HBA-MPM H.B. 2179 76(R) BILL ANALYSIS Office of House Bill AnalysisH.B. 2179 By: Uresti Public Health 3/31/1999 Introduced BACKGROUND AND PURPOSE In 1990, Congress enacted the Safe Medical Devices Act (SMDA), which amended the Federal Food, Drug, and Cosmetic Act to allow federal and state governments to make improvements in the regulation of medical devices and related products, including combination products (a combination of both drug and device). Amending Texas law will provide uniformity with federal requirements and enable the state to take advantage of the improvements resulting from SMDA, including a more streamlined approach to licensing and inspecting manufacturers and distributors of combination products. H.B. 2179 amends Chapter 431, Health and Safety Code, to authorize the Texas Department of Health to determine the appropriate state regulatory process for manufacturers and distributors of combination products, thereby making the code consistent with federal law. RULEMAKING AUTHORITY It is the opinion of the Office of House Bill Analysis that this bill does not expressly delegate any additional rulemaking authority to a state officer, department, agency, or institution. SECTION BY SECTION ANALYSIS SECTION 1. Amends Subchapter A, Chapter 431, Health and Safety Code, by adding Section 431.006, as follows: Sec. 431.006. CERTAIN COMBINATION PRODUCTS. Specifies that if the United States Food and Drug Administration (USFDA) determines, with respect to a product that is a combination of a drug and device, that the primary mode of action of the product is as a drug, the person engaging in wholesale distribution of the product is subject to licensure under Subchapter I (Wholesale Drug Distributors); and that the primary mode of action of the product is as a device, a distributor or manufacturer of the product is subject to licensure under Subchapter L (Device Distributors and Manufacturers). SECTION 2. Emergency clause. Effective date: upon passage.