Warning Letter Roundup & Recap – April 9, 2019
In the only device-related warning letter released by the US FDA this week, Inova Genomics Laboratory was dinged for selling products without premarket approval.
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The US HHS defends its recent decision to relieve the FDA from oversight of laboratory developed tests in a new FAQ sheet, saying the agency hardly ever enforced the premarket review of LDTs in the first place.
US Lawmakers Reintroduce Bill To Better Patient Access To Prosthetic Devices, Other Limb-Loss Technologies
The bipartisan Triple A Study Act directs the Government Accountability Office to report back to Congress on the coverage of assistive technologies for people with limb loss or limb difference.
The US FDA on 12 April affixed its highest risk classification to a recall of certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) made by Medtronic. It’s the third class I recall for the medtech giant since 1 March.