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CMS Proposes Minimum Staffing Requirements and Enhanced Facility Assessments for Nursing Homes

C&M Health Law

Department of Health and Human Services, through the Centers for Medicare & Medicaid Services (“CMS”) issued a much anticipated and contested proposed rule that seeks to establish minimum staffing level requirements for nursing homes. hours of nursing staff per resident per day, or 3.0 HPRD from registered nurses (RNs) and 2.45

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Healthcare & Life Sciences Private Equity Deal Tracker: One Equity Acquires Prime Time Healthcare

McGuire Wood

Founded in 2012, the company states that it provides placement services for registered nurses, licensed practical nurses, certified nursing assistants and allied health clinicians to approximately 8,500 U.S. Founded in 2001 and spun out of J.P. facilities.

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SQA Regulatory Surveillance Summary | Monthly Update 2022 – June

SQA

The new guidance from the European Medical Device Coordination Group (MDCG) covers “borderline products” not easily categorized either as medical devices falling under MDR requirements or medical products for human use falling under Directive 2001/83/EC (MPD) requirements for CE Marking.

FDA 91
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SQA Regulatory Surveillance Summary | Monthly Update 2022 – Spring

SQA

Requirements for classification and related issues established under RDC 185/2001, as well as other relevant medical device regulations, will apply for SaMD, as well. The Points is an upgraded version of Practice for Cosmetics Production Licensing , implemented in 2016, with more stringent inspection requirements.

FDA 75
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FDA and Off-Label Communication – Getting Closer to Truth

Drug & Device Law

341 (2001)), calls “off-label use,” so we go with the majority naming convention. What the FDA calls, rather ponderously, “unapproved uses of approved/cleared medical products,” everybody else in the world (including the Supreme Court in Buckman Co. Plaintiffs Legal Committee , 531 U.S.

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