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HD 604

An Act relative to airway clearance devices

194th Legislature (2025-2026) Introduced by Rodney Elliott

Massachusetts bill establishing safety and licensing standards for airway clearance medical devices used in respiratory care settings.

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Bill Summary · HD 604

Legislative bill overview

HD 604 establishes regulatory requirements and licensing standards for airway clearance devices in Massachusetts. The bill aims to ensure these medical devices meet safety and efficacy standards before distribution and use in clinical and home settings.

Why is this important

Airway clearance devices are critical for patients with respiratory conditions, cystic fibrosis, and other pulmonary diseases. Proper regulation ensures devices are safe, effective, and properly maintained, protecting vulnerable patient populations who depend on them for breathing support.

Potential points of contention

  • Cost implications: New regulatory requirements and licensing may increase manufacturing and distribution costs, potentially raising device prices for patients and healthcare systems
  • Implementation timeline: Unclear whether existing devices must comply immediately or have a phase-in period, creating uncertainty for manufacturers and providers
  • Definition scope: The bill's definition of "airway clearance devices" may be ambiguous, potentially capturing devices beyond intended scope or leaving gaps in coverage

Compiled from official sources — confirm details with the bill’s official record.

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