Participants at a recent FDA workshop on refurbishing, reconditioning and servicing used medical devices emphasized the need for manufacturers to continue to make correct manuals and spare parts available for user-facilities to maintain older devices, and to oversee input into product training. The need for standards to certify or accredit those who refurbish or service used devices was also emphasized at the meeting.
Both hospital purchasers and biomedical engineers who have to maintain refurbished and reconditioned devices say they run into problems obtaining well-written maintenance manuals and the correct parts needed to keep the products in good condition. That was the message from participants at a recent FDA workshop.
The purpose of the Oct. 27-28 workshop was to discuss potential regulations or standards that might support third-party processes for...
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US FDA has greenlighted Senseonics’ Eversense 365 continuous glucose monitor, which must be replaced just once a year. Capable of being integrated with compatible insulin pumps as part of an automated insulin delivery system, the fully implantable device lasts 185 days longer than the Eversense E3 sensor and far outstrips competing CGMs, which last only for 10-14 days.
With the reversal of the Chevron doctrine in June, lower courts will now have more say in deciding regulatory statutes when the language is murky. But will that open the door to more legal challenges from the healthcare industry against government regulations it finds unfavorable? A pair of legal experts recently discussed the potential implications of the Court’s decision.
The US FDA released six more device classifications in early September, including products from Edwards, Interscope, and Baxter Healthcare.
This week, a Delaware court awarded Auris Health shareholders $1bn in a lawsuit against Johnson & Johnson; Abbott recalled some FreeStyle Libre 3 sensors; and McKesson purchased a controlling interest in a Florida cancer care chain.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Nearly 80 documents have been posted on the tracker since its last update.
The Food and Drug Administration’s final guidance outlines the agency’s thinking for sponsors submitting de novo requests electronically, which they must starting in October 2025.
