Compliance & Regulations
Understanding and exceeding federal requirements for medical supply procurement
Our Compliance Commitment
Lumbee Advanced Medical Supply maintains strict adherence to all federal, state, and local regulations governing medical supply distribution. Our compliance program ensures that every product meets or exceeds regulatory requirements.
FDA Regulations
All medical supplies meet FDA standards for safety and efficacy
- FDA registration and listing
- 510(k) clearance for applicable devices
- Good Manufacturing Practices (GMP) compliance
- Proper labeling and packaging requirements
GSA Schedule Requirements
Working toward GSA MAS contract compliance
- Trade Agreements Act (TAA) compliance
- Commercial sales practices disclosure
- Price reduction clause adherence
- Industrial funding fee payments
HIPAA Compliance
Protecting patient information in all transactions
- Business Associate Agreements (BAA)
- Secure data transmission protocols
- Employee HIPAA training
- Incident response procedures
Quality Standards
Maintaining highest quality in products and services
- ISO 9001:2015 quality management
- Product traceability systems
- Regular quality audits
- Continuous improvement processes
Important Compliance Information
As a new business established in 2025, we are actively working to obtain all necessary certifications and registrations. Our current status:
- Active: DUNS Number, SAM.gov Registration, Native American Owned
- In Progress: GSA Schedule, SBA VOSB, HUBZone Certification
- Planned: Additional specialized certifications
Compliance Resources
Compliance Checklist
Federal requirements for medical supply vendors
Certification Guide
Overview of our certifications and compliance status
Quality Assurance
Our quality control and assurance procedures