2001, Compliance and FDA - Health Care Compliance Brief

SQA Regulatory Surveillance Summary | Monthly Update 2022 – June

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

FDA COVID-19 Nursing Homes Public Health

SQA Regulatory Surveillance Summary | Monthly Update 2022 – Spring

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.

FDA

FDA Compliance Informed Consent Hospitals

SQA Regulatory Surveillance Summary | Monthly Update 2022 – September/October

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

FDA Compliance COVID-19 Licensing

Guest Post – Michigan Product Liability Law: Retroactivity of New Law and Primer

Drug & Device Law

FEBRUARY 15, 2024

As the DDL blog has previously reported , Michigan’s longstanding presumption of non-defectiveness applicable to FDA-approved drugs was recently repealed by the Michigan legislature in S.B. As this provision is newly applicable to FDA-approved products, it has not been tested by the courts on this issue. Lynch & Co. Flex Techs.,

FDA

FDA Fraud Compliance Hospitals

Contract Claim Based on Alleged FDCA Violation Held Not Impliedly Preempted

Drug & Device Law

JANUARY 23, 2024

Today’s case is a counterpart to our post a few months ago about a case applying Buckman preemption to a contract dispute where adjudicating the alleged breach would have forced the court to decide FDA regulatory issues. 4, 353 (2001). In that case ( Thogus Products Co. Bleep, LLC , 2023 WL 5607458 (N.D. 341, 349 n.4,

FDA

FDA Compliance Governance

Contract Claim Based on Alleged CGMP Violations Held Impliedly Preempted

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. 4, 353 (2001).

FDA

FDA Governance Compliance

Thinking About the FDA’s Alternative Summary Reporting Program

Drug & Device Law

SEPTEMBER 18, 2023

He came across several preemption decisions involving defendants who employed the FDA’s “alternative summary reporting” (“ASR”) system that the agency operated for about 20 years, “from 1997 through June 2019.” without adversely affecting FDA’s ability to monitor and react to such events. 18, 2022) ( available here ).

FDA

FDA Fraud Governance Compliance

Another Update on Medical Abortion Litigation

Drug & Device Law

SEPTEMBER 11, 2023

FDA litigation, back in April, the United States Supreme Court had just stayed what we described as “a truly ridiculous decision purporting to invalidate a number of actions taken by FDA with regard to mifepristone, the only currently marketed approved medication for medical abortion.” 341 (2001), is so important. FDA , 727 F.

FDA

FDA Doctors Malpractice COVID-19

Another Update on Medical Abortion Litigation

Drug & Device Law

AUGUST 28, 2023

FDA litigation, back in April, the United States Supreme Court had just stayed what we described as “a truly ridiculous decision purporting to invalidate a number of actions taken by FDA with regard to mifepristone, the only currently marketed approved medication for medical abortion.” 341 (2001), is so important. FDA , 727 F.

FDA

FDA Doctors Malpractice COVID-19

Logical Contradiction Doctrine: Buckman for Textualists

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. Plaintiffs Legal Committee , 531 U.S. Mensing , 564 U.S. Mensing , 564 U.S.

FDA

FDA Fraud Governance Medicare

Court Denies Motion to Dismiss Based on Implied Preemption

Drug & Device Law

OCTOBER 27, 2022

640.65, an FDA biologics regulation that requires entities that collect blood via a particular method to establish “donor identification system[s]” that “positively identifies each donor and relates such donor directly to his blood and its components as well as to his accumulated records and laboratory data.”. 341 (2001), the U.S.

FDA

FDA Licensing Compliance

510(k) Devices, Compliance Presumptions, and the Long Shadow of Lohr

Drug & Device Law

JUNE 9, 2022

In our initial post, we focused on the exception to the presumption, which allows liability to be imposed if a plaintiff alleges and ultimately proves that the defendant manufacturer committed fraud on the FDA. Today’s post focuses not on the exception to the compliance presumption but on the antecedent issue of when the presumption applies.

Compliance

Compliance FDA Fraud

Applying the Helpful but Problematic New Jersey Statute Creating a Rebuttable Compliance Presumption, the Third Circuit Affirms Dismissal of a Failure-to-Warn Claim

Drug & Device Law

MAY 5, 2022

2022), a short decision that came out the right way, but did so based on a problematic statute that creates a rebuttal presumption that warning labels approved by the FDA are adequate as a matter of state law. Stated differently, the rebuttal provision makes allegations and evidence of fraud on the FDA a prerequisite to state-law liability.

Compliance

Compliance FDA Fraud

Health Care Compliance Brief

SQA Regulatory Surveillance Summary | Monthly Update 2022 – June

SQA Regulatory Surveillance Summary | Monthly Update 2022 – Spring

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SQA Regulatory Surveillance Summary | Monthly Update 2022 – September/October

Guest Post – Michigan Product Liability Law: Retroactivity of New Law and Primer

Contract Claim Based on Alleged FDCA Violation Held Not Impliedly Preempted

Contract Claim Based on Alleged CGMP Violations Held Impliedly Preempted

Thinking About the FDA’s Alternative Summary Reporting Program

Another Update on Medical Abortion Litigation

Another Update on Medical Abortion Litigation

Logical Contradiction Doctrine: Buckman for Textualists

Court Denies Motion to Dismiss Based on Implied Preemption

510(k) Devices, Compliance Presumptions, and the Long Shadow of Lohr

Applying the Helpful but Problematic New Jersey Statute Creating a Rebuttable Compliance Presumption, the Third Circuit Affirms Dismissal of a Failure-to-Warn Claim

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