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Current Issue
Strike With a Heavy Object
How Many Is Too Many?
Blame the User or Blame the Design?
Recalls and UDIs
A Different Kind of Postmarket Action
FDA on Risk-Benefit Analysis for Recalls
FDA Communications, Product Codes, And UDIs
Maybe That Wasn't Such a Good Idea
When One Plus One Is Less Than Two
Recalls Versus Enhancements
Warning Letter ... and Then What?
Confession and Blame (Revisited)
Surveilling Postmarket Surveillance
Safe, Portable Bed Rails: There's No Such Thing
A Standalone Software Warning Letter
FDA Inspections of Invacare and Consent Decree of Injunction
Complications Associated With Intrathecal Pumps
Effects of Electronic Medical Records: Causation Versus Correlation
Off-label Use and Adverse Effects
The Innovation and Safety Dilemma: An FDA and Industry Challenge
FDA 510(k) Revisions—Part II
The FDA Can Protect US
Confirmation: Not All “Safety” Sharps Are Equally Safe
OIG Report Critical of FDA's MDR System
When HIT Hurts
Steris and the FDA
A Reminder From Canada on Bed Side Rail Entrapments
Are “Lessons” Really “Learned”?
Refining “Close Call” Definitions
Medical Devices, Computers, and Computer Networks
When a Device Fails: One Person's Experience With Treatment Error and Its Aftermath
That Pesky Learning Curve
Instructions That Cannot be Followed
Fifteen Minutes?
2017 Recall for Pre-2013 Devices
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