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News and Info

11 Jul

Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices!!

Electromagnetic Compatibility (EMC) is the ability of a device to function safely and effectively in its intended electromagnetic environment, including immunity to electromagnetic disturbance (interference), without introducing excessive electromagnetic disturbances (emissions) that might interfere with other devices. EMC information in a submission is reviewed based on the risk associated with EMC malfunction or degradation of

08 Jul

Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Third-Party Review under the Food and Drug Administration Modernization Act!! FDA Wants your Comments…

As per the paperwork reduction act of 1995 (the PRA), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an

05 Jul

Overview of the biggest changes brought about by the IVDR

(IVDD for EU supplied by mdi Europa) elow is a short summary of the most important changes that are coming our way with the new IVDR. Some of these have been discussed before in our newsletters and / or mailings, however, the below article gives another complete overview: Liability: Insurance coverage for manufacturers will be

16 Jun

Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions!!

Draft Guidance for your comments This draft guidance document provides clarity for FDA staff and industry regarding the benefit and risk factors FDA may consider in prioritizing resources for compliance and enforcement efforts to maximize medical device quality and patient safety. FDA believes that explaining the factors listed in this draft guidance document will improve

10 Jun

Dissemination of Patient-Specific Information from Devices by Device Manufacturers

This FDA draft guidance provides recommendations to industry, healthcare providers, and FDA staff about the mechanisms and considerations for device manufacturers to facilitate the appropriate and responsible dissemination of patient-specific information recorded, stored, processed, retrieved, and/or derived from medical devices from manufacturers and sharing such information with patients when they request it. FDA believes that

27 May

Get your food defense plans ready!!

FSMA Final Rule for Mitigation Strategies to Protect Food against Intentional Adulteration!! The FDA Food Safety Modernization Act (FSMA) final rule is aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply. Rather than targeting specific foods or hazards, this rule requires

06 Apr

FDA Final Rule on Sanitary Transportation of Human and Animal Food

As a part to protect the people from various illnesses resulting from food contamination during transportation because of unsanitary transportation practices, FDA issued a final rule on Sanitary Transportation of human and animal food. The Final rule is the sixth major rule under the Food Safety Modernization Act (FSMA). The rule strengthens the Sanitary Food

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