Class IIa medical device in Europe
Remote monitoring is a medical device allowing the reporting of your patients’ symptoms to their care team and the possibility to send alerts if necessary. The tool distributed by Resilience is a regulated product under European regulations and certified by the notified body GMED (certification body and French notified body in Europe) as a Class IIa medical device.
Our software service is indicated for the follow-up of cancer patients with the aim of detecting progression, recurrence or therapeutic toxicity. All the elements that make up our platform have been designed in close compliance with the most stringent international standards in terms of quality management, information system security and medical device software design.
Medical device under Enforcement Discretion in the United States (FDA)
Regulatory Status: Medical Device under Enforcement Discretion
Our solution is recognized as a medical device but does not require FDA approval due to enforcement discretion
This applies to certain digital health / RPM solutions where risks are considered low and FDA exercises limited oversight
Product composition :
Remote Patient Monitoring (RPM) features
Clinical content program for self-management
Intended Use: Resilience PRO is a digital Medical Device under enforcement discretion according to the Section 201(h)(1) of the FD&C Act. This device is intended for the remote monitoring of cancer patients by healthcare professionals and for supporting patients in the self-management of their symptoms through personalized guidance and symptom tracking
Classification: No FDA class assigned → covered under enforcement discretion
Regulatory Obligations:
21 CFR Part 820 – Quality System Regulation (QMS framework, design & manufacturing controls)
21 CFR Part 11 – Electronic records & electronic signatures compliance
US Agent: not required (since no FDA registration)
HIPAA: self-certification ongoing, legal review in progress to ensure compliance with US healthcare data privacy standards (ownership: Legal team)
Distribution in US:
No FDA registration required for distributors under enforcement discretion
We will implement formal distribution agreement to cover compliance, responsibilities, and best practices