HIT Consultant

JANUARY 3, 2023

Founded in 2006 with a vision to help people live longer, healthier lives, Valencell’s proven inventions, sensor technology, and algorithms can be found in tens of millions of wearable and hearable devices, in over 90 products, for companies such as Samsung, Suunto, Bose, Jabra, Huawei, and Sony. Meeting Demands Under Pressure.

FDA 98

FDA Compliance 98

Innovaare Compliance

JANUARY 15, 2024

These changes mark a pivotal shift from its original structure in 2006. 6] A compound drug not approved by the FDA under a New Drug Application or Biological License Application does not meet the definition of an applicable drug and will not be eligible for Part D. Rebates from the selected drugs may change. Non-applicable drugs (i.e.,

Medicare 52

Medicare Medicare Compliance FDA 52

SQA

JUNE 10, 2021

The new regulation, RDC 478/2021 , repeals economic monitoring and reporting processes previously established under RDC 185/2006, and initially reduces the number of medical device types for which economic monitoring will be required. FDA plant inspection and pay $50 million in fines and forfeiture. 10 May 2021.

COVID-19 52

COVID-19 FDA COVID-19 Vaccine Compliance 52

SQA

AUGUST 2, 2021

ISO 10651-5:2006, Lung ventilators for medical use – Particular requirements for basic safety and essential performance – Part 5: Gas-powered emergency resuscitators. Led by the FDA and ASPR, the White House report and its recommendations ( report PDF ) have been accepted by President Biden. United States FDA – Guidances for Devices.

FDA 83

FDA COVID-19 Pharmaceutical Industry Hospitals 83

Drug & Device Law

FEBRUARY 15, 2024

As the DDL blog has previously reported , Michigan’s longstanding presumption of non-defectiveness applicable to FDA-approved drugs was recently repealed by the Michigan legislature in S.B. As this provision is newly applicable to FDA-approved products, it has not been tested by the courts on this issue. Auto Owners Ins.

FDA 52

FDA Fraud Compliance Hospitals 52

Drug & Device Law

MAY 4, 2023

2015), finally gave appellate recognition to the preemption of design defect claims for FDA-approved branded prescription drugs. FDA approved the drug with its particular formulation and the manufacturer could not have changed the formulation on its own. 2006), aff’d by equally divided court , 552 U.S. 3d 281 (6th Cir.

FDA 64

FDA Fraud Compliance 64

Drug & Device Law

MAY 5, 2022

2022), a short decision that came out the right way, but did so based on a problematic statute that creates a rebuttal presumption that warning labels approved by the FDA are adequate as a matter of state law. Stated differently, the rebuttal provision makes allegations and evidence of fraud on the FDA a prerequisite to state-law liability.

Compliance 52

Compliance FDA Fraud 52