Nuclear Regulators Ease Burden on Some Medical Devices, Expediting New Trials
Sponsors of medical device products containing radioactive material may soon find it easier to bring the products to market under a newly proposed rule issued this week by the Nuclear Regulatory Commission (NRC).
The rule, Medical Use of Byproduct Material-Medical Event Definitions, Training and Experience, and Clarifying Amendments, is an update to a 2002 rule on the medical use of so-called "byproduct material."
According to the NRC, byproduct materials are those made radioactive by exposure to nuclear material, created as waste or through extraction from other radioactive material, or created from naturally occurring radioactive material.
Such products are commonly used for medical applications, such as in nuclear medicine, brachytherapy and teletherapy. While the US Food and Drug Administration (FDA) has regulatory authority over the devices' approval, the NRC regulates the use of most of those devices (states generally regulate X-ray machines).
Among the numerous changes proposed by the NRC in its new rule are several related to medical devices. For example, Section 35.500, Use of Sealed Sources for Diagnosis, would permit already-registered diagnostic devices using "sealed sources" of radioactive material to be used in research "in accordance with an active investigational device exemption (IDE) application accepted by FDA." Previously, new investigations would require a sponsor to first seek a license amendment, NRC explained.
The rule applies only to diagnostic medical devices, and must still be used "in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry," the proposed regulation states.
The proposed rule also revises training requirements for users of a wide range of medical devices.
A comment period is open for 120 days.