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

FEBRUARY 9, 2024

is used in a clinical investigation of a drug or biologic under IND and the DHT meets the definition of a significant risk device a submission of an IDE to the FDA is required unless all the information required for the IDE is contained in the IND. smartphones and tablets) for remote data acquisition in a clinical investigation.

Clinic 105

Clinic Manufacturing Provider Electronics 105

FDA Law

MAY 20, 2021

The investigators ask the registrant’s designated responsible employee, such as the Operations or Compliance Manager, for informed consent by signing a Notice of Inspection (“DEA Form-82”). Registrants should consult with counsel and their Human Resources departments in deciding whether to provide this information.

Management 40

Management Consulting Provider Physicals 40

FDA Law

MAY 20, 2021

The investigators ask the registrant’s designated responsible employee, such as the Operations or Compliance Manager, for informed consent by signing a Notice of Inspection (“DEA Form-82”). Registrants should consult with counsel and their Human Resources departments in deciding whether to provide this information.

Management 40

Management Consulting Provider Physicals 40

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.

Manufacturing 64

Manufacturing Provider Physicals Electronics 64

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

JANUARY 8, 2023

The Act mandates that DEA streamline and accelerate registration application procedures for cannabis researchers and manufacturers of cannabis for research. With respect to timing, DEA must issue a registration or request supplemental information within 60 days after receiving a complete application. Cannabis Researcher Registrations.

Medical 64

Medical Manufacturing Electronics Provider 64