• New Intended Use Rule Finalized🔍
• FDA issues final rule clarifying its “intended use” regulations for ...🔍
• FDA Issues Final Rule Overhauling Regulation of Medical Gases🔍
• Five Ways FDA's New Final Rule On Intended Use Could Affect ...🔍
• FDA Issues Final Rule on Laboratory Developed Tests 🔍
• FDA Issues Final Rule Classifying LDTs as Medical Devices🔍
• LDT Final Rule Series🔍
• FDA Device Oversight From 1906 to the Present🔍

New Intended Use Rule Finalized - Foley Hoag LLP

First, the Final Rule reiterates FDA's position that “any relevant source” can be considered when determining if a drug is being marketed for a ...

FDA issues final rule clarifying its “intended use” regulations for ...

The FDA issued a final rule (RIN 0910-A147) on August 2, 2021, to clarify its “intended use” regulations for pharmaceutical products and ...

FDA Issues Final Rule Overhauling Regulation of Medical Gases

On June 18, 2024, the U.S. Food and Drug Administration (FDA) issued a final rule that governs current good manufacturing practices (CMPGs), ...

Five Ways FDA's New Final Rule On Intended Use Could Affect ...

Cosmetic, food, dietary supplement, and other consumer products, even without therapeutic claims, may now be subject to regulation as drugs ...

FDA Issues Final Rule on Laboratory Developed Tests (LDTs ...

By: Samantha Hong and Suzan Onel On April 29, 2024, FDA announced the issuance of a final rule that amends FDA regulations to make explicit ...

FDA Issues Final Rule Classifying LDTs as Medical Devices

Reasoning behind FDA's new rule for laboratory developed tests · A four-year phaseout plan for enforcement discretion · Targeted enforcement ...

LDT Final Rule Series: Part 1 - Rule Overview - FDA Law Update

And second, it phases out FDA's previous policy of enforcement discretion for LDTs by implementing a four-year, five-step regulation rollout. a.

FDA Device Oversight From 1906 to the Present | Journal of Ethics

As a result, the Pure Food and Drug Act was signed into law in 1906,3 creating a federal entity that would become the FDA. The Federal Food, Drug, and Cosmetic ...

Food, Drug, and Cosmetic Act - StatPearls - NCBI Bookshelf

The 1938 Federal Food, Drug, and Cosmetic Act (FDCA) is a set of United States (US) laws that authorize the Food and Drug Administration (FDA) to oversee ...

MIWG Comments on Intended Use Proposed Rule.pdf

75 To address these concerns, FDA should specify in the final rule that knowledge in combination with safe-harbored speech cannot create a new ...

OGC-97-3 FDA - Government Accountability Office

storing, installing and servicing of medical devices intended for human use. ... The FDA examined the final rule as prescribed by the Act ...

The FDA Receives Mixed Reviews After the Release of Its Final LDT ...

In a news release dated April 29, 2024, the FDA announced its final rule amending its regulations to make explicit that LDTs are IVDs and are ...

In a new final rule, FDA carves out a regulatory niche for medical ...

Industry has been lobbying FDA and Congress to regulate medical gases different from other types of drug products since the 1970s.

FDA's Final Rule on IVDs: a stop gap en route to the VALID Act?

With enhanced FDA oversight, the regulatory framework the Final Rule will usher in is intended to heighten confidence in LDTs, regardless of ...

Importation Final Rule - HHS.gov

use the FDA-approved labeling for drugs imported under this rule would effect an ... (a) For a drug intended for human use that is not an eligible prescription ...

FDA's Final LDT Rule Is Here, and the Changes Show the Agency Is ...

The Food and Drug Administration (FDA) published its final rule on laboratory developed tests (LDTs) in the Federal Register on May 6, ...

FDA Delays Intended Use Regulations - Health Law Diagnosis

The U.S. Food and Drug Administration (FDA) announced that it was delaying until March 19, 2018, a Final Rule that has been viewed as having ...

FDA Issues Final Rule on Regulation of Laboratory Developed Tests

Historically, however, FDA has exercised enforcement discretion and not enforced medical device requirements on LDTs, including pre-market ...

I Can See Clearly Now: FDA Issues Final Guidance on the Form and ...

... Drug Administration issued its final guidance titled, “Unique Device Identification System ... intended to be reprocessed before each use ...

FDA Issues Proposed Rule To Amend Intended Use Regulations

FDA proposes that any final rule would take effect 30 days after the date of publication of the final rule in the Federal Register. Comments to ...