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Bill

SB 804

An Act amending Title 35 (Health and Safety) of the Pennsylvania Consolidated Statutes, providing for medical devices.

2025-2026 Regular Session Introduced by Lisa Boscola and 8 co-sponsors

SB 804 amends Pennsylvania health and safety law to regulate medical devices, currently in appropriations review after committee amendments.

Referred to Health
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Bill Summary · SB 804

Legislative bill overview

SB 804 amends Pennsylvania's Health and Safety code to modify regulations governing medical devices. The bill has progressed through committee review and amendment processes, currently undergoing appropriations consideration. The specific provisions are not detailed in the available action history, making comprehensive analysis of exact regulatory changes limited.

Why is this important

Medical device regulations affect patient safety, healthcare costs, and the accessibility of treatments across Pennsylvania. Changes to device approval, labeling, reimbursement, or liability standards can influence healthcare providers' operations and patient outcomes. Pennsylvania's approach may also influence other states or set precedent for device regulation.

Potential points of contention

  • Scope ambiguity: Without detailed bill text, key disagreements likely center on which devices fall under new regulations and how stringently they're controlled
  • Cost implications: Medical device regulations often increase compliance costs for manufacturers and healthcare facilities, creating tension between safety standards and affordability
  • Liability and manufacturer protections: Bills typically balance consumer protection against industry concerns about liability exposure and regulatory burden

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

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