Health Populi

AUGUST 2, 2022

In the meantime, the FDA has received at least 2 million adverse events each year since 2018, which contribute to less-optimal patient outcomes — or, in the worst cases, deaths. For patients to fully engaged with medicines in their treatment and self-care, trust must be embedded across these three categories (and others along the way).

COVID-19 62

COVID-19 FDA Health Outcomes 62

Health Populi

JANUARY 31, 2018

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. Omron seeks to jump that hurdle through FDA clearance.

FDA 81

FDA Doctors Public Health Medicare 81

Dot Compliance

FEBRUARY 8, 2022

To determine whether a particular software falls under the category of SaMD or whether it is considered a member of one of the three other subclasses, two questions must be answered: Does the software provide a direct medical benefit when used (correctly), and can it place the patient at risk if it is used incorrectly or malfunctions?

FDA 52

FDA Compliance 52

Health Populi

JANUARY 9, 2019

Consider a 2016 Aflac survey asking consumers what their ideal health insurance shopping experience should feel like. Both of these companies have innovated new-new things for hearing, via over-the-counter channels, and for dealing with pain, via an FDA-cleared device that a person in pain can buy via many retail channels.

Health Insurance 89

Health Insurance FDA 89

SQA

OCTOBER 18, 2022

Policymakers, regulators, and legislators should not make any decisions that impact consumers’ access to FDA-approved sunscreen UV filters until the scientific community reaches an informed consensus. United States Food and Drug Administration (FDA) – Regulations and Guidances. PDA Technical Report No.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 Compliance 40

Health Populi

JANUARY 10, 2020

In Valencell’s recent survey of consumer wearable preferences , 55% of people said they’d like to monitor blood pressure, up from 46% in 2016 as shown in this bar chart from the study. One in two people would like to monitor stress and heart health, and 33% would like to monitor blood glucose levels.

Doctors 88

Doctors Health Insurance FDA 88

HIT Consultant

JUNE 29, 2023

The community category included ambassador programs and work with community advisors. It begs the question: how do we ultimately achieve full representation and ensure accountability to uphold the promises we have made for patients?

FDA 98

FDA Governance 98

Drug & Device Law

JANUARY 9, 2023

555 (2009), a prescription drug preemption case, despite the relevant drug(s) being over-the-counter (“OTC”), and thus approved under an entirely different FDA regulatory process. 26, 2016), earning that case a place on our 2016 “worst case” list. Levine , 555 U.S. 2022 WL 17348351, at *4. Albrecht , 139 S. 2019), and Levine.

FDA 59

FDA Governance Nurses 59

Drug & Device Law

APRIL 18, 2022

2016), “ Probably the Best Wisconsin Law Decision We’ve Ever Seen.” make clear that Wisconsin adopts the doctrine, as consistently predicted by Wisconsin federal courts since 2016. at *3 – which means, as we’ve discussed before , a manufacturer cannot include warnings about such off-label uses absent specific FDA approval.

FDA 59

FDA 59

Drug & Device Law

OCTOBER 7, 2022

One particular “permanent” implantable contraceptive device has been the subject of litigation for years, even though it was approved by FDA as a class III device. (Our What risk is acceptable for a device in a high risk category (i.e., 1938 (2016), but the lack of a presumption meant plaintiff’s claim was preempted.

FDA 59

FDA Fraud Doctors Public Health 59

Drug & Device Law

JANUARY 30, 2023

470 (1996), was decided – removing express preemption as a defense for manufacturers of §510(k) products So defendants moved on fraud on the FDA under an implied preemption theory and won. Plaintiffs Legal Committee , 531 U.S. Mensing , 564 U.S. Mensing , 564 U.S. Lohr , 518 U.S.

FDA 72

FDA Fraud Governance Medicare 72

Drug & Device Law

NOVEMBER 15, 2022

Plaintiff’s claims break down into three categories—design defect, failure to warn, and failure to monitor. So, the case boils down to failure to warn which itself had two sub-categories—failure to warn based on product labeling and failure to warn based on failure to report adverse events. Korlym was approved by the FDA in 2012.

FDA 104

FDA 104

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 FDA reviewed the notices but did not then have to grant permission before the device could be sold.

FDA 59

FDA Hospitals 59