Topic
medical device reporting
12 published works
Bill Madden's Blog
Medical: TGA implements new medical device regulations for adverse event reporting.
By Bill Madden
“From 21 March 2026, all public, private and day hospitals in Australia will be required to report medical device-related injuries or suspected injuries to the TGA. This mandatory reporting is…
Drug & Device Law
Thinking About the FDA’s Alternative Summary Reporting Program
By Bexis
Bexis has been updating the preemption chapter of his treatise on drug/device product liability litigation. He came across several preemption decisions involving defendants who employed the FDA’s “alternative summary reporting”…
Health Care and Life Sciences
Unpacking Averages: Analyzing the Relationship Between MDRs and Recalls
By Bradley Merrill Thompson, Colleen Hittle, James A. Boiani
Recently Colleen and Brad had a debate about whether Medical Device Reports (“MDRs”) tend to trail recalls, or whether MDRs tend to lead to recalls. Both Colleen and Brad have…
Health Care and Life Sciences
Unpacking Averages: Using Natural Language Processing to Extract Quality Information from MDRs
Over the spring and summer, I did a series of posts on extracting quality information from FDA enforcement initiatives like warning letters, recalls, and inspections. But obviously FDA enforcement actions…
Health Care and Life Sciences
Obscure FDA Device Reporting Exemptions Draw Patient and Provider Concern
By Bonnie Odom
Many physicians rely on publicly available reports to assess the safety of the devices they use on patients, but in some cases, these reports aren’t painting the full picture. A…
Product Liability & Mass Torts Blog
New Legislation Gives More Time for Medical Device Reporting
By Sarah K. Angelino, John N. Scholnick
Under the recently enacted FDA Reauthorization Act of 2017, drug and device manufacturers will have more time to report device malfunctions to the U.S. Food and Drug Administration (FDA). Current standards require…
Health Law Diagnosis
FDA Guidance on Cybersecurity in Medical Devices
By Robinson+Cole's Health Law Group
On December 28, 2016, the Food and Drug Administration (FDA) issued guidance on Postmarket Management of Cybersecurity in Medical Devices. The guidance clarified aspects of the reporting requirements under Part…
Life Sciences Legal Update
MDR Reporting Final Guidance
By Lisa Baird
FDA issued a final guidance on November 8, 2016, “Medical Device Reporting for Manufacturers”. As with all such guidance documents, it is nonbinding: “It does not establish any rights for…
Triage Health Law
FDA Working to Modernize Medical Device Reporting in Hospitals
By John Wyand
Recent medical device adverse events prompted FDA to take a fresh look at the ways it collects data related to medical device adverse events from hospitals. FDA examined some high-profile…
Drug & Device Law
Guest Post on Adverse Event Reports & Updating Cheat Sheet
By Bexis
It takes time and effort to keep all our scorecards and cheat sheets up to date. So we fell all over ourselves when a Reed Smith associate, Kevin Hara, offered…