FDA Publishes Final Rule to Amend and Reduce Regulatory Burden on Outdated and Duplicative Requirements as They Pertain to Radiological Health Regulations

February 16, 2023By Véronique Li, Senior Medical Device Regulation Expert & Allyson B. Mullen

Sections of the radiological health regulations have been updated with the goal of lessening regulatory burdens. The regulations contain many requirements that are over 30 years old. These regulations apply to radiation emitting products, including not just medical devices but all other radiation emitting products as well.  Thus, these regulations apply to a huge variety of products.

FDA is making these updates in part due to recognition that some of the records and reporting requirements are unnecessary to comply with the Electronic Product Radiation Control (EPRC) program (sections 532, 534(a)(1), and 537(b) of the FD&C Act (21 U.S.C. 360ii, 360kk(a)(1), and 360nn(b))). FDA also noted that some of the recommended protections are outdated and redundant to Federal and State requirements, such as professional guidelines, current radiation guidance documents and industry standards that practitioners and industry rely on to ensure public health and safety.

By amending and repealing certain parts of the regulation, FDA believes that compliance to standards adequately protect public health and provide a reasonable assurance of safety and effectiveness when appropriately used by trained personnel.  Further, radiation emitting products are used in limited circumstances, such as to answer a clinical question or guide disease treatment. It is expected that, during these instances, patient risk from radiation exposure can be mitigated and minimized.

The amendments were announced in the Federal Register last month (here).  As anyone who has submitted a laser report knows, the regulations are not always clear.  It appears that some of the changes may enhance clarity and simplicity while others are more administrative in nature.

One of the most notable changes is that 21 C.F.R. § 1002.1 has been modified so that manufacturers of diagnostic x-ray products no longer need to submit initial (§ 1002.10), supplemental (§§ 1002.11), abbreviated (§ 1002.12) and annual reports (§ 1002.13).  This means that manufacturers of diagnostic x-ray systems no longer need to submit an accession number when importing products.  This should come as a relief to diagnostic x-ray manufacturers which have had to comply with both the device regulatory requirements of submitting 510(k)s, complying with the quality system regulation, and filing MDRs, among other things, as well as the radiation emitting product regulations.

The final rule will be effective February 21, 2023.  This is an ideal time for FDA to make these changes as annual reporting for radiation emitting products are not due until September 1.  Manufacturers, therefore, have ample time to familiarize themselves with the changes.

Categories: Medical Devices