FDA Law

JULY 7, 2021

Gibbs — In the first challenge ever brought against FDA’s rarely used power to ban a medical device, a court found FDA overstepped its authority and overturned the ban. In 2018, a Massachusetts court upheld the use of GEDs in treating patients with SIB/AB, finding the device to be effective in treating refractory patients.

Medical 52

Medical Patient-Centered Patients IT 52

FDA Law

SEPTEMBER 11, 2023

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

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Medical Electronics Manufacturing Utilities 64

FDA Law

NOVEMBER 9, 2021

Lenz, Senior Medical Device Regulation Expert — FDA introduced electronic copies (eCopies) of 510(k)s in 2013 (see our prior blogs here and here ) as a way to reduce the need for submission of paper copies of 510(k)s to the Agency. This pilot program, which utilized FDA’s eSubmitter electronic submission template, ended in May 2021.

Electronics 40

Electronics Physicals Provider Utilities 40

FDA Law

SEPTEMBER 26, 2022

Lenz, Principal Medical Device Regulation Expert & Holly N. requires generally that manufacturing of a combination product (CP) must comply with the applicable current Good Manufacturing Practice regulations (cGMPs) for all of its components ( i.e., a drug/device CP must follow the cGMPs for drugs as well as those for medical devices).

Manufacturing 40

Manufacturing Specialization Provider Medical 40

FDA Law

JULY 10, 2023

Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. By Philip Won & Adrienne R.

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Provider IT Engineering Medical 75

FDA Law

DECEMBER 18, 2022

Mullen — On December 9, 2022, FDA issued a draft guidance document on the Voluntary Malfunction Summary Reporting (VMSR) Program for medical devices. Then, in 2016, FDA noted its goal to streamline MDR requirements in the Medical Device User Fee Amendments of 2017 (MDUFA IV) commitment letter. April 1 – June 30. July 1 – September 30.

Medical 59

Medical Manufacturing Individual Provider 59

GeriPal

JULY 21, 2022

Eric: For those of you don’t know, Emmy was on our podcast back in 2018 … man, pre-COVID times. Emmy: But we know that physiologic changes with aging, like decreasing night vision and so forth, as well as medications, as well as medical conditions, can all affect whether you can drive. Weren’t those the days?

IT 102

IT Families Family Diagnosis 102

GeriPal

SEPTEMBER 7, 2023

William: So ASCO decided to make a high priority this year to redo the guidelines, which were originally released in 2018. So pretty soon, I hope, we’ll be able to do this all electronically by anyone who wants to. He had a very aggressive lymphoma, highly aggressive, with a lot of different medical conditions.

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Patient-Centered IT Patients Clinic 129

FDA Law

JUNE 10, 2025

One commenter, without providing details, asserted that the chemical may have uses in the medical field. Public comments must be submitted electronically or postmarked on or before July 3, 2025. and lacks accepted safety for use under medical supervision, the criteria for schedule I placement. 23,477 (June 3, 2025).

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Specialization Manufacturing Electronics PCP 69

GeriPal

JULY 13, 2023

Summary Transcript Summary Today’s podcast is a follow up to our 2018 podcast with Randy Curtis about the Jumpstart intervention. I wonder if we can just start off just going back a little bit because we had Randy on back in 2018 talking about Jumpstart, priming patients to do goals of care conversations. Am I summarizing that right?

Patient-Centered 83

Patient-Centered IT Patients Hospital 83

GeriPal

MARCH 27, 2025

But most people with dementia are initially diagnosed and medically managed in primary care, and they really desire clinicians to initiate these conversations but there are a number of really important barriers for these conversations taking place. Sydney 22:01 Well, it’s what’s in the electronic health record.

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Primary Care IT Clinic Patient-Centered 79

GeriPal

FEBRUARY 24, 2022

And so the definition of advance care planning really switched in, I think, 2017, 2018, there was kind of a United States definition and then an international consensus definition. And then you can make a medical recommendation that matches with what they’ve told you. What are your values? You have to hear what they understand.

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Illness Patient-Centered IT Patients 98

Physician's Weekly

JUNE 25, 2025

Dozens of insurance companies, including Cigna, Aetna, Humana, and UnitedHealthcare, agreed to several measures, which include making fewer medical procedures subject to prior authorization and speeding up the review process. Insurers also pledged that medical professionals would continue to review prior authorization denials.

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Insurance Patient-Centered Patients Government 52

Physician's Weekly

JUNE 17, 2025

But that’s when his family began fighting another adversary: their health insurer, which decided the treatment was “not medically necessary,” according to insurance paperwork. Prior authorization mostly happens behind the scenes, almost always electronically, and nearly all requests are quickly, or even instantly, approved.

Insurance 52

Insurance Patients Behavioral Health Services Diagnose 52

Physicians News Digest

APRIL 3, 2025

Survey data gathered by AHRQ provides much of what is known about hospitalizations for motor accidents, measles, methamphetamine, and thousands of other medical issues. Medical errors caused by missed diagnoses, drug errors, hospital infections, and other factors kill and maim tens of thousands of Americans each year.

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Patient-Centered Hospital Diagnose Medical 52