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  6. Clinical Outcome Assessments (COAs) in Medical Device Decision Making
  1. Division of Patient-Centered Development

Clinical Outcome Assessments (COAs) in Medical Device Decision Making

Resources for Using COAs
PRO Report
PRO Compendium (XLS)

At the FDA's Center for Devices and Radiological Health (CDRH), we strive to ensure patients and their care partners remain the focus of our regulatory decision-making process. One way we do that is by encouraging the inclusion of clinical outcome assessments (COAs) in the evaluation of medical devices.

On this page:

About Clinical Outcome Assessments

A clinical outcome assessment (COA) describes or reflects how a person feels, functions, or survives and can be reported by a health care provider, a patient, a non-clinical observer (such as a parent), or through performance of an activity or task. There are four types of COAs: 

  • Patient-reported outcomes (PROs),
  • Clinician-reported outcomes (ClinROs),
  • Observer-reported outcomes (ObsROs), and
  • Performance outcomes (PerfOs).

While each type of COA focuses on the patient, they provide a different perspective on a patient's health status.

PROs provide information on the patient's health condition as directly reported by the patient, without outside interpretation from anyone. These outcomes are assessed using PRO instruments such as questionnaires, numeric rating scales, or diaries.

ClinROs are reports coming from a trained health-care professional regarding their interpretation of signs or behaviors that can be observed related to a patient's disease or condition.

ObsROs are assessments of observable signs, events, or behaviors related to a patient's health condition as reported by individuals who observe the patient in daily life, like parents or caregivers.

PerfOs are measurements collected when a patient is asked to complete a well-defined, repeatable, and standardized task, such as reading an eye chart.

How CDRH Uses COAs in Regulatory Decision Making

For regulatory purposes, high-quality information from COAs can provide valuable evidence for benefit-risk assessments. They can also be used in medical device labeling to communicate the effect of a treatment on patient symptoms and functioning. COAs may be used to determine who is eligible for a clinical study and measure how well the device performs in treating or diagnosing the condition. COAs may also be used to help measure the safety of the device. Evidence from COAs may also be useful to payors and healthcare providers.

COA Case Studies

These case studies highlight the roles COAs can play in clinical investigations supporting medical device submissions. They are not intended to be a comprehensive review of the clinical studies associated with each submission.

CDRH Collaborations, Sample Articles, and Workshops on Clinical Outcome Assessments

CDRH regularly collaborates with professional societies, academic researchers, patient groups, public-private partnerships, and other stakeholders to advance the development and validation of COAs for regulatory use. For additional information about CDRH's collaborative work and articles related to COAs, see the Collaborations and Articles sections below. For additional information about our workshop on COAs, see Medical Devices Virtual Public Meeting - Patient-Reported Outcomes (PROs) and Medical Device Evaluation: From Conception to Implementation.

Collaborations

Sample Articles

Incorporating COAs in a Regulatory Submission

If you are interested in incorporating COAs in your regulatory submissions, CDRH has multiple resources to help with selecting, using, developing and modifying appropriate COAs. The FDA has issued guidance documents that may help inform your approach to including COAs in the evaluation of medical devices.

Q-submission: We invite sponsors to discuss their plan to use COAs, including adapting or developing PRO instruments, with CDRH through the Q-submission program. A pre-submission can initiate early discussions with regulatory staff, as described in the guidance document Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.

Medical Device Development Tools: COAs are one type of tool that can be qualified under the Medical Device Development Tools (MDDT) program. This program is intended to facilitate device development and timely evaluation of medical devices, and promote innovation, by providing a more efficient and predictable means for collecting the necessary information to support regulatory submissions and associated decision making. The FDA qualifies tools that medical device sponsors can use in the development and evaluation of medical devices. Qualification means CDRH has evaluated the tool and concurs with available supporting evidence that the tool produces scientifically-plausible measurements and works as intended within the specified context of use. See Qualified Medical Device Development Tools (MDDTs) for a list of qualified tools.

PRO Report: This document provides more detailed information on PROs. It discusses the value of using PROs in regulatory submissions, reimbursement decisions, and clinical practice. Additionally, CDRH efforts and accomplishments to date relating to PROs are highlighted.

PRO Compendium: The PRO Compendium (XLS) lists some, but not all, PRO instruments that have been used and reported in medical device premarket clinical investigations submitted to CDRH. We encourage sponsors interested in using a PRO instrument in a clinical investigation to schedule a pre-submission meeting to discuss their plans.

Contact Us

If you have questions about clinical outcome assessments, email CDRH-PRO@fda.hhs.gov.

 

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