FDA Law Blog

JUNE 21, 2023

Cato — On June 1, CDRH announced that it is seeking public comment on questions regarding how CDRH can facilitate access to medical technologies designed for use outside of traditional clinical settings, particularly in the home. What medical technologies could be ideal to transition to use in non-clinical settings?

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Medical Patients Healthcare Electronics 45

FDA Law Blog

JULY 10, 2023

In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. However, the strategy of addressing the AI request presented in the next section of this blog post applies to all three types of 510(k)s. FDA Day (in calendar days) FDA Actions Day 1 FDA receives 510(k) submission.

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Provider IT Engineering Medical 75

FDA Law Blog

SEPTEMBER 27, 2023

The sponsor needs to have selected a specific investigational product or have a product-derivation strategy to evaluate in a clinical study before requesting an INTERACT study. Like with Type D meetings (and Type A meetings and Type C meetings about a novel surrogate endpoint), the meeting package should be included with the meeting request.

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IT Provider Manufacturing Clinic 64

GeriPal

FEBRUARY 29, 2024

But when we have people in rural areas of California, so we don’t know our clinical site, we go from San Francisco all the way to the Northern California border, super rural areas. I actually wrote a blog post about this when we were a blog. We were a blog? But I remember having a conversation with them.

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IT Patient-Centered Illness Education 126

FDA Law Blog

JULY 7, 2024

The guidance restates the central premise of the final rule, i.e., that LDTs are medical devices and the clinical laboratories that design, manufacture and use them to test patient specimens are manufacturers. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R. 820.198). .

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Manufacturing Provider Physicals Electronics 64

GeriPal

DECEMBER 8, 2022

Integration of Person-Centered Narratives Into the Electronic Health Record: Study Protocol. Connection — The Integration of a Person-Centered Narrative Intervention into the Electronic Health Record : An implementation study. Eric’s blog post on Dignity Therapy from 2011. Bennett, C.R., Schilling, L., Doorenbos, A.

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Patient-Centered Illness Healthcare IT 115

PEMBlog

MARCH 27, 2024

She is a member of the Clinical Genome Resource Inborn Errors of Metabolism (IEM) Clinical Domain Working Group, where as a biocurator she assesses the pathogenicity of variants in IEM-associated genes to facilitate expedited genetic diagnosis for IEMs. And not all IEMs are included on NBS, NBS can miss individuals with IEMs.

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Consulting Individual Families Family 59

GeriPal

DECEMBER 15, 2022

And then we also have another Vas, many of the interviews are done by medical students or other healthcare trainees as part of their clinical rotation at the VA. And so mine is here at the University of Colorado system, so a non-VA system, so different electronic health records, we have Epic. I was successful and had funding.

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IT Patient-Centered Healthcare Illness 105

FDA Law Blog

JANUARY 8, 2023

If a researcher wishes to change those research elements, they must notify DEA via registered mail or electronically within 30 days before implementation. If a change of cannabis quantity does not impact other factors, researchers must notify DEA by registered mail or electronically and the agency must respond within 3 days.

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Medical Manufacturing Electronics Provider 64

GeriPal

SEPTEMBER 19, 2024

Eric 07:31 A clinical perspective, why is it important to test this stepped care model versus implementing more? And now when I think about the clinic at Duke, when we’re really running on all cylinders, we can get ourselves up to a five, six, seven week wait for a new palliative care referral. This is Eric Widera.

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Patient-Centered IT Patients Hospital 119