BILL ANALYSIS H.B. 1888 By: Metcalf Licensing & Administrative Procedures Committee Report (Unamended) BACKGROUND AND PURPOSE Under current law, certain FDA-regulated medical devices that incorporate boilers are subject to state boiler registration and inspection requirements, despite already being regulated at the federal level. The bill author has informed the committee that this redundancy may create unnecessary regulatory burdens on medical facilities, manufacturers, and operators and may lead to inefficiencies and increased costs. H.B. 1888 seeks to modernize exemptions from state boiler registration and inspection requirements and ensure that Texas law aligns with existing federal oversight while reducing unnecessary compliance burdens for health care providers and manufacturers by exempting unfired pressure vessels in an autoclave and boilers of a certain size that are a component of an FDA-regulated medical device from those requirements. CRIMINAL JUSTICE IMPACT It is the committee's opinion that this bill does not expressly create a criminal offense, increase the punishment for an existing criminal offense or category of offenses, or change the eligibility of a person for community supervision, parole, or mandatory supervision. RULEMAKING AUTHORITY It is the committee's opinion that this bill does not expressly grant any additional rulemaking authority to a state officer, department, agency, or institution. ANALYSIS H.B. 1888 amends the Health and Safety Code to exempt the following equipment from boiler registration and inspection requirements: unfired pressure vessels in an autoclave; and boilers that are a component of a medical device regulated by the FDA and are of a size that does not exceed: o an inside shell diameter of 16 inches; o 20 square feet of heating surface, unless the boiler is electric; o five cubic feet of gross volume, excluding the casing and insulation; and o an allowable working pressure of 100 pounds per square inch gauge. EFFECTIVE DATE September 1, 2025.
BILL ANALYSIS
# BILL ANALYSIS
H.B. 1888
By: Metcalf
Licensing & Administrative Procedures
Committee Report (Unamended)
H.B. 1888
By: Metcalf
Licensing & Administrative Procedures
Committee Report (Unamended)
BACKGROUND AND PURPOSE Under current law, certain FDA-regulated medical devices that incorporate boilers are subject to state boiler registration and inspection requirements, despite already being regulated at the federal level. The bill author has informed the committee that this redundancy may create unnecessary regulatory burdens on medical facilities, manufacturers, and operators and may lead to inefficiencies and increased costs. H.B. 1888 seeks to modernize exemptions from state boiler registration and inspection requirements and ensure that Texas law aligns with existing federal oversight while reducing unnecessary compliance burdens for health care providers and manufacturers by exempting unfired pressure vessels in an autoclave and boilers of a certain size that are a component of an FDA-regulated medical device from those requirements.
CRIMINAL JUSTICE IMPACT It is the committee's opinion that this bill does not expressly create a criminal offense, increase the punishment for an existing criminal offense or category of offenses, or change the eligibility of a person for community supervision, parole, or mandatory supervision.
RULEMAKING AUTHORITY It is the committee's opinion that this bill does not expressly grant any additional rulemaking authority to a state officer, department, agency, or institution.
ANALYSIS H.B. 1888 amends the Health and Safety Code to exempt the following equipment from boiler registration and inspection requirements: unfired pressure vessels in an autoclave; and boilers that are a component of a medical device regulated by the FDA and are of a size that does not exceed: o an inside shell diameter of 16 inches; o 20 square feet of heating surface, unless the boiler is electric; o five cubic feet of gross volume, excluding the casing and insulation; and o an allowable working pressure of 100 pounds per square inch gauge.
EFFECTIVE DATE September 1, 2025.
BACKGROUND AND PURPOSE
Under current law, certain FDA-regulated medical devices that incorporate boilers are subject to state boiler registration and inspection requirements, despite already being regulated at the federal level. The bill author has informed the committee that this redundancy may create unnecessary regulatory burdens on medical facilities, manufacturers, and operators and may lead to inefficiencies and increased costs. H.B. 1888 seeks to modernize exemptions from state boiler registration and inspection requirements and ensure that Texas law aligns with existing federal oversight while reducing unnecessary compliance burdens for health care providers and manufacturers by exempting unfired pressure vessels in an autoclave and boilers of a certain size that are a component of an FDA-regulated medical device from those requirements.
CRIMINAL JUSTICE IMPACT
It is the committee's opinion that this bill does not expressly create a criminal offense, increase the punishment for an existing criminal offense or category of offenses, or change the eligibility of a person for community supervision, parole, or mandatory supervision.
RULEMAKING AUTHORITY
It is the committee's opinion that this bill does not expressly grant any additional rulemaking authority to a state officer, department, agency, or institution.
ANALYSIS
H.B. 1888 amends the Health and Safety Code to exempt the following equipment from boiler registration and inspection requirements:
unfired pressure vessels in an autoclave; and
boilers that are a component of a medical device regulated by the FDA and are of a size that does not exceed:
o an inside shell diameter of 16 inches;
o 20 square feet of heating surface, unless the boiler is electric;
o five cubic feet of gross volume, excluding the casing and insulation; and
o an allowable working pressure of 100 pounds per square inch gauge.
EFFECTIVE DATE
September 1, 2025.