On September 2, 2016, FDA issued a final rule for over-the-counter (OTC) consumer antiseptic washes that banned certain active ingredients previously used in these products. The consumer antiseptic wash products include hand soaps, hand and body washes that are intended for use with water and are rinsed off after use. The new rule prohibits 19
FDA has extended the compliance date for UDI label and GUDID submission requirements to September 24, 2018, for certain class II devices!! FDA has also clarified that the UDI and GUDID compliance date for certain device constituents of certain combination products will be September 2018. The UDI and GUDID extension applies to the below 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
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
Changes for the CE mark requirements. Supplied by mdi-Europa Below is a short summary of the most important changes that are coming our way with the new MDR. 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
(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
As per, Pediatric Medical Device Safety and Improvement Act (PMDSIA) of 2007, “If the course of the disease or condition and the effects of the device are sufficiently similar in adults and pediatric patients, the Secretary may conclude that adult data may be used to support a determination of a reasonable assurance of effectiveness in
FDA Draft guidance for your comments Medical devices are used by people of not only different geographic variables but also demographic variable like Age, Sex, Race and Ethnicity. The primary intent of this draft guidance us to improve the quality, consistency and transparency of data regarding the performance of medical devices within specific age, race,
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
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
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