FDA Law Blog

OCTOBER 14, 2021

Mullen — In recent years, for novel robot assisted surgery (RAS) devices, FDA’s Center for Devices and Radiological Health (CDRH) has taken the approach of clearing RAS devices for specific indications for use. Rather, FDA seems intent on regulating RAS devices almost as if they were therapeutics responsible for long term clinical outcomes.

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FDA Law Blog

AUGUST 7, 2023

By Véronique Li, Senior Medical Device Regulation Expert — The Center for Devices and Radiological Health (CDRH) offers learning opportunities for new and experienced CDRH staff through the Experiential Learning Program (ELP).

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FDA Law Blog

DECEMBER 11, 2023

1] Yet FDA’s conclusions about the Agency’s ability to regulate the entire laboratory industry are based on fundamentally flawed assumptions about the number of entities and tests that will be subject to FDA regulation. 5] This stratification, though, assumes that LDTs will follow the same pattern as IVDs currently regulated by FDA.

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FDA Law Blog

FEBRUARY 28, 2022

The Guidance provides practical advice for device manufacturers to utilize patient engagement in clinical studies. address common questions and misconceptions about collecting and submitting to FDA patient engagement information regarding the design and conduct of a medical device clinical study.”.

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FDA Law Blog

OCTOBER 10, 2022

The final CDS Guidance represents a marked change in approach from prior drafts and foreseeably will result in the regulation of many types of CDS that were previously considered to be Non-Device CDS or low-risk Device CDS under enforcement discretion. The final guidance focuses on labeling as a means to effectuate Criterion 4.

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XTalks

MAY 13, 2022

Container closure systems are highly regulated by health agencies. Manufacturers must conduct various tests such as stability and extractables and leachables (E&L) testing for packaging materials and enclosures to meet safety and efficacy guidelines. USP and EP Organizations for Container Regulation. > umbrella).

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XTalks

JUNE 12, 2023

Medtronic, the leading global medical device manufacturer, reported a revenue growth of 5 percent in the last fiscal year, affirming its position as the top global medical technology company by revenue. a specialist in developing and manufacturing universally implantable biotechnologically produced human tissue.

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The Pharma Data

NOVEMBER 12, 2021

director of the FDA’s Center for Devices and Radiological Health. “We In response to the recall, the FDA lately conducted an examination of a Philips Respironics’ manufacturing installation to determine what may have caused or contributed to the froth issues and assess adherence to the agency’s conditions for quality manufacturing.

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The Pharma Data

NOVEMBER 17, 2020

director of FDA’s Center for Devices and Radiological Health. Lucira Health, the test manufacturer, has also developed box labeling, quick reference instructions and health care provider instructions to assist with reporting. . . . .

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The Pharma Data

MAY 3, 2021

Chilean regulator sees no clouds over Sputnik vaccine despite Brazilian rejection ( Reuters ). Canada’s regulator holds Johnson & Johnson vaccine over Emergent link ( NYTimes ). India’s vaccine shortage will last months, biggest manufacturer warns ( FT ). Coronavirus Pandemic.

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FDA Law Blog

FEBRUARY 20, 2025

Gibbs The multi-decade battle over FDAs power to regulate Laboratory Developed Tests (LDTs) had its day in court earlier this week. Many of the fired employees were within the Center for Devices and Radiological Healththe Center that is tasked with regulating all devices, including in vitro diagnostics, which FDA argues includes LDTs.

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XTalks

SEPTEMBER 14, 2020

In April alone, food and accommodation services had dropped by a good 42 percent, manufacturing followed with a 22.5 Meanwhile, researchers at the University of Toronto are developing synthetic therapeutic antibodies that they say are more potent than naturally occurring antibodies and which can be readily manufactured in large quantities.

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