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FDA Proposal to Reduce Burdens on Low-Risk Radiation Emitting Products Like Microwaves and Ultrasonic Devices

April 2, 2019

On April 1, 2019, the U.S. Food and Drug Administration (FDA) published a proposed rule to reduce and eliminate outdated and unnecessary records and reporting requirements for an array of non-medical electronic products that emit radiation such as microwaves, lasers, television receivers, and non-medical ultrasound products. (84 FR 12147).[1]

The proposed rule also covers medical devices extensively. This alert focuses on the impacts on non-medical electronic products.

FDA is in the process of streamlining and eliminating a number of outdated, redundant or otherwise burdensome requirements that have no bearing on public health, particularly for non-medical, low-risk products such as microwave ovens, ultrasonic occupancy sensors, and low-power lasers. To do so, FDA is currently proposing to eliminate the pre-market “product reports” for many of these products, as well as annual reports, and other reports like the supplemental reports and abbreviated reports required by FDA’s regulations. Most notably, the proposed rule would exempt non-medical ultrasonic products and certain televisions from almost all currently required records and reporting obligations. Stakeholders are encouraged to submit comments to the FDA, which are due by July 1, 2019.

Background

The FDA has the authority to regulate any “electronic product” which “emits … electronic product radiation.” FDCA, 21 U.S.C. 360hh(2)). FDA’s Center for Devices and Radiological Health (CDRH) previously implemented this authority in a conservative and broad manner, applying burdensome reporting and recordkeeping requirements on all categories of products that meet that definition. (21 CFR parts 1000 to 1050).

Examples of covered electronic products include a number of medical devices – diagnostic x-ray or ultrasound imaging devices, microwave or ultrasound diathermy devices – all products squarely within FDA’s traditional regulatory ambit. But a number of non-medical products are also covered by FDA’s current regulation: namely, microwave ovens, entertainment lasers, non-medical sonic products, as well as television receivers and monitors (video displays).

Under current FDA requirements, all covered products are subject to a mix of product reports, supplemental reports and annual reports, as well as related recordkeeping obligations. The requirements are set forth at 21 C.F.R. Part 1002, Table 1.

Proposed Amendments for Electronic Products

FDA is proposing to streamline reporting requirements for electronic products codified at 21 C.F.R. Part 1002, Table 1. The proposed amendments seek to eliminate reporting requirements for low-risk products, which the Agency explains, will enable it to refocus Agency resources on “high-priority aspects of radiation safety for products with greater risk.” Below we summarize the proposed amendments for non-medical electronic products.

Under FDA’s proposed rule, all non-medical acoustic products and certain television receivers would be entirely exempted from FDA’s current requirements. This is a significant development and represents a sea-change for manufacturers of these products. The proposal would significantly decrease the regulatory burdens for products which many, including FDA,have long recognized pose little to no radiological risk to consumers.

FDA’s proposed rule also seeks to reduce the reporting requirements for a number of other product categories by removing the requirements for pre-market product reports, supplemental reports, and annual reports for the following categories:

  • Computed tomography
  • x-ray systems
  • x-ray control
  • x-ray high voltage generator
  • beam-limiting devices
  • spot-film devices and image intensifies manufactured after April 26, 1977, and
  • T lamps.

In addition, FDA is proposing to remove the following products from the requirements for abbreviated reports: (a) Xray table or cradle, (b) x-ray film charger, (c) vertical cassette holders mounted in a fixed location and cassette holders with front panels.

Finally, FDA is also proposing to remove the following products from the requirements for supplemental reports: (a) Television with ≥0.1mR/hr IRLC 5, (b) microwave ovens (§ 1030.10), and (c) class IIa, II, IIIa lasers and products other than class I products containing such lasers. Under the proposed rule, manufacturers of these categories of product must continue to submit product reports and annual reports. FDA explains in the proposed rule that it believes supplemental reporting is no longer necessary for these products in light of the information required to be conveyed to the Agency in the product reports coupled with the relatively lower-risk of these products.

Of note, in all cases discussed above, the proposed amendments do not remove the general requirement to notify the FDA of defects and accidental exposure incidents pursuant to 21 C.F.R. Part 1102 and 1003.

Should you have any questions regarding the implications of the final rule for your business, or any other questions concerning FDA CDRH requirements, please contact Roger Miksad (rmiksad@wileyrein.com) or Brian P. Sylvester (bsylvester@wileyrein.com).

                                                                                                                                     

[1] The proposed rule also covers medical devices extensively. This Alert focuses on the impacts on non-medical electronic products.