The International Medical Device Regulators Forum is inviting stakeholder comment on a draft proposal for using real-world data from patient registries in regulatory decisionmaking.
Stakeholders should compare the proposal to their current processes and consider closing any evidence gaps, IMDRF said. The assessment elements in the proposal are expected to promote consistency, predictability and transparency in maximizing the use of real-world data in evaluating device safety and effectiveness.
The draft proposes recommendations on the following regulatory uses:
The proposed assessment elements are intended to promote convergence of regulatory approaches, enhance technical capabilities of regulators and stakeholders and generate faster evidence.
The proposed elements for assessing registries for regulatory uses include information on device identification, linkability, transparency and governance, and quality and methodology processes leading to actionable data.
For device identification, the draft document says, unique device identifiers should be used as well as production identifiers. When a UDI is not available, registries should record global trade item numbers, labeler identification codes or processor product identification codes.
The proposal recommends that device registries remain transparent by maintaining a public website that describes the aims of the registry, includes information about the governance processes, and how the registry is funded, as well as how to participate in the registry. Governance policies and processes should include policies on handling conflicts of interest, data access, reports and information, verification of data by regulators, and patient data protection and data security.
A section on quality and methodology processes notes that since registries are usually established for non-regulatory purposes, regulators should carefully consider whether the variables collected by the registry are sufficient in scope for regulatory purposes.
For analysis and interpretation of registry-generated data, a common set of data elements should be used along with a common definition framework and pre-specified time intervals for data collection and outcome analyses.
The list of variables should include demographic factors, medical history/co-morbidities, procedure/device information, operators/physicians, follow-up information and outcomes. In addition, a distinction should be made between the elements that all registries would share and the specifics needed in each specialty area.
The IMDRF’s Patient Registries Working Group acknowledged that the data produced by a registry “may be suitable for making one type of regulatory decision but not others,” and individual country regulators should assess data independently and decide what actions to take.
Comments may be submitted to the working group until Dec. 1, and a proposed final document will be submitted to IMDRF in February 2018.
Read the draft proposal here: www.fdanews.com/10-04-17-Deviceregistry.pdf.