Washington, D.C – The Medical Imaging & Technology Alliance (MITA) – the leading 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,” said 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.”
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.
MITA is the collective voice of manufacturers of medical imaging equipment, radiopharmaceuticals, contrast media, and focused ultrasound therapeutic devices. It represents companies whose sales comprise more than 90 percent of the global market for medical imaging innovations. These products include: magnetic resonance imaging (MRI), medical X-Ray equipment, computed tomography (CT) scanners, ultrasound, nuclear imaging, radiopharmaceuticals, and imaging information systems. MITA Member company technologies are an important part of our nation’s healthcare infrastructure and are essential for the screening, diagnosis, staging, managing, and effectively treating patients with cancer, heart disease, neurological degeneration, and numerous other medical conditions.