Almost six months into its new "program alignment" inspection approach, FDA's initiative to inspect along commodity lines is still gaining its sea legs. A key FDA official says the agency is taking steps to train and retain specialized investigators. Meanwhile, FDA wants to use a geographic information system (GIS) tool to keep tabs on where investigators are inspecting.
Nearly six months after US FDA rolled out the most sweeping changes ever to its approach to facility inspections, the agency's "program alignment" initiative continues to gain its sea legs.
Program alignment is "only five-plus months old, so it's not going to be perfect yet, but we're getting there," said...
Create an account to read this article
Already a subscriber?
The US FDA posted three warning letters in July, covering medical supply kits, wearables and orthopedics.
Medical device firms often have serious compliance gaps, a recent Veeva MedTech survey found. Only 50% of the companies surveyed are confident in their global registration data, with 70% reporting inconsistencies during audits. The report recommends automation and better data governance.
The US FDA has authorized around 107 devices with Predetermined Change Control Plans in place, with PathAI's AISight Dx digital pathology image management system one of the latest. Medtech Insight talks to Eric Walk, chief medical officer, to find out about the process and its benefits.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
Despite a surge in product recalls across five key industries in the first quarter of the year, medical device recalls were down, according to Sedgwick’s latest recall index. But the firm noted they’ve since ticked up.
Signos links users to Dexcom’s Stelo for glucose readings and historic trends. The app is available in iOS and Android from the firm’s website, where it’s priced at $139 for three-month plan and $129 for a two-month plan, or online app stores.
IQWiG, Germany’s health technology assessment body, is making contingency plans in case key US resources it relies on for information retrieval, when conducting benefit assessments of new medicines, become unavailable.
