Information, Management, Manufacturing and Specialization

It’s the Law Now –Cybersecurity Information in Premarket Submissions

FDA Law

APRIL 25, 2023

Shapiro — Does your firm manufacture a “cyber device”? The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. Congress has given FDA the authority to require device manufacturers to provide cybersecurity information in their premarket submissions for a “cyber device.”

Specialization

Specialization Provider Medical Manufacturing

Small Change: FDA’s Final Predetermined Change Control Plan (PCCP) Guidance Ditches ML and Adds Some Details, But Otherwise Sticks Closely to the Draft

FDA Law

FEBRUARY 13, 2025

The guidance encourages sponsors to engage with FDA using the Q-Submission Program prior to submitting a PCCP in order to obtain FDA feedback on if the proposed modification is suitable for inclusion in a PCCP and what information the PCCP will need to include. FDA recommends including only a limited number of modifications in the PCCP.

Manufacturing

Manufacturing Management Specialization Provider

New DS Core Features - General and Core Plan

CDOCS

FEBRUARY 14, 2025

png]</p> <h3><span style="font-size:14px"><strong>Bulk Download of Patient Files</strong></span></h3> <p><span style="font-size:12px">Managing& patient data is now easier with bulk download functionality.

Management

Management Manufacturing Patients Specialization

Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions

FDA Law

MAY 8, 2023

The discussion paper described a PCCP as including (1) the types of anticipated modifications (SaMD Pre-Specifications or SPS) based on the retraining and model update strategy and (2) the associated methodology (Algorithm Change Protocol or ACP) being used to implement those changes in a controlled manner to manage patient risks.

Manufacturing

Manufacturing Provider Medical IT

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 1)

FDA Law

MAY 3, 2021

Maintaining complete and accurate records with direct, ongoing oversight by management reduces risk of internal employee pilferage and maximizes potential for early detection should diversion occur. Granted COVID has impacted regular DEA inspection schedules for most local DEA offices, but that is likely to change in the coming months.

Management

Management Manufacturing Specialization IT

Well Isn’t that Special: An Assessment of the Special Control Associated with Simple Point of Care COVID-19 Antigen Tests

FDA Law

MAY 19, 2023

In this blog we examine the Special Controls put in place to mitigate false results, incorrect interpretation of results, and incorrect operation of the device. The Special Controls are silent on what would constitute appropriate levels of evidence necessary to satisfy this criterion. analytical, clinical and stability).

Specialization

Specialization Clinic Provider IT

FDA’s Pre-Cert Pilot Ends. Will there be a Sequel?

FDA Law

OCTOBER 31, 2022

It seems that FDA may have validated that, even with an Excellence Appraisal above and beyond standard compliance with good manufacturing practices, there is a need for pre-market review for Class 2 devices. Despite the limitations in testing, some of the findings were noteworthy.

Manufacturing

Manufacturing Specialization Management IT

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 1)

FDA Law

MAY 3, 2021

Maintaining complete and accurate records with direct, ongoing oversight by management reduces risk of internal employee pilferage and maximizes potential for early detection should diversion occur. Granted COVID has impacted regular DEA inspection schedules for most local DEA offices, but that is likely to change in the coming months.

Management

Management Manufacturing Specialization IT

ACI To Host Multiple Events Featuring HP&M Speakers – Discounts Available to FDA Law Blog Readers

FDA Law

MARCH 6, 2024

More information about the conference can be found here. For complete information on the conference, click here. Kurt provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. S for reduced registration fees.

Management

Management Manufacturing Government Specialization

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

FDA Law

MAY 20, 2021

We are providing a post in three parts on cyclic and on-site inspections in which we focus on the background of inspections, how investigators conduct them, and how registrants should proactively prepare for and manage them. Registrants may withhold consent or, if given, can withdraw consent at any time.

Management

Management Consulting Provider Physicals

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

FDA Law

MAY 20, 2021

We are providing a post in three parts on cyclic and on-site inspections in which we focus on the background of inspections, how investigators conduct them, and how registrants should proactively prepare for and manage them. Registrants may withhold consent or, if given, can withdraw consent at any time.

Management

Management Consulting Provider Physicals

New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

FDA Law

NOVEMBER 20, 2024

Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. The draft guidance provides recommendations for collection and reporting of chemical characterization data and discusses the topics of information gathering, test article extraction, chemical analysis, and data reporting.

Provider

Provider Medical Manufacturing Consulting

The New FDA Draft Human Factors Guidance: A Bridge Too Far

FDA Law

FEBRUARY 22, 2023

In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. Now FDA has issued a draft guidance , Content of Human Factors Information in Medical Device Marketing Submissions (Dec.

Manufacturing

Manufacturing Engineering Medical IT

(Slightly More) Options for cGMP for Combination Products: FDA Describes Alternative or Streamlined Mechanisms for Compliance

FDA Law

SEPTEMBER 26, 2022

Brevig, Senior Regulatory Device and Biologics Exper — FDA recently published Alternative or Streamlined Mechanisms for Complying with the Current Good Manufacturing Practice Requirements for Combination Products; List under the 21st Century Cures Act in the Federal Register (FR Notice). By way of background, 21 C.F.R. § 21 C.F.R. §

Manufacturing

Manufacturing Specialization Provider Medical

CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

FDA Law

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028.

Manufacturing

Manufacturing Provider IT Electronics

An Arm and a Leg: The Prescription Drug Playbook, Part I

Physician's Weekly

JUNE 19, 2025

This is the kind of information we all need, all deserve. Back in February, we asked you, our listeners, to tell us how you’ve managed when your prescriptions got really expensive. Like I’m having to go outside of that in order to get them the medications that are nothing special. It was denied.’ Dan: I KNOW!

Insurance

Insurance IT Board-Certified Medical

Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

GeriPal

MAY 8, 2025

So in our trial, because of security reasons, we are required by Health Canada to store the substance in a special secure area in my office. Alex 06:03 Is psilocybin that’s used for medicinal purposes in your studies, for example, is that manufactured or is it derived directly from mushrooms? James 01:34 Yeah, right on.

Illness

Illness IT Patient-Centered Patients

Aging and Climate Change: Karl Pillemer, Leslie Wharton, & Ruth McDermott-Levy

GeriPal

DECEMBER 7, 2023

I actually wonder though, since we’re on a GeriPal broadcast, I think that people are under emphasizing the special risk of older people. Its major goal is to try to pull together information on aging and climate change for three groups. What’s our role in changing the healthcare system, in our own healthcare system.

Healthcare

Healthcare IT Education Community

Primary Care Digest

It’s the Law Now –Cybersecurity Information in Premarket Submissions

Small Change: FDA’s Final Predetermined Change Control Plan (PCCP) Guidance Ditches ML and Adds Some Details, But Otherwise Sticks Closely to the Draft

Trending Sources

New DS Core Features - General and Core Plan

Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 1)

Well Isn’t that Special: An Assessment of the Special Control Associated with Simple Point of Care COVID-19 Antigen Tests

FDA’s Pre-Cert Pilot Ends. Will there be a Sequel?

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 1)

ACI To Host Multiple Events Featuring HP&M Speakers – Discounts Available to FDA Law Blog Readers

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

The New FDA Draft Human Factors Guidance: A Bridge Too Far

(Slightly More) Options for cGMP for Combination Products: FDA Describes Alternative or Streamlined Mechanisms for Compliance

CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

An Arm and a Leg: The Prescription Drug Playbook, Part I

Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

Aging and Climate Change: Karl Pillemer, Leslie Wharton, & Ruth McDermott-Levy

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