FDA Law

FEBRUARY 9, 2024

We previously blogged on the draft guidance ( here ) and on FDA’s broader framework for Digital Health Technologies (DHT) ( here and here ). 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.

Clinic 105

Clinic Manufacturing Provider Electronics 105

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.

Electronics 59

Electronics Manufacturing Provider Medical 59

FDA Law

JULY 20, 2021

FTC received more than 700 comments in response to the notice of proposed rulemaking from individuals, industry groups, consumer organizations, and members of Congress. listing “made,” “manufactured,” “built,” “produced,” “created,” or “crafted” in the United States or in America). The final rule was published on July 14, 2021.

IT 76

IT Electronics Manufacturing Individual 76

FDA Law

MAY 20, 2021

Houck — Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. By Larry K. Accountability Audit.

Management 40

Management Consulting Provider Physicals 40

FDA Law

MAY 20, 2021

Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. By Larry K. Accountability Audit.

Management 40

Management Consulting Provider Physicals 40

FDA Law

DECEMBER 18, 2022

Generally, FDA’s MDR regulations require device manufacturers to submit Medical Device Reports (MDRs) for individual reportable malfunctions within 30 calendar days of the manufacturer becoming aware of the malfunction. In that letter, FDA stated that it would “permit manufacturers.

Medical 59

Medical Manufacturing Individual Provider 59

FDA Law

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

Manufacturing 64

Manufacturing Provider Physicals Electronics 64