- FDA has proposed a rule that would repeal or amend some regulations governing radiation-emitting electronic products and medical devices that the agency has identified as outdated or duplicative.
- Regulations to be revised or repealed under the proposed rule include recommendations for radiation protection during some medical procedures; certain records and reporting for electronic products;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.
- Cost savings to the agency and industry from the reduction in labor hours to review reports are estimated between $62.8 million and $88.2 million over a 20-year period.
Reducing regulatory burdens is a Trump administration priority. The president in 2017 issued an executive order that requires federal agencies to identify two regulations to be eliminated for each new regulation imposed. FDA said it believes the revised radiological health regulations will continue to protect the public against harmful exposure to radiation-emitting electronic products and medical devices while reducing regulatory burdens.
The proposed rule would repeal radiation protection recommendations that FDA believes have become unnecessary due to the agency's safety communications and other mechanisms that provide more comprehensive guidance to protect patients and health professionals from radiation exposure.
Another provision would remove or reduce some annual reports and test records requirements that may be duplicative of other reporting that FDA and state regulators require. The agency proposes allowing quarterly reporting for accidental radiation occurrences (AROs) not associated with a death or serious injury.
Manufacturers would no longer be required to submit two additional copies with the original documents for variance applications.
Assemblers who install certified components of diagnostic X-ray systems would no longer have to submit reports of assembly to the agency. The regulations would be amended so that assemblers submit reports to the purchaser and state agencies where applicable.
The proposal would also reduce regulatory requirements for uncertified laser products intended for use as a component in a finished electronic product that is then certified by the manufacturer. Additionally it would reduce requirements for certified and unmodified laser products not intended for use as a component or replacement and that are incorporated into another product.
Performance standards for sonic, infrasonic and ultrasonic products would be repealed because they are limited to a subset of physical therapy devices with an outdated standard. The agency considers the premarket medical device regulations sufficient to ensure the safety of ultrasonic therapy products.
Public comments on the regulatory changes will be accepted for 90 days after the proposed rule is published in the Federal Register.