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EPA delists zinc sites – Times News Online
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Devil Is Always in the Details: FDA Updates Device Classification Regulations To Remove Certain Software Functions | Arent Fox
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On April 16, the U.S. Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) published a notice of withdrawal of their January 15 proposal to exempt 84 medical device types – for which the normal regulatory process was temporarily waived or made more lenient during the COVID-19 public health emergency – from FDA’s 510(k) notification requirement. In its notice, FDA cited a “flawed” reliance by HHS, which issued the original notice, on FDA s Manufacturer and User Facility Device Experience (MAUDE) database for adverse event reporting. However, this withdrawal does not override the January 15 exemptions for seven class I medical devices, all of which were gloves.
By Shereen Hashem
Apr 16, 2021
OSHA has extended its comment period for the proposed rule to update the agency’s Hazard Communication Standard (HCS) to May 19, 2021, according to a press release.
OSHA published a Federal Register Notice to extend the submission of public comments by 30 days to allow stakeholders interested in the proposition the time needed to collect information and data necessary for comment. OSHA expects the HCS update will increase worker safety and protection, reduce chemical-related incidence, occupational illnesses and injuries by improving information on Safety Data Sheets and labels for hazardous chemicals.
The hazard classification aspect would provide specific criteria for classification. Labels would be required to include a harmonized signal word, pictogram and hazard statement for each hazard class and category.
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As we explained in a previous alert, one of the lesser-known provisions of the March 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act was a significant overhaul of the way that most OTC drugs are regulated in the United States.
In order to support the new FDA review process for OTC monograph drugs, the CARES Act also established a new user fee system, which, among other things, requires owners and operators of facilities engaged in the manufacturing or processing of OTC monograph drugs to begin paying annual “facility fees.” On March 25, 2021, FDA published a Federal Register Notice in which the agency finally announced the amounts of the first annual OTC drug facility fees (for FY 2021), which are as follows:
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