ChatRx & ChatMD FDA Regulatory Compliance

ChatMD Device ID & Manufacturer Information

• Device ID: ChatMD v1.0.250331
• Manufacturer & Owner
  • Company Name: ChatMD
  • Address: 328 S. Michigan Street, Plymouth, IN 46563
  • Contact: Tod Stillson MD clinical@chatrx.md
  • Role: Owner and operator of the ChatMD medical device.
• Development Partner:
  • Company Name: Smart Data Enterprises Inc.
  • Address: 151 E 85th Street, #9D, New York, NY, United States
  • Contact: info@smartdatainc.net
  • Role: Responsible for engineering and software development.

Ensuring Safety, Compliance, and Trust in Digital Healthcare

At ChatRx, we are committed to delivering safe, effective, and compliant digital medical care solutions. As a medical device and telehealth platform, ChatMD and ChatRx adhere to FDA Class 1 Medical Device regulations, ensuring that every aspect of our technology meets the highest standards for patient safety and regulatory compliance.

FDA Class 1 Registration & Compliance

ChatMD is officially registered as an FDA Class 1 medical device, designed to support telehealth-based diagnosis and treatment for 39 common acute infections. Our compliance framework ensures that ChatMD operates within the guidelines of the FDA’s Software as a Medical Device (SaMD) regulations.

Key Compliance Features

✔ FDA Class 1 Registration – ChatMD is listed with the FDA as a compliant SaMD.
✔ Quality Management System (QMS) – Our internal processes meet FDA regulatory requirements.
✔ Post-Market Surveillance – We actively monitor product safety and performance.
✔ Regulatory Disclosures – All compliance documents are transparently accessible.

Regulatory Oversight & Documentation

To uphold our commitment to safety and regulatory integrity, ChatMD and ChatRx maintain comprehensive policies that outline our adherence to FTC, FDA, and HIPAA guidelines. These include:

• ChatMD FDA Class 1 Registration Information
• ChatMD FDA Labeling & Packaging Policy and Procedure
• ChatMD SaMD FDA Class 1 Compliance Features in Admin Panel & QSM
• Regulatory Disclosures for ChatRx Website Footer Trust Center
• ChatRx & ChatMD Regulatory Compliance for Product & Workflow

Ensuring Transparency & Patient Trust

Our compliance measures extend beyond regulatory obligations—we prioritize patient privacy, data security, and ethical telemedicine practices. ChatMD and ChatRx operate within HIPAA-compliant data handling protocols and follow strict FTC consumer protection guidelines.

Want to verify our compliance? Visit the official FDA Device Registration Database

Learn More About Our Compliance Policies

For a full breakdown of our compliance and regulatory framework, please visit our Trust & Safety Center or contact you can contact us at trust@chatrx.md