Health Law Advisor

MAY 3, 2022

In this month’s post, in the medical device realm I explore what kinds of inspection citations most often precede a warning letter. We have just gone through an extraordinary two years where, in unprecedented fashion, FDA’s inspection process was essentially shut down. Just a short while ago FDA recommenced inspections.

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Health Law Advisor

APRIL 5, 2022

This month’s post focuses on how timely FDA decisions are in categorizing new diagnostics under the Clinical Laboratory Improvements Amendments of 1988 (CLIA). I use the word “may” there because the FDA data set is inadequate to support a firm conclusion. of that guidance, and FDA refers to these as “concurrent.”

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Health Populi

JANUARY 31, 2018

In 2017, Hugh Langley wrote in Wareable that, “blood pressure is wearable tech’s next challenge.” Omron is submitting the HeartGuide watch for FDA review this year and once cleared, the device will be the first blood pressure monitor that accurately reads BP right from the wrist. according to the CDC.

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SQA

MAY 24, 2023

ANVISA Resumes Inspections in the Area of Technovigilance, 29 March 2023 In partnership with local Health Surveillance, ANVISA technical teams carried out in March 2023 two (2) medical device manufacturer inspections with an aim to strengthen the monitoring of these products in Brazil, ensuring their safety, performance, and quality.

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SQA

DECEMBER 16, 2022

ANVISA’s Questions & Answers (Q&A) on Medical Cannabis for Clinical Investigations, 14 September 2022. Brazil’s ANVISA Announces Major Medical Device Registration Updates, 16 September 2022. China: National Medical Products Administration (NMPA). 07 Medical Diagnostic and Monitoring Equipment.

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SQA

FEBRUARY 15, 2023

Following the draft consultation in November 2022, the NMPA announced the issuance of the Regulations on the Supervision and Management of Enterprises Implementing the Main Responsibility of the Quality and Safety of Medical Devices , which will come into force on 01 March 2023.

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Health Populi

JANUARY 9, 2019

who have health insurance must take on a deductible of some amount, which compels that insured individual to spend the first dollar on medical services up until they meet their financial commitment. By 2017, these costs were $11 on average for a generic, $33 for a brand on the approved list, and $59 for a third-tier brand off the formulary.

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Bill of Health

APRIL 4, 2024

Introduction: A Fragmented AI in Healthcare Regulatory Landscape In the past few years, we have witnessed a surge in artificial intelligence-related research and diagnostics in the medical field. FDA has struggled with how to regulate adaptive rather than locked algorithms. Sectoral US Laws In the U.S., The sectorialism of the U.S.

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Kaiser Health News

JANUARY 12, 2023

15 close, a record number of people have signed up, taking advantage of renewed subsidies and other help with medical costs. On one hand, the FDA has relaxed some of the risk evaluation and mitigation strategies (REMS) from the prescribing rules surrounding abortion pills. It stands for risk evaluation and mitigation strategy.

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Kaiser Health News

FEBRUARY 9, 2023

Meanwhile, abortion rights advocates and opponents are anxiously awaiting a federal court decision out of Texas that could result in a nationwide ban on mifepristone, one of two drugs used in medication abortion. Rovner: Sarah, is the FDA worried about this case? So that really jumped out at me in the speech as well.

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Health Populi

JANUARY 2, 2020

Next week, the Consumer Technology Association (CTA) will convene CES, the Consumer Electronics Show, where over 180,000 tech-minded people from around the world will convene to kick the tires on new TVs, games, smart home devices, 5G connections, 3-D printing, drones, and to be sure, digital health innovations.

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Drug & Device Law

AUGUST 22, 2022

The plaintiff in Jacob sued the manufacturer of a Class III, FDA premarket-approved medical device. First, the plaintiff’s non-parallel claims were “preempted to the extent” that they would have imposed “alleged labeling or manufacturing requirements that are different from, or in addition to, those imposed by the FDA.”

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Drug & Device Law

SEPTEMBER 9, 2022

470 (1996), has nothing useful to say about the FDA’s current system for clearing medical devices. FDA: A Lesson from Pelvic Mesh Litigation on Relative Competence to Decide a Legal Question,” 76 Food & Drug L.J. The device classification process is something Congress took seriously. Lohr , 518 U.S.

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