FDA Law Blog

FEBRUARY 28, 2022

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ). The Guidance provides practical advice for device manufacturers to utilize patient engagement in clinical studies.

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Patients Clinic Medical Patient-Centered 52

FDA Law Blog

JUNE 27, 2023

By Véronique Li, Senior Medical Device Regulation Expert & Anne K. Walsh — Last fall, we blogged about the process FDA uses to review allegations of regulatory misconduct against device manufacturers, suggesting greater transparency on the FDA process was needed (see here ).

Manufacturing 59

Manufacturing Utilities Electronics IT 59

CDOCS

MAY 4, 2021

Intra-oral photographs were taken and after reviewing his medical history we discussed his desires for a fixed replacement of these teeth. He presented with a high smile line and desired fixed natural appearing teeth. I utilized 2CC of the mineralized freeze-dried allograft, particle size 500um to 1000um.

Patient-Centered 52

Patient-Centered Patients Manufacturing Provider 52

FDA Law Blog

OCTOBER 14, 2021

As a scientific/medical matter, there are many variables beside the RAS device that are responsible for clinical outcomes. Given these onerous requirements, it is not a surprise that RAS device manufacturers have not sought clearance for RAS devices for oncology procedures. But these devices are not independent cancer therapeutics.

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Patient-Centered Healthcare Manufacturing Provider 52

FDA Law Blog

DECEMBER 11, 2023

6] It is inconsistent to say that LDTs must be regulated as medical devices because of the newness of the tests and then reduce the cost of the proposed regulation by declaring that half of all LDTs will be exempt from premarket review. FDA, Performance Report to Congress: Medical Device User Fee Amendments FY 2022, at 13-18, [link]. [14]

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IT Medical Patient-Centered Provider 69

FDA Law Blog

MARCH 20, 2022

Baumhardt, Senior Medical Device Regulation Expert & Anne K. Almost all recalls are conducted on a voluntary basis by the manufacturer. FDA has model recall communication templates available here that firms can utilize. By Philip Won & Lisa M. The saying “Hope for the best, prepare for the worst” applies to recalls.

Electronics 40

Electronics Manufacturing Provider IT 40

FDA Law Blog

SEPTEMBER 20, 2021

As such, we present these programs and initiatives roughly in order of the newest and most substantial changes to more minor. STAR aims to facilitate earlier access to novel uses of existing therapies for patients with a serious condition with unmet medical needs. Notable Dates and Timelines – New MAPP published, by Dec.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52