FDA Law Blog

FEBRUARY 4, 2024

Mullen — On January 18, 2024, the director of FDA’s Center for Devices and Radiological Health and the chief medical officer and acting director of CMS’ Center for Clinical Standards and Quality issued a joint press release supporting FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs). Javitt & Allyson B.

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Cloudbyz

JULY 31, 2024

The Principal Investigator (PI) of any study, be it drug or device, has many responsibilities, including ensuring regulatory compliance, overseeing the conduct of the study, and safeguarding the well-being of study participants.

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The Pharma Data

NOVEMBER 12, 2021

director of the FDA’s Center for Devices and Radiological Health. “We During the examination, the FDA investigator made several compliances that are outlined in an examination bonus report, also known as an “ FDA Form 483.” The FDA investigator handed a list of their compliances to the company. Source link: [link].

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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

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.

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XTalks

MAY 13, 2022

Container closure systems are highly regulated by health agencies. USP and EP Organizations for Container Regulation. The FDA’s CDRH (Center for Devices and Radiological Health) branch would own the filing in this case. shaking, changes in pressure, etc.). Requirements for Primary Packaging Components. > umbrella).

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XTalks

JUNE 12, 2023

Siemens Healthineers further demonstrated its commitment to innovation at the European Congress of Radiology in Vienna, showcasing its revamped Acuson ultrasound portfolio. Significantly, Roche received full compliance under the In-Vitro Diagnostic Medical Devices Regulation (IVDR) from the European Union.

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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. Citing the May 6 compliance date for Stage 1 of the LDT Rule, both ACLA and AMP asked that Judge Jordan issue his ruling expeditiously. By Allyson B. Mullen & Jeffrey N.

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