Post-Market Compliance in the U.S. – Sales, Surveillance, and Recalls for Rollators

Entering the U.S. medical market isn’t the end of compliance for brands like RELAXSMITH ROLLATOR—it’s the beginning of a lifecycle commitment. This article outlines the ongoing regulatory and operational responsibilities required for rollator sales and support across the United States.

1. Marketing & Claims

• Truthful Promotion: All marketing materials must reflect cleared indications only—no unsubstantiated performance claims.
• FDA Scrutiny: Advertising, websites, and social media may be reviewed by FDA’s Office of Prescription Drug Promotion (OPDP).
• RELAXSMITH ROLLATOR Controls: Centralized content review team checks all promotional assets before release.

2. Distribution Controls

• Tracking Systems: Lot/batch numbers must support traceability through warehouses and retailers.
• Authorized Distributors: RELAXSMITH ROLLATOR signs quality agreements with all U.S. partners to align SOPs and data reporting.
• Channel Visibility: CRM systems log serial numbers and shipment paths for each unit sold.

3. Complaint Management

• Timeliness: All end-user complaints must be logged and responded to within FDA-mandated timeframes.
• Root Cause & CAPA: Complaint investigation may lead to Corrective and Preventive Actions (CAPA).
• RELAXSMITH ROLLATOR Tooling: A Salesforce-based system tracks complaint origin, product batch, and response steps.

4. Medical Device Reporting (MDR)

• Mandatory Reporting: Any serious adverse event must be reported to FDA within 30 calendar days.
• Voluntary Reports: Submitted by healthcare professionals or patients can trigger inspections or safety alerts.
• RELAXSMITH ROLLATOR Process: QA team reviews all complaints for MDR thresholds and maintains FDA submission logs.

5. Recall Preparedness

• Recall Plan: Every manufacturer must have a documented recall procedure reviewed annually.
• Voluntary Recalls: Can be initiated when nonconformance or risk is identified preemptively.
• Mock Drills: RELAXSMITH ROLLATOR runs simulated recalls to test readiness and distributor coordination.

6. Continuous Improvement

• Annual Management Review: FDA expects documented strategic reviews of quality and performance data.
• Training Refreshers: Sales, support, and service staff undergo annual regulatory refresher courses.
• Technology Upgrade: AI-enhanced monitoring tools improve complaint triage and customer safety prediction.