FDA Proposes to Streamline Regulations for Radiological Products

The Food and Drug Administration is proposing to amend its radiological health regulations to “reduce regulatory requirements that are outdated and duplicate other means to better protect the public health against harmful exposure to radiation emitting electronic products and medical devices,” it said in a notice. Among other things, FDA’s proposed rule would amend record-keeping and reporting requirements for electronics and medical devices by reducing some annual report and test record requirements, and cut back on some regulatory requirements for uncertified products incorporated into an electronic product that is then certified by its manufacturer. Comments are due July 1.