2014 and FDA - Health Care Compliance Brief

FDA and Digital Health Regulation

Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act (Cures Act) (Draft).

FDA

FDA HIPAA Compliance

FDA and Digital Health Regulation

Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act (Cures Act) (Draft).

FDA

FDA HIPAA Compliance

FDA and Digital Health Regulation

Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act (Cures Act) (Draft).

FDA

FDA HIPAA Compliance

FDA and Digital Health Regulation

Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act (Cures Act) (Draft).

FDA

FDA HIPAA Compliance

FDA and Digital Health Regulation

Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act (Cures Act) (Draft).

FDA

FDA HIPAA Compliance

SQA Regulatory Surveillance Summary | Monthly Update 2023 – March And April

SQA

MAY 24, 2023

ANVISA Resumes Inspections in the Area of Technovigilance, 29 March 2023 In partnership with local Health Surveillance, ANVISA technical teams carried out in March 2023 two (2) medical device manufacturer inspections with an aim to strengthen the monitoring of these products in Brazil, ensuring their safety, performance, and quality.

FDA

FDA Licensing Governance Compliance

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

SQA

DECEMBER 16, 2022

ANVISA’s Questions & Answers (Q&A) on Medical Cannabis for Clinical Investigations, 14 September 2022. Brazil’s ANVISA Announces Major Medical Device Registration Updates, 16 September 2022. China: National Medical Products Administration (NMPA). 07 Medical Diagnostic and Monitoring Equipment.

FDA

FDA Compliance COVID-19 Licensing

FDA Oversight of AI Software Developed by Health Care Providers

Health Law Advisor

AUGUST 10, 2023

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. It’s important to understand that FDA regulation isn’t punitive in the sense that it’s only intended to apply to bad people.

FDA

FDA Licensing Hospitals Medicaid

SQA Regulatory Surveillance Summary | Monthly Update 2024

SQA

FEBRUARY 26, 2024

The products had been improperly regularized in ANVISA as cosmetics since they are indicated for injectable use, a form that is not authorized for this category of product. The purpose of the note is to clarify that products for invasive aesthetic treatments cannot be regularized in the category of cosmetics.

FDA

FDA Compliance COVID-19 Public Health

Unpacking Averages: Device Inspection Citations That Frequently Precede Warning Letters

Health Law Advisor

MAY 3, 2022

In this month’s post, in the medical device realm I explore what kinds of inspection citations most often precede a warning letter. We have just gone through an extraordinary two years where, in unprecedented fashion, FDA’s inspection process was essentially shut down. Just a short while ago FDA recommenced inspections.

FDA

FDA Compliance

Dealing with the Pennsylvania Supreme Court’s Non-Decision on Standards Compliance Evidence

Drug & Device Law

JANUARY 15, 2024

As we discussed at length in this post, since the 1940s, the Pennsylvania Supreme Court and other courts applying Pennsylvania law have refused to subject prescription medical products to strict liability. Neither Lewis nor Tincher involved prescription medical products, but rather what we describe as “things that go clank.”

Compliance

Compliance FDA Governance State Policy

Who Needs a Lawyer in the Eleventh Circuit?

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.”

Informed Consent

Informed Consent FDA Doctors

Health Care Compliance Brief

FDA and Digital Health Regulation

FDA and Digital Health Regulation

Trending Sources

FDA and Digital Health Regulation

FDA and Digital Health Regulation

FDA and Digital Health Regulation

SQA Regulatory Surveillance Summary | Monthly Update 2023 – March And April

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

FDA Oversight of AI Software Developed by Health Care Providers

SQA Regulatory Surveillance Summary | Monthly Update 2024

Unpacking Averages: Device Inspection Citations That Frequently Precede Warning Letters

Dealing with the Pennsylvania Supreme Court’s Non-Decision on Standards Compliance Evidence

Who Needs a Lawyer in the Eleventh Circuit?

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