US: FDA introduces new Medical Device Development Tools for sponsors
The FDA introduced a new Medical Device Development Tools (MDDT) for the investigation of medical devices. Through the MDDT program, the FDA defines tools that medical device sponsors can use in the development and evaluation of medical devices. The newly introduced tool is “Rubric for Applying CVSS to Medical Devices” belonging to the product area of cybersecurity.
The FDA defined three main MDDT categories:
- Biomarker test: a lab test or instrument used to detect or measure an indicator of biologic processes or pharmacologic responses to a treatment (biomarker).
- Nonclinical assessment model: a nonclinical test method or model (e.g. in vitro “bench,” animal or computational model) that measures or predicts device function or performance in a living organism.
- Clinical outcome assessment: measures of how a patient feels or functions. These could be, among others, observer-reported outcomes such as from a parent or caregiver, or performance outcome measures, such as measures of gait speed or memory recall.
- Examples of tools that might be eligible for qualification include: patient reported outcome rating scales, such as those used to measure pain, improved mobility, symptom relief, function, or health status and heart failure-related hospitalization.
Meditrial offers Catchtrial ePRO app for the collection of patient reported outcome (PRO).
Catchtrial ePRO App facilitates better interaction between the patient, investigator and sponsor, ensures faster trial completion, and significant cost savings.
It works with any desktop or mobile device, including Android and Apple iOS. ePRO simply allows you to stay tuned with patient health.
ePRO App features
• Manage images transfer in the virtual trial thanks to smartphone camera control
• GDPR and HIPAA compliant – no patient PHI entry required, no personal data breach
• Off-line data entry in case of no internet connection
Catchtrial electronic Patient-Reported Outcomes (ePRO) is a survey of the status of a patient’s
health that comes directly from the patient, i.e. the patient reports the data directly.
These surveys can include psychological symptoms, patient diary and general quality of life
measures, such as how the condition impacts a patient’s daily life.
Learn more about Catchtrial ePRO App!
For more details on the FDA MDDT program, please visit this page.
Contact Meditrial for immediate assistance in Europe or the US.
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This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
