The Medical Imaging & Technology Alliance (MITA)—the trade association representing manufacturers of medical imaging equipment, radiopharmaceuticals, contrast media, and focused ultrasound therapeutic devices—has submitted comments to the National Institute for Standards and Technology (NIST) requesting clarification of its definition of consumer IoT products to distinguish it from non-consumer products in its recent draft document, “Consumer Cybersecurity Labeling for IoT Products – Discussion Draft on the Path Forward.”
“In a previous draft update, NIST recognized a difference in complexity between ‘consumer’ and ‘non-consumer’ categories and affirmed that medical imaging devices—among other regulated devices—already adhere to rigorous oversight and labelling requirements. We appreciate these efforts and want to ensure that this distinction continues to carry over into future work on this issue,” says Patrick Hope, executive director, MITA.
“Including this clarification will prevent duplicative efforts, limit unnecessary administrative burden, and reduce confusion for hospitals and physicians. It also underscores the need to separate regulatory treatment of medical devices compared to consumer goods in other areas,” Hope adds.
MITA encourages NIST to apply a similar working definition to consumer IoT products and other consumer-specific labelling criteria. that it did to consumer software.
To read MITA’s full comments, click here.
