HIT Consultant

JUNE 7, 2023

To be truly effective, once a protocol has been implemented, its utilization needs to be monitored for compliance and effectiveness. However, clinician variability in individual practice attitudes, experience, and knowledge can impede the implementation of a feeding strategy therefore, compliance monitoring is necessary to be truly effective.

Hospitals 98

Hospitals Compliance Electronic Medical Records Patient Satisfaction 98

SQA

MAY 17, 2022

Requirements for classification and related issues established under RDC 185/2001, as well as other relevant medical device regulations, will apply for SaMD, as well. China Regulatory Roundup: Latest Guidelines for Medical Device and IVD Compliance, 17 March 2022. operations into compliance with cGMP.

FDA 75

FDA Compliance Informed Consent Hospitals 75

SQA

DECEMBER 16, 2022

ANVISA announced major updates to its Resolution of the Collegiate Board of Directors (RDC) 185/2001. China’s Center for Medical Device Evaluation (CMDE) Update Compliance Guidelines and Recommended Paths for Clinical Evaluation Paths for Certain Medical Devices, 25 July 2022. Address gaps in existing compliance requirements.

FDA 40

FDA Compliance COVID-19 Licensing 40

SQA

SEPTEMBER 2, 2022

The new guidance from the European Medical Device Coordination Group (MDCG) covers “borderline products” not easily categorized either as medical devices falling under MDR requirements or medical products for human use falling under Directive 2001/83/EC (MPD) requirements for CE Marking.

FDA 91

FDA COVID-19 Nursing Homes Compliance 91

SQA

APRIL 30, 2021

In addition, considering the fact that one marketing authorization application is submitted in accordance with Article 8(3) of Directive 2001/83/EC and the other marketing authorization application is submitted under an abridged procedure (e.g., European Medicines Agency (EMA) – Biologics.

COVID-19 Vaccine 52

COVID-19 Vaccine COVID-19 Compliance Governance 52

Drug & Device Law

AUGUST 28, 2023

341 (2001), is so important. If the laughably low standing standards permitted in Hippo III are, in fact, the law, then our side’s ability to assert preemption, compliance, and other defenses that presuppose the validity of FDA decisions will be threatened. That’s why Buckman Co. Plaintiffs Legal Committee , 531 U.S.

FDA 52

FDA Doctors Malpractice COVID-19 52

Drug & Device Law

SEPTEMBER 11, 2023

341 (2001), is so important. If the laughably low standing standards permitted in Hippo III are, in fact, the law, then our side’s ability to assert preemption, compliance, and other defenses that presuppose the validity of FDA decisions will be threatened. That’s why Buckman Co. Plaintiffs Legal Committee , 531 U.S.

FDA 59

FDA Doctors Malpractice COVID-19 59

Drug & Device Law

JULY 31, 2023

2001); Isham v. 2001), relied on these other statutes to hold that a road could not be a “product”). 2001) (applying Illinois law); Serpico v. Huntington Ingalls Inc. , 3d 1170, 1173 (9th Cir. 2016) (citations omitted). Accord Stark v. Armstrong World Industries, Inc. , 371, 377 (6th Cir. PADI Worldwide Corp. Engelhardt v.

Governance 52

Governance Payment Systems Hospitals Licensing 52

Drug & Device Law

SEPTEMBER 21, 2023

337(a) bars enforcement of a private contract that requires compliance with the FDCA. 4, 353 (2001). 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. Buckman Co. 341, 349 n.4,

FDA 59

FDA Governance Compliance 59

Drug & Device Law

JANUARY 30, 2023

341 (2001), with the rejection of the so-called “purposes and objectives” prong of implied preemption by the most conservative justices (at least in terms of federalism) on the Court. Plaintiffs Legal Committee , 531 U.S. Plaintiffs Legal Committee , 531 U.S. Dow Agrosciences LLC , 544 U.S.

FDA 72

FDA Fraud Governance Medicare 72

Drug & Device Law

OCTOBER 27, 2022

341 (2001), the U.S. The FDA’s statement that it was “not specif[ying] the means” of compliance was made in response to a public comment on the rule as proposed by the agency. 2d 808, 812 (E.D. 2013); Heisner v. Genzyme Corp. 2010 WL 894054 (N.D. Heck, in Buckman Co. Plaintiffs’ Legal Comm. ,

FDA 59

FDA Licensing Compliance 59

Drug & Device Law

SEPTEMBER 18, 2023

But what if the manufacturer allegedly failed to make its reports in compliance with the FDA’s restrictions on what types of adverse events were subject to ASR reporting? 341 (2001). Those are the allegations that we see in cases like Bell , 2023 WL 3006175, at *6, and Gravitt , 2022 WL 17668486, at *3. at 353.

FDA 59

FDA Fraud Governance Compliance 59

Drug & Device Law

FEBRUARY 15, 2024

Retroactivity: Intent of the Legislature and Creation of a New Duty The Michigan Supreme Court held that legislative intent is the “primary and overriding factor” to determine retroactivity. Lynch & Co. Flex Techs., 2d 180, 182 (Mich. Nothing about retroactivity. 2946(4).

FDA 52

FDA Compliance Fraud Hospitals 52

Drug & Device Law

JANUARY 23, 2024

Ohio 2023)), the question the court would have had to decide was whether a product was manufactured in compliance with the FDA’s Current Good Manufacturing Practices (CGMP) regulations. After several alleged violations, plaintiff entered into a Voluntary Compliance agreement with the State to bring itself into compliance.

FDA 52

FDA Compliance Governance 52

Drug & Device Law

MAY 5, 2022

341 (2001), which concluded that fraud-on-the-FDA claims are impliedly preempted because they “inevitably conflict” with the FDA’s regulatory discretion under. 2004), that provisions allowing the rebuttal of a compliance presumption based on alleged fraud on the FDA are preempted unless the FDA itself finds fraud. 21 U.S.C. §

Compliance 52

Compliance FDA Fraud 52

Drug & Device Law

JUNE 9, 2022

341 (2001), which concluded that fraud-on-the-FDA claims are impliedly preempted because they “inevitably conflict” with the FDA’s regulatory discretion under 21 U.S.C. § Today’s post focuses not on the exception to the compliance presumption but on the antecedent issue of when the presumption applies. Boston Scientific Corp.

Compliance 59

Compliance FDA Fraud 59