The Food and Drug Administration (FDA) is issuing a final rule to amend the medical device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation to harmonize and modernize the regulation. The FDA conducts objective economic analyses of all important proposed and final regulations, which includes the Regulatory Impact Analysis (RIA) as well as other analyses mandated by various statutes and executive orders. 

The Department of Health and Human Services describes an RIA as “a well-established and widely-used approach for collecting, organizing, and analyzing data on the impacts of policy options, to promote evidence-based decision-making. It provides an objective, unbiased assessment that is an essential component of policy development, considering both quantifiable and unquantifiable impacts. Along with information on legal requirements, general policy goals, the distribution of the impacts, and other concerns, it forms the basis of the ultimate policy decision.

The RIA describes the effects of the regulation rather than advocating a particular approach. The arguments supporting the agency’s decision are provided separately in the preamble to the Federal Register notice for the proposed and final regulation. The core of the RIA is an assessment of the benefits and costs of regulatory and other policy options in comparison to a “without regulation” (or “no action”) baseline. In addition, the RIA includes supplementary analyses that respond to various statutory and administrative requirements.” The Final RIA for the amendments to the medical device CGMP of the QS regulation estimates annual benefits of $561 million and annual costs of $7.3 million, at a 3% discount rate in a 10-year period.

Regulatory Impact Analysis

Medical Devices; Quality System Regulation Amendments (PDF 783 KB)

Federal Register: [TBD] 
Publication Date: 10/07/1996
Docket: FDA-2021-N-0507