Pennsylvania 2025-2026 Regular Session

Pennsylvania Senate Bill SB804

Introduced
6/4/25  

Caption

Providing for medical devices.

Impact

The bill proposes significant changes to existing state laws by modifying the regulatory framework governing medical devices. If enacted, SB804 would potentially allow faster approvals for innovative devices while maintaining necessary regulatory oversight. This change is intended to position the state as a leader in medical technology, attracting businesses and investments in the healthcare sector. However, there are concerns about the implications for patient safety and the adequacy of regulatory scrutiny in the pursuit of quicker approvals.

Summary

Senate Bill 804 focuses on the regulation and approval process of medical devices within the state. It aims to streamline regulations to facilitate innovation in healthcare technology while ensuring that devices meet safety and efficacy standards. The bill is positioned as a way to encourage the development and accessibility of advanced medical devices, contributing to improved healthcare outcomes for patients.

Sentiment

Overall, the sentiment surrounding SB804 has been mixed. Supporters, including many advocates from the medical technology industry, argue that the bill is essential for fostering innovation and making advanced medical devices more accessible to patients. Conversely, critics, including some healthcare advocacy groups, express apprehension that the expedited process could compromise patient safety and lead to inadequate evaluation of new devices.

Contention

Key points of contention related to SB804 include the balance between encouraging innovation and maintaining rigorous safety standards. Critics argue that streamlined regulations may reduce necessary checks and balances, which are critical for ensuring that medical devices are safe for public use. Furthermore, there are debates about the transparency of the approval process and how it impacts consumer trust in medical technologies, which are vital for public health.

Companion Bills

No companion bills found.

Previously Filed As

PA SB1301

Providing for medical devices.

PA SB668

Providing for certified medication aides; and imposing duties on the Department of Health.

PA HB1358

Providing for healthy outdoor public grounds; and imposing duties on the Department of Health, the Department of Environmental Protection and the Department of Agriculture.

PA HB294

In general provisions relating to health care, further providing for applicability, for definitions and for criminal penalties; in living wills, further providing for emergency medical services; in out-of-hospital nonresuscitation, further providing for definitions, for orders, bracelets and necklaces, for revocation, for absence of order, bracelet or necklace and for emergency medical services, repealing provisions relating to advisory committee and providing for discontinuance; and providing for Pennsylvania orders for life-sustaining treatment.

PA HB1941

Providing for cancer survivor recognition.

PA HB2592

Further providing for drug overdose medication.

PA HB1221

In school health services, further providing for possession and use of asthma inhalers and epinephrine auto-injectors and providing for school administration of adrenal insufficiency medication.

PA SB500

In public assistance, providing for medical assistance coverage for pasteurized donor human milk.

PA HB1111

In public assistance, providing for medical assistance coverage for pasteurized donor human milk.

PA HB1212

In general provisions relating to health care, further providing for applicability, for definitions, for criminal penalties, for emergency medical services, for definitions, for orders, bracelets and necklaces, for revocation, for absence of order, bracelet or necklace and for emergency medical services, repealing provisions relating to advisory committee and providing for discontinuance and for Pennsylvania orders for life-sustaining treatment; and making editorial changes.

Similar Bills

PA SB1301

Providing for medical devices.

NC S600

Improve Health and Human Services

CA AB2300

Medical devices: Di-(2-ethylhexyl) phthalate (DEHP).

NC H592

Toxic-Free Medical Devices Act of 2025

MN SF188

Ortho-phthalate testing results reporting of packaged food requirement

CA AB1210

Sodium nitrite.

CA AB2901

Cleaning Product Right to Know Act of 2017.