# TMEDS — Regulatory status

**Entity contact:** tmeds@tuce.app  
**Effective:** 2026-08-19

## Status summary

TMEDS (Timed Medication Delivery System) is a **development-stage medical device concept**.

| Statement | Status |
|-----------|--------|
| FDA cleared | No |
| FDA approved | No |
| CE marked | No |
| Available for clinical / patient use | No |
| Offered for sale as a medical device | No |
| Investigational clinical distribution | No (not authorized) |

## What the public site offers

- Information about the engineering concept and regulated pathway we are preparing
- R&D donations (no device entitlement)
- Refundable founding-supporter reservations (credit toward a *future* cleared offering; not a device pre-order)
- Hospital interest / waitlist capture for post-clearance pilots

## Pathway (planning only)

We intend to pursue an appropriate FDA pathway for a Class II–class infusion/administration device candidate under a quality system (design controls), with risk management, software lifecycle, human factors, and electrical safety standards as applicable. Exact pathway (e.g., 510(k) vs De Novo) will be determined with regulatory counsel.

## Updates

This document will be updated when regulatory status changes. Questions: tmeds@tuce.app