This final rule will amend and repeal parts of the radiological health regulations for recommendations for radiation protection during medical procedures, certain records and reporting for electronic products, and performance standards for diagnostic X-ray systems and their major components, laser products, and ultrasonic therapy products. We estimate the benefits of this rule in terms of cost savings. Cost savings to industry are derived from the reduction in labor associated with the reporting, recordkeeping, performance standards, and third-party disclosure requirements. Similarly, cost savings to FDA result from the reduction in labor hours required to review reports. The total present-value cost savings over a 20-year time period are $69.71 million at a 7 percent discount rate and $97.89 million at a 3 percent discount rate. Annualized total cost savings are $6.58 million. We estimate the costs to read the rule for all reporting respondents. The present value costs are $1.60 million, and the annualized costs calculated over a 20-year time period are $0.14 million at a 7 percent discount rate and $0.10 million at a 3 percent discount rate.

Regulatory Impact Analysis

Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance (PDF - 191KB)

Federal Register: 88 FR 3638, January 20, 2023

Docket: FDA-2018-N-3303