More than 50 medtech testing sites win FDA pilot accreditation

The FDA announced today that more than 50 laboratory sites were chosen to participate in its program for streamlined regulatory reviews.

In total, 53 sites made the FDA’s initial list for participation in its Accreditation Scheme for Conformity Assessment (ASCA) program, which will set out to support more streamlined regulatory reviews of medical device market applicants’ compliance to voluntary consensus standards, according to a news release.

All sites selected by the FDA are designated to perform basic safety and essential performance testing to ANSI/AAMI 60601-1 as well as IEC 61010-1 standards for medical devices undergoing 510(k) and other premarket submissions. Also included in the ASCA program is testing to biocompatibility standards such as ISO 10993, although no labs that are currently on the FDA list has been designated to provide such testing at this time.

Cook Research Incorporated (CRI), a part of Cook Medical, was one of the 53…

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The worst catheter-based device recalls of 2020

Top: Teleflex Langston Dual Lumen catheter; Bottom: BSX Imager II, Endologix Ovation iX, Teleflex AC3 Optimus Intra-Aortic balloon pump

The U.S. saw nine serious medical device recalls related to catheters in 2020 — up from four the previous year, according to the FDA.

FDA in 2020 reported a total 33 medical device recalls at its most serious Class I level, down from 49 in 2019.

The list of the most serious catheter-based device recalls in 2020 includes products from major companies including Medtronic and Teleflex, and catheters ranging from congenital heart treatment devices to contrast material delivery devices.

Here are the nine most serious catheter-based device recalls of 2020.

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