MDIC Patient-Centered Benefit-Risk (PCBR) Framework
The MDIC PCBR Framework helps include what patients value most—like benefits and risks—when deciding whether a medical device should be approved or used. It uses patient input to make benefit-risk assessments more personal and meaningful.
At a glance
Use when
Conducting regulatory submissions for medical devices, designing patient engagement strategies, performing benefit-risk assessments with patient input, supporting post-market evaluations
Avoid when
Patient input is inaccessible or unrepresentative, when rapid decisions are needed without time for patient engagement, or when the device has no meaningful patient-reported outcomes
Inputs
Patient preference data, clinical evidence on benefits and risks, regulatory context, device type and intended use
Outputs
Structured benefit-risk assessment incorporating patient perspectives, guidance on method selection, documentation for regulatory submissions
How it works
Developed through a collaboration between the Medical Device Innovation Consortium (MDIC) and the FDA in 2016, the Patient-Centered Benefit-Risk (PCBR) Framework provides a structured approach and catalog of methods to integrate patient preference information into regulatory decision-making for medical devices. It supports the use of patient input across the product lifecycle, from pre-market evaluation to post-market surveillance, enhancing the relevance and transparency of benefit-risk assessments.
- HTA domains
- Clinical Effectiveness, Patient and Social Aspects
- Categories
- AppraisalEvidence Synthesis
- Assumptions
- Patients can meaningfully express preferences about health outcomes; patient input improves decision-making quality; preference data can be collected reliably and ethically
- Strengths
- Enhances regulatory decision-making with real patient insights; provides a flexible, method-agnostic framework; supports use across the product lifecycle; developed with FDA collaboration for regulatory relevance
- Limitations
- Requires robust patient engagement infrastructure; quality of input depends on study design and population representativeness; may be challenging to standardize across diverse devices and conditions
- Also known as
- PCBR Framework, MDIC Patient-Centered Benefit-Risk Framework
Questions this answers
- › How can patient preferences be systematically included in benefit-risk assessments?
- › What methods are available to elicit and quantify patient preferences for medical device outcomes?
- › How do patient perspectives on risks and benefits differ from clinician or regulator views?
- › When and how should patient preference information be used in regulatory decisions?
- › What are best practices for applying patient-centered data across the medical device lifecycle?
- › How can patient input improve the transparency and legitimacy of regulatory evaluations?
References & sources
Similar by meaning
Beta record. Based on the original catalogue summary; primary-source enrichment pending.