GeriPal

MAY 5, 2022

Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? Screening for addressing hearing loss should be an integral part of what we do in geriatrics and palliative care, but it often is either a passing thought or completely ignored. I’m guessing not.

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IT Screening Hospital Clinic 102

FDA Law

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. We find that this information is noteworthy for manufacturers to consider.

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Manufacturing Engineering Clinic Provider 45

FDA Law

MAY 17, 2021

suited for, like back to work screening. Since when has FDA been authorized to to abjure premarket review of a medical device whenever it chooses to do so, other than pursuant to express regulations placing a device in Class I or II and designating it as 510(k) exempt? FDA has not followed that procedure for LDTs.

Manufacturing 52

Manufacturing IT Screening Medical 52

FDA Law

MAY 17, 2021

suited for, like back to work screening. Since when has FDA been authorized to to abjure premarket review of a medical device whenever it chooses to do so, other than pursuant to express regulations placing a device in Class I or II and designating it as 510(k) exempt? FDA has not followed that procedure for LDTs.

Manufacturing 40

Manufacturing IT Screening Medical 40

FDA Law

NOVEMBER 18, 2021

Rapid tests for COVID-19 are fast, inexpensive to manufacture, and a relatively easy method to detect the presence of an active SARS?CoV?2 A positive result, however, is treated as a screen. That is just another way of saying, however, that the rapid antigen tests are best positioned as a screening tool. Why is that?

Screening 98

Screening Manufacturing Healthcare IT 98

FDA Law

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 820.198). .

Manufacturing 64

Manufacturing Provider Physicals Electronics 64

FDA Law

FEBRUARY 22, 2022

The good news is that the NIH’s program is real and has been offering helpful assistance to manufacturers seeking to obtain Emergency Use Authorization (EUA) approval from FDA for OTC rapid antigen tests. The NIH screens manufacturers to ensure they have reputable tests already in use in other countries with good supporting test data.

Manufacturing 52

Manufacturing Screening Provider Clinic 52

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. So medication adjustments. James 00:32 Good afternoon.

Illness 107

Illness IT Patient-Centered Patients 107

Alabama Academy of Family Physicians

FEBRUARY 20, 2025

By Wes Stubblefield, MD, MPH, FAAP ADPH Medical Officer H5N1 influenza, or “bird flu,” is a type of influenza that was first discovered in the 1950s. Since 2016, HPAI H5N1 has been detected in wild birds in the United States during screening efforts by wildlife authorities. For the public, cautious monitoring is recommended.

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Patient-Centered Provider Manufacturing Screening 130

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. Ruth: Right. Ruth: Yeah.

Healthcare 129

Healthcare IT Education Community 129

FDA Law

NOVEMBER 8, 2022

By Véronique Li, Senior Medical Device Regulation Expert — At the latest MedTech conference held in Boston, MA from October 24-26, we heard from FDA officials and industry representatives on a range of topics. Below, we provide a snapshot of the three-day event: Update on the International Medical Device Regulators Forum (IMDRF).

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Manufacturing Medical Patient-Centered Provider 59