Compassionate Use & Novel Device Exemptions
Novel and innovative device exemptions
The SFDA may grant exemptions from specific MDMA requirements for novel or innovative devices where:
- The device addresses an unmet medical need
- Full technical documentation is not yet available
- The safety profile is sufficiently established for limited authorised use
Such exemptions are granted at SFDA discretion on a case-by-case basis and require a formal request via GHAD by the AR. Approval is not guaranteed and is subject to conditions (e.g. data collection requirements, restricted distribution).
Compassionate use / exceptional access
For individual patients with serious or life-threatening conditions, the SFDA may permit the supply of a device that does not yet hold MDMA. This is typically arranged through:
- A treating physician's formal request
- Approval from the relevant healthcare institution's ethics committee
- SFDA authorisation for the specific patient case
Compassionate use supply does not require full MDMA but is subject to SFDA oversight and reporting obligations.