FDA Law Blog

NOVEMBER 20, 2024

Chemical characterization identifies and quantifies chemicals that may be released from the medical device, while a toxicological risk analysis (TRA) evaluates the risks to the patient associated with the chemicals identified. Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device.

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Provider Medical Manufacturing Consulting 59

FDA Law Blog

OCTOBER 10, 2023

Performance data should be customized to the indications for use, including the specific intended patient population (adult vs. pediatric), disease state, conditions of use, and the target anatomical location. In cases where devices are expected to be frequently replaced, testing should be guided by the aggregate patient exposure.

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Manufacturing Engineering Clinic Patients 45

FDA Law Blog

SEPTEMBER 20, 2021

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.

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Patient-Centered Manufacturing Clinic Provider 52

FDA Law Blog

FEBRUARY 1, 2022

FDA addressed each inquiry and responsive comments in turn, but the comments overall were similar—everyone has different ideas.

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Provider IT Consulting Manufacturing 52

FDA Law Blog

MARCH 20, 2022

Almost all recalls are conducted on a voluntary basis by the manufacturer. Manufacturers hope for the best that their products are going to be used safely and effectively for patients and consumers. It is critical for firms in a product distribution chain to be “recall ready.””.

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Electronics Manufacturing Provider IT 40

GeriPal

MAY 5, 2022

And so often we get consulted by teams that say, “I have this older patient and they’re pretty isolated and I think they have dementia. ” And similarly, today we saw patient in the ICU, critically ill, had some strokes, and the ICU team was saying, “He’s not interactive, less interactive.”

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IT Screening Hospital Clinic 102

FDA Law Blog

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. § 806) and Complaint Files (21 C.F.R.

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Manufacturing Provider Physicals Electronics 64

Physician's Weekly

JUNE 19, 2025

This is a, you know, board certified pediatric neurologist who’s been seeing this patient for years. But a lot of patients say, like Bob would: My doctors and I had already DONE all this checking. Dan: Another addition: Manufacturer coupons. Bea Bosco is our consulting director of operations. Bob: Seems unnecessary.

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Insurance IT Board-Certified Medical 52

GeriPal

MAY 8, 2025

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. Then fast forward a year.

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Illness IT Patient-Centered Patients 107

FDA Law Blog

JANUARY 8, 2023

Doctor-Patient Relationship. Also of great importance is the Act’s authorizing state-licensed physicians to advise patients or their legal guardians of the potential harms and benefits of cannabis derivatives as a medical treatment. Cannabis Manufacturer Registration for Research. 21 U.S.C. § Cannabis Researcher Registrations.

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Medical Manufacturing Electronics Provider 64

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.” The task force facilitates communication between device manufacturers and payors.

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Manufacturing Medical Appointment Patient-Centered 45

FDA Law Blog

AUGUST 21, 2023

After all, the labeling is intended to do exactly that: it informs patients and prescribers of the risks to ensure the product is used effectively and in a manner that mitigates risks, according to FDA’s understanding of the relevant science. FDA, in other words, directed, and continues to direct, pregnant women to a learned intermediary.

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Manufacturing Consulting Healthcare Professional Vaccination 40

FDA Law Blog

FEBRUARY 20, 2025

Interestingly, counsel focused his arguments exclusively on parrying legal attacks, rather than arguing why the rule was necessary to protect patients. That, of course, is not unique to labs with LDTs; kit manufacturers also need to obtain those insights well before they begin studies.)

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Patient-Centered Consulting Government Clinic 102