FDA Law Blog

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

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FDA Law Blog

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 The draft guidance provides recommendations for collection and reporting of chemical characterization data and discusses the topics of information gathering, test article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.

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CDOCS

MAY 4, 2021

Couple this with the in-office technologies of CEREC&reg; Primescan and CBCT allowed us to gain control of the technical processes necessary to manage and produce the surgical and restorative phases of treatment at one location.</span></p> We reviewed the 3D images together and discussed the risks associated with his case.

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Patient-Centered Patients Manufacturing Provider 52

FDA Law Blog

OCTOBER 10, 2023

Testing should be in line with the device’s intended duration of implantation, but FDA may consider whether testing results for a shorter duration can be extrapolated to provide information about long-term performance. We find that this information is noteworthy for manufacturers to consider.

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GeriPal

JUNE 20, 2024

It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. George 03:01 So I would say that as many clinical issues in older adults, we need to think about them in two ways. Eric 11:57 In, let’s say, my clinic. Eric 08:05 Yeah.

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IT Patient-Centered Patients Clinic 120

FDA Law Blog

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 Now FDA has issued a draft guidance , Content of Human Factors Information in Medical Device Marketing Submissions (Dec.

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FDA Law Blog

SEPTEMBER 20, 2021

requesting records in lieu of an inspection, use of information shared by trusted foreign regulatory partners). FDA will discuss the goals letter and field public comments, on September 28, 2021 (announcement here ), as well as a separate workshop on meetings management practices, which is to be held by July 30, 2024.

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Patient-Centered Manufacturing Clinic Provider 52

FDA Law Blog

JANUARY 5, 2025

In response to the proposed rule, approximately 200 comments were submitted to the docket, and a meeting took place among FDA, the White House Office of Management and Budget (OMB) and the Consumer Healthcare Products Association (CHPA). Further elaboration of FDAs view would be helpful.

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FDA Law Blog

DECEMBER 16, 2024

The guidance also addresses FDAs obligation to provide considerations on third party compensation, information sharing, and conflicts of interest. All proposals underwent an initial technical, clinical, commercial, and regulatory review before receiving funding and in-kind service support.

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Consulting Manufacturing Utilities Provider 52

FDA Law Blog

MAY 19, 2023

Final Release Criteria Special Controls Sponsors will need to provide the final manufacturing release criterion with evidence that lots released at the extremes of the specification will still meet the claimed device performance (i.e., analytical, clinical and stability).

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FDA Law Blog

MARCH 6, 2025

Both guidance documents recommend data management practices for collecting data for use in developing, tuning, and testing an artificial intelligence model and making changes to said model. FDA notes the use of data collected outside the U.S.

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FDA Law Blog

SEPTEMBER 30, 2024

CMS did not finalize the price verification survey, which would have required manufacturers of 10 costly drugs selected annually to provide clinical information as well as information on production, distribution, research, and marketing costs, revenue and profit, and ex-U.S. pricing, among other things.

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The Clinical Problem Solvers

NOVEMBER 6, 2023

Identify ways to navigate clinical interactions with patients while respecting them and affirming their experiences with food and fatness. Between the years 2019 and 2021, Harrison served as Associate Editor—and later as Managing Editor—of Wear Your Voice Magazine. is rooted in anti-Blackness. Williams-Forson and Da’Shaun L.

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Community Manufacturing Patients Medical 52

FDA Law Blog

OCTOBER 17, 2023

Non-Addictive Medical Products to Treat Pain or Addiction The SUPPORT Act ( Public Law 115-271 ) mandated that FDA issue a guidance document to provide information on how the Agency can apply section 515B of the FD&C Act to non-addictive medical products intended to treat pain or addiction.

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FDA Law Blog

JUNE 14, 2023

He highlighted the following key features of TAP: An Innovative Approach To provide proactive support and guidance to medical device manufacturers, FDA has introduced a new CDRH position known as the “TAP Advisor.” Review teams already appoint a lead reviewer to each submission and sometimes assign a project manager to an extensive project.

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Manufacturing Medical Patient-Centered Appointment 45

GeriPal

MAY 8, 2025

We’ll discuss three recent clinical trials involving patients with serious illness, joined by our guests James Downar , Ali John Zarrabi , and Margaret Ross. Alex 00:33 Our next guest is Margaret Ross, who’s a clinical psychologist and researcher at St. Dr. James, welcome to the GeriPal Podcast. James 00:32 Good afternoon.

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Illness IT Patient-Centered Patients 107

GeriPal

DECEMBER 7, 2023

AlexSmithMD Additional links: JAMA paper on clinical research risks, climate change, and health Geriatric medicine in the era of climate change Health Care Without Harm: [link] Practice Green Health: [link] Global Consortium for Climate and Health Education: [link] Transcript Eric: Welcome to the GeriPal podcast. Karl: Sure.

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Healthcare IT Education Community 129

FDA Law Blog

NOVEMBER 8, 2022

Fellow panelist, August Bencke Geyer, who serves as Deputy General Manager of the Medical Devices Office at ANVISA (Brazilian Health Regulatory Agency) expressed enthusiasm and indicated that Brazilian regulators are watching closely to see how the program unfolds. It’s an easy way to manage the transition.”.

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Medical Manufacturing Patient-Centered Provider 59

FDA Law Blog

SEPTEMBER 13, 2021

A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate.

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