Certain models and lots of Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringes were recalled on 16 June because they “may exhibit skewed odd number line graduation markings on their syringe barrels.”

On this week’s podcast we give an update on the Medical Device User Fee Amendments (MDUFA V) process. We also discuss US FDA device center director Jeff Shuren’s comments about pre-submission meetings and IVD submissions during a recent podcast interview with AdvaMed. Finally, we talk about the FDA’s latest scheduling of the release of its draft harmonized Quality System Regulation, due out this month.

US FDA device center director Jeff Shuren is asking whether the agency’s engagement with industry has been changed forever because of COVID-19.

Jeff Shuren, director of the US FDA’s device center, promised in a podcast interview with AdvaMed that the agency’s backlog of in vitro diagnostic submissions not related to COVID-19 will begin abating “in the next few weeks.”

Medtech quality expert Rob Becker says the COVID-19 pandemic has likely changed the structure of audits and inspections forever, possibly ending the use of on-site “front rooms” where inspectors would work and “back rooms” where company employees would fulfill requests for documents and other items.

Sound abatement foam used in particular bi-level positive airway pressure (BiPAP), continuous positive airway pressure (CPAP), and other mechanical ventilator devices made by Royal Philips could degrade, posing a risk to patients.