SQA

FEBRUARY 15, 2023

Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. PCPC looks forward to working with the FDA and key stakeholders to implement this important legislation.

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

Health Law Advisor

OCTOBER 3, 2022

Over the spring and summer, I did a series of posts on extracting quality information from FDA enforcement initiatives like warning letters , recalls , and inspections. But obviously FDA enforcement actions are not the only potential sources of quality data that FDA maintains. OCCUPATION: NON-HEALTHCARE PROFESSIONAL.

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FDA 52

Health Populi

JANUARY 2, 2020

Hearables have been emerging at CES for a few years, and now vision will be a newer category to watch. (As Subsequently, ResMed joined with Dr. Oz to launch SleepScore Labs – an exhibitor at CES 2020 in the fast-growing sleep category at the Show. Forbes ran a column on CES 2020 discussing AI in hearing and vision.

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Kaiser Health News

MAY 13, 2022

The period-tracking app Cycles, which is owned by Swedish company Perigee, falls into this category. Take Apple, for example, which repeatedly resisted unlocking iPhones for law enforcement in high-profile cases like the 2015 San Bernardino shooting. It can depend on the company’s approach to subpoenas, she added.

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US Department of Health and Human Services HIPAA Governance Health Insurance 101

Drug & Device Law

APRIL 28, 2022

155 (2015), spelled out what makes a restriction on speech content-based and, thus, presumptively invalid. As we noted soon after Reed and since , these standards flow directly into whether and how FDA can restrict what drug and device manufacturers say about off-label use, the main recurring issue for these companies. at **36-37.

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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. Levine , 555 U.S. 2022 WL 17348351, at *4. The monograph system was reformed [in 2020]. 2022 WL 17348351, at *4 (citations omitted). Albrecht , 139 S.

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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.” 871 (9th Cir.

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Informed Consent FDA Doctors 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.

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FDA Fraud Governance Medicare 72

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.

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FDA Hospitals 59

Drug & Device Law

NOVEMBER 9, 2023

In addition to its recent revamp of its “§510(k)” substantial equivalence clearance process for medical devices, (see our post here ), the FDA has also been active with respect to off-label communications – another regulatory area of continuing interest to this Blog. FDA , 119 F. Caronia , 703 F.3d 3d 149 (2d Cir. 3d 196 (S.D.N.Y.

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