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Medical devices; medical device reporting. Direct final rule

Federal Register

|March 2, 2005

Abstract:

The Food and Drug Administration (FDA or we) is amending its regulation governing reporting of deaths, serious injuries, and certain malfunctions related to medical devices. We are revising the regulation into plain language to make the regulation easier to understand, and we are making technical corrections. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule, under FDA's usual procedures for notice and comment, to provide a procedural framework to finalize the rule in the event we receive any significant adverse comment and withdraw the direct final rule.

Insights

The Food and Drug Administration (FDA) is updating medical device reporting regulations for clarity and ease of understanding. These changes aim to improve how deaths, injuries, and malfunctions are reported to the FDA.

Area of Science:

Regulatory Science
Medical Device Safety
Public Health Policy

Background:

Current regulations for reporting medical device adverse events require revision.
Plain language and technical corrections are needed for better comprehension.

Purpose of the Study:

To amend the Code of Federal Regulations (CFR) concerning medical device reporting.
To enhance clarity and accessibility of medical device safety reporting requirements.

Main Methods:

Direct final rule publication for immediate effect.
Companion proposed rule for notice and comment procedures.
Revision of existing FDA regulations on medical device reporting.

Main Results:

The FDA is revising regulations on reporting deaths, serious injuries, and malfunctions.
The updated regulation will be in plain language.
Technical corrections are being implemented.

Conclusions:

The amendment aims to simplify and improve the understanding of medical device reporting.
A dual-rule approach ensures regulatory finalization while allowing for public input.

Read full analysis

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