increased focus on innovation.
IN DEPTH
THE MDDT PROGRAM
The MDDT program was developed by the FDA to improve predictability and efficiency in medical device development and the regulatory review process. The program achieves this by qualifying tools (i.e., medical device development tools) for measuring the safety and efficacy of medical devices that developers know the FDA will accept. Providing a set of accepted tools that can be used to support the approval of a new medical device promotes innovation by reducing uncertainty in the development process and reducing the need to develop or support the measure used to demonstrate the efficacy and safety of a new device. The FDA hopes the program will also incentivize the development and widespread acceptance of new MDDTs by offering a pathway for tool developers and device sponsors to gain assurance from the FDA that use of the tool will be accepted when used as qualified.
The FDA qualifies a range of tools through its MDDT program, from computational and animal models to digital health technologies like sensors or wearables. The FDA places MDDTs into three different categories:
- Non-Clinical Assessment Models: Non-clinical test models designed to measure or predict important parameters of device effectiveness, performance and safety.
- Biomarker Tests: Biomarkers can be important signals of a device’s performance and be used to assess risk and safety concerns and predict patient outcomes. Biomarker tests are designed to measure or detect biomarkers.
- Clinical Outcome Assessment: These assessments describe a patient’s own perceptions, functioning or survival and can be collected in clinic or remotely. They may be reported by a patient, a non-clinical observer (e.g., a caregiver or family member), a healthcare provider or through the performance of a task or activity.
MDDTs must go through a two-phase qualification process. First, in the Proposal Phase, the FDA asks the submitter of a potential MDDT to provide certain information about the tool, the data collection plan for the tool and context of use for the tool. During this phase, the FDA may provide feedback to submitters on their plan to gather supporting evidence for the tool’s qualification.
Next, during the Qualification Phase, the FDA asks the submitter to provide the evidence and data collected based on the qualification data collection plan developed during the Proposal Phase. Tools that are adequately supported by the collected evidence are qualified as MDDTs in the specific contexts of use supported by the evidence.
RECENTLY QUALIFIED MDDTs SPOTLIGHT INNOVATION AND USEFULNESS OF WEARABLES IN DEVICE DEVELOPMENT
Since 2017, the FDA has qualified 17 MDDTs. Among the three MDDTs added so far this year is the Apple AFib History Feature, which is the first digital MDDT. The tool analyzes the data to identify periods of irregular heartbeats consistent with AFib and estimates the amount of time spent in AFib (the AFib burden) during the past week. The clinical value of assessing the AFib burden has been recognized by both the FDA and medical device developers. The Apple AFib History Feature may be used as a secondary effectiveness endpoint within clinical studies evaluating the safety and effectiveness of cardiac ablation devices but is not intended to replace the findings of primary endpoints for cardiac ablation devices.
In its qualification of the tool, the FDA observed that collecting valuable clinical data through widely available and familiar wearables could address data acquisition challenges, from patient compliance and potential placebo effects to technical difficulties with collecting certain measures without an implanted device. Device developers across markets are looking for new tools to address data collection challenges and reduce uncertainty in the device approval process. This recent qualification not only illustrates the still unmet tool needs of device developers but also highlights how valuable wearable technologies and sensors can be in addressing this need.
The qualification of a digital MDDT for use in clinical devices follows closely behind the FDA’s guidance on the use of digital health technologies (DHTs) for data acquisition in clinical studies, which was finalized in December 2023. A DHT is “a system that uses computing platforms, connectivity, software, and/or sensors, for health care and related uses.” The FDA’s 2023 finalized guidance builds on draft guidance from 2021 and provides recommendations on using DHTs for remote data acquisition in clinical investigations of medical products. The guidance addressed selecting DHTs for use in clinical studies, describing DHTs in regulatory filings, validating DHTs and collecting data for trial endpoints, DHT data retention and protection, managing risks of using DHTs, and the roles of sponsors and investigators related to the use of DHTs. Both the qualification of the first digital tool through the MDDT program and the FDA’s recent guidance on the use of DHTs in clinical studies reflect the need for more convenient and reliable methods for collecting data measuring safety and effectiveness in clinical investigations of new devices and drugs.
Development of a new tool that addresses existing industry data acquisition challenges can be a valuable source of revenue, as can qualification of a tool in the MDDT program, which can indicate regulator acceptance to customers and investors alike.
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