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FDA Updates Medical Device Shortages List


The FDA has updated its Medical Device Shortages List to remove Specimen Collection, Laboratory Reagents and Testing Supplies, Transport Media Device, Saline Vascular Access Flush, and Certain Ventilation-Related Products. This comes as supply chain issues from the COVID-19 pandemic continues to improve, albeit at different speeds around the globe. Non-continuous ventilators had been in short supply since at least August of 2020, according to Medical Design & Outsourcing.

While the global supply chain may have improved, 11 products remain on FDA’s Medical Device Shortages List. These products span across several categories, including Anesthesiology, Cardiovascular, Cardiac Diagnostic and Monitoring, Dialysis-Related Products, General Hospital and Plastic Surgery Devices, Radiological Devices, and Certain Ventilation-Related Products.

Another supply chain challenge affecting the global medical electronics market is a shortage of semiconductor chips, according to SkyQuest. To that end, FDA has issued guidance documents, including Deciding When to Submit a 510(k) for a Change to an Existing Device or Software Change to clarify when a change in a medical device might trigger the requirement that a manufacturer submit a new premarket submission.

Section 506J of the FD&C Act (21 U.S.C. 356j) requires FDA to maintain a publicly available, up-to-date list of the devices determined to be in shortage. Under section 506j, in some circumstances, manufacturers of certain devices must notify the FDA of an interruption or permanent discontinuance in manufacturing. According to FDA, the mandatory nature of these “506J notifications” applies only during or in advance of a declared public health emergency. However, FDA continues to encourage device manufacturers to notify the FDA about manufacturing interruptions.



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Arash Pia

Arash Pia focuses his practice on providing patent prosecution and litigation services for his clients.

Arash received his J.D. from Loyola Law School, Los Angeles while he was working full time as a Civil Engineer. At law school, he worked as a mentor for incoming law students. He also worked as a mentor for the award-winning Judge Stephen O’Neil Trial Advocacy Mentoring Program.

Arash received his Bachelor of Science in Civil Engineering from California State Polytechnic University in Pomona. He later received his Master of Science degree also in Civil Engineering from the University of Southern California’s Viterbi School of Engineering in Los Angeles. Before joining the firm, Arash worked on a variety of multi-million-dollar civil design and construction projects, including port facilities, educational buildings, and gas transmission systems. He is a licensed Professional Engineer in the State of California.

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