FDA Law

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time.

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Electronics Manufacturing Provider Medical 59

FDA Law

JANUARY 14, 2025

The passing of the law which, among other things, amended the Federal Food, Drug, and Cosmetic Act to include requirements for facility registration and product listing, safety substantiation, adverse event reporting, and requirements for FDA to issue several new regulations, brought excitement and anxiety. Just on the cusp of 2024, on Dec.

Manufacturing 59

Manufacturing Electronics 59

FDA Law

FEBRUARY 9, 2024

Drug or biologic sponsors should engage with manufacturers of DHTs to ensure appropriate evidence has been established for the DHTs before use in a clinical study. However, in general, FDA does not intend to request machine or raw data that require electronic processing to be understood in an inspection.

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Clinic Manufacturing Provider Electronics 105

FDA Law

AUGUST 27, 2023

The Guidance specifically states that it is issuing the Guidance – applicable to trading partners including manufacturers, distributors, dispensers, and repackagers – to address industry “readiness” to comply with the DSCSA’s provisions. Drug manufacturers have had electronic systems in place since 2017.

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Supply Chain Electronics Manufacturing Provider 52

FDA Law

SEPTEMBER 22, 2024

MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. SCG : Modified version of another manufacturer’s FDA-authorized test within scope described in preamble to LDT Final Rule. SCH : LDT, approved by NYS CLEP. It should be noted that 21 CFR 803.18(b)(1)(ii)

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Manufacturing Electronics Provider Management 64

FDA Law

JULY 20, 2021

We previously reported on events that resulted in this rule. listing “made,” “manufactured,” “built,” “produced,” “created,” or “crafted” in the United States or in America). The final rule was published on July 14, 2021. For false or misleading qualified MUSA claims, FTC authority remains limited to injunctive relief.

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IT Electronics Manufacturing Individual 76

FDA Law

JANUARY 5, 2023

But a compromised device is a threat to patient safety, so that timeline that could change in the event of an adverse event that imperils consumer health. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well. FDA has shown a willingness to intervene in this space.

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Manufacturing Patient-Centered Provider Telehealth 59