SQA

AUGUST 2, 2021

ISO5356-1:2015, Anesthetic and respiratory equipment – Conical connectors – Part 1: Cones and sockets. ISO 17510:2015, Medical devices – Sleep apnea breathing therapy – Masks and application accessories. Led by the FDA and ASPR, the White House report and its recommendations ( report PDF ) have been accepted by President Biden.

FDA 83

FDA COVID-19 Pharmaceutical Industry Hospitals 83

Drug & Device Law

SEPTEMBER 21, 2023

The parties’ contract required the supplier to deliver components that “meet FDA standards for medical devices.” The manufacturer claimed that the supplier breached the contract when it delivered components that, according to the manufacturer, violated the FDA’s Current Good Manufacturing Practices (CGMP) regulations. Ohio 2023).

FDA 59

FDA Governance Compliance 59

Drug & Device Law

DECEMBER 29, 2023

2023) (federal government may unilaterally obtain dismissal of FCA claims, and calling the constitutionality of the FCA’s private enforcement mechanism into question) ( here ); Quishenberry v. Further, the plaintiffs’ arguments were based on scientific standards “not utilized by the FDA,” and thus preempted. Polansky v. 3d 239 (Cal.

FDA 105

FDA US Department of Health and Human Services COVID-19 Informed Consent 105

Drug & Device Law

AUGUST 8, 2022

So if compliance with an industry standard is a defense, this plaintiff went a step further and sued the organizations that created the standards. Furthermore, trade associations often serve to assist the government in areas that it does not regulate. 2015 WL 6393869 (S.D. has no power to enforce compliance”), aff’d , 405 F.

Doctors 52

Doctors Fraud Licensing Compliance 52

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

DECEMBER 6, 2022

According to the FDA, nothing, and that’s why the court dismissed the putative class action in Beasley v. As it turns out, thanks to very specific language from both the FDA and Congress, neither could the presence of PHOs before 2018. Like with drugs, foods regulated by the FDA cannot be “adulterated.” Tootsie Roll Indus.

FDA 59

FDA Compliance Governance 59

Drug & Device Law

JULY 26, 2023

2018), holding (as discussed here ) that New Jersey multi-county mass-tort litigation will henceforth be governed exclusively by New Jersey law, no matter where the plaintiff resided. 2015 WL 5567578, at *6-7 (W.D.N.C. 22, 2015) (admitting §510(k) compliance in pelvic mesh case under North Carolina law). at 523-24.

Compliance 52

Compliance FDA Licensing Governance 52