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.
Tags
510(k), cardiac, device, supply chain
