Steril Milano EtO Deception: FDA Justifies 9-Day Gap From Import Detention To Industry Alert
If the US FDA knew Steril Milano S.R.L. was falsifying ethylene oxide (EtO) certificates on 24 May, why did nine days pass before the agency alerted all of industry? The FDA explains the choice to Medtech Insight.
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Italian Sterilization Firm Falsified Certificates Since 2016; 97 Device Makers May Be Impacted, FDA Warns
Biopsy needles, catheters, intravascular administration sets, arthroscopes and syringes are just a few of the products affected by the deception, some of which have already been recalled. The Steril Milano S.R.L. Reggiolo and Monza ethylene oxide sterilization facilities were shuttered in March.
Speaking Of Medtech, Ep. 10: FDA’s TAP Pilot
In this FINAL EPISODE of Speaking Of Medtech: The US FDA got something it desperately wanted in its latest user-fee package with industry: a Total Product Lifecycle Advisory Program pilot, or TAP. The agency says TAP will allow for earlier and more frequent engagement with developers – but is it needed?
Thumbs Up: FDA Authorizes Weight Loss Suturing Systems From Apollo Endosurgery
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