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 where no approved alternative device exists, the SFDA may permit the compassionate supply of a device that does not yet hold MDMA. This is typically arranged through:
- A formal request from the treating physician or healthcare institution
- Approval from the relevant healthcare institution's ethics committee or institutional review board
- SFDA authorization for the specific patient case, submitted via GHAD by the Authorized Representative
Compassionate use supply does not require full MDMA but is subject to SFDA oversight and reporting obligations.