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Category Archives: FDA Updates

19 Sep

The Consumer Hand Sanitizers And Wipes Are Under New FDA Scrutiny

As of June 29, 2016, FDA has started collection of additional safety and effectiveness data for certain active ingredients present in over-the-counter (OTC) consumer antiseptic rubs. The consumer antiseptic rubs include hand sanitizers and antiseptic wipes that are intended to be left on and not rinsed off with water. These products are used by consumers

08 Sep

The New Normal For Consumer Antiseptic Wash Manufacturers!!

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

07 Sep

The deadline for the UDI compliance is fast approaching and at this juncture the FDA rule to extend the deadlines for certain class II device is a big relief for some labelers!!!

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

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

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