A new US FDA draft guidance explains what the agency wants to see in submissions for the devices, which are used to contain potentially cancerous tissue during laparoscopic surgery. Strength, permeability and leakage testing are all key considerations.
New draft guidance from the US Food and Drug Administration lays bare the types of non-clinical testing the agency hopes to see in support of premarket submissions for gynecologic and general laparoscopic power morcellation containment systems.
The systems are used during laparoscopic power morcellation procedures, particularly gynecological procedures such as hysterectomy or the removal of uterine...
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.
The US FDA issued two safety alerts concerning associated risks from unauthorized medical devices. The alerts are consistent with a larger effort to clamp down on consumer goods that have not been subject to agency review.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. 60 documents have been posted on the tracker since its last update.
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.
The US FDA issued two safety alerts concerning associated risks from unauthorized medical devices. The alerts are consistent with a larger effort to clamp down on consumer goods that have not been subject to agency review.
The newly released Unified Agenda, which outlines actions the executive branch plans to take in the coming months, includes several medtech-related proposals.
Legal experts say a recent warning letter from the US FDA to a maker of dental products could upend a long-standing dental industry view that its operations and products are exempt from agency oversight.
