USA – FDA Proposes New Ban of Electrical Stimulation Devices for Self-Injurious or Aggressive...
Today, the U.S. Food and Drug Administration (FDA) is proposing a ban of electrical stimulation devices (ESDs) intended to reduce or stop self-injurious or...
USA – Biocompatibility Testing of Medical Devices – Standards Specific Information for the Accreditation...
This guidance provides information on how the Biological Evaluation of Medical Devices standards are incorporated into the Pilot Accreditation Scheme for Conformity Assessment Program...
USA – FDA opens TAP
The US Food and Drug Administration (FDA) has initiated a soft launch of its Total Product Lifecycle Advisory Program (TAP), which was negotiated under...
USA – FDA recognizes three new international medical device software security standards
The US Food and Drug Administration (FDA) has recognized three new standards related to software security on medical devices. The standards address taking a...
USA – Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions
As part of FDA’s Medical Device Safety Action Plan: Protecting Patients, Promoting Public
Health (herein referred to as the “Safety Action Plan”),1 FDA committed to...
Canada – Proposed changes to the Medical Devices Regulations to address future public health...
Health Canada is proposing regulatory amendments to the Medical Devices Regulations (MDR). We're proposing to expand the current provisions under Part 1.1 of the MDR, currently...
USA – Studies linking recalled 510(k) devices to problematic predicate products are ‘warning shot’...
Two recent studies that link the recall of 510(k)-cleared medical devices to problematic predicate products should serve as a “shot across the bow” for...
USA – FDA and CMS: Americans Deserve Accurate and Reliable Diagnostic Tests, Wherever They...
Physicians heavily rely on laboratory tests to make critical decisions about their patients’ care—roughly 70% of healthcare decisions depend on laboratory test results according...
USA – Industry asks FDA to clarify voluntary malfunction reporting program requirements
Medical device industry groups are asking the US Food and Drug Administration (FDA) to provide more clarity on what products will qualify for its...
USA – Legacy devices report highlights need for data to support future policies
More data is needed to understand the risks legacy connected medical devices pose to the healthcare system, particularly in their vulnerability to cyberattack. That...
