As a part of The Public Health Security and Bio-terrorism Preparedness and Response Act of 2002 (the Bio-terrorism Act) FDA established regulation that require Food facility to be registered with FDA and give advance notice to FDA on shipments of imported food. The FDA Food Safety Modernization Act (FSMA), enacted on January 4, 2011, amended
Background The FDA Total Product Life Cycle (TPLC) database combines data from various CDRH databases (data sources) to present an integrated record of premarket and postmarketed activity for medical devices. A critical bug in the FDA CDRH TPLC database prevented the names of some 510K companies from being displayed appropriately. Apparently the FDA IT team
On September 21, 2016 FDA issued a Draft guidance to assist Drug Sponsor and Device Manufacturer to encourage coordination in development of Antimicrobial Drugs and Antimicrobial Susceptibility Test (AST) devices so that AST device can be cleared at the time of NDA or shortly after that. AST is an important component in development of new
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
The FDA Food Safety Modernization Act (FSMA) which aims to ensure the safe supply of food into USA was enacted into law in 2011.FDA has announce a total of $21.8 million funding to support 42 states in successful implementation of product Safety rule under FSMA. Based on the number of farms growing the covered products
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
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