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Medtech Insight
By Shawn M. Schmitt 14 Nov 2022
Toyota Motor North America's Kristen Tabar told a roomful of medical device quality and regulatory professionals at a Case for Quality forum that they can infuse quality concepts into every nook and cranny of their firms by adopting the car-maker's quality strategy of reflection, education, celebration and planning. "I don’t want to make it sound like it’s sort of cult-y, but it’s kind of cult-y," Tabar quipped.
Topic Company Analysis Strategy
Medtech Insight
By Shawn M. Schmitt 26 Aug 2021
Baxter says customers complained of “multiple pumps within their fleets” encountering system errors after they made changes to their network configuration and server systems. It’s the second software-related setback for the device maker in recent weeks.
Medtech Insight
By Shawn M. Schmitt 20 Aug 2021
The Safety Scalpel N11 is a component of Cardinal Health’s Argyle UVC Insertion Tray, which was recalled because it didn’t include the scalpel’s instructions for use. The recall has been labeled high-risk class I by the US FDA.
Medtech Insight
By Shawn M. Schmitt 22 Apr 2021
A US FDA official says the agency’s taking steps to plan for post-pandemic on-site inspections that could look slightly different than typical agency audits pre-COVID-19. But in the interim, some companies are being asked to participate in voluntary Remote Regulatory Assessments.
Medtech Insight
By Shawn M. Schmitt 24 Mar 2021
The US FDA on 24 March gave its highest risk designation to a recall of the company’s Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir. The device is used on newborns, infants and small pediatric patients undergoing a cardiopulmonary bypass procedure.
Medtech Insight
By Shawn M. Schmitt 27 Nov 2020
The US agency has relaxed its enforcement policy for X-ray, ultrasound and magnetic resonance imaging systems, as well as software for analyzing images, as US health care workers fight the novel coronavirus.
Topic Coronavirus FDA
Medtech Insight
By Shawn M. Schmitt 27 Nov 2020
Abbott will be paid $760m for the tests under a contract with the Department of Health and Human Services and the Department of Defense.
Topic Coronavirus
Medtech Insight
By Shawn M. Schmitt 27 Nov 2020
A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this first installment of a 10-part series, a procedure for hosting inspections is addressed.
Topic Compliance FDA
Medtech Insight
By Shawn M. Schmitt 17 Nov 2020
The US FDA’s internal deadline of October 2020 for putting out a draft of its retooled Quality System Regulation is the fourth it failed to meet. The agency has been harmonizing its decades-old QSR with ISO 13485:2016 for more than two years.
Topic Regulation
Medtech Insight
By Shawn M. Schmitt 09 Oct 2020
The American Medical Association has added two new Current Procedural Terminology (CPT) codes for reporting antigen tests that detect COVID-19 and influenza. And a third new code, 87811, should be used to report “infectious agent antigen detection by immunoassay with direct visual observation.”
Topic Coronavirus
Medtech Insight
By Shawn M. Schmitt 16 Apr 2020
A former US FDA investigations branch director explains how a paper-based “desk audit” would be performed by the agency in lieu of an on-site quality systems inspection. Last month the FDA hit the pause button on in-person inspections as the coronavirus pandemic rolls on.
Topic Coronavirus
Medtech Insight
By Shawn M. Schmitt 09 Apr 2020
In three separate immediately-in-effect guidance documents, the US agency says makers of infusion pumps and accessories, extracorporeal membrane oxygenation (ECMO) and cardiopulmonary bypass devices, and remote ophthalmic assessment and monitoring devices can make “limited modifications” to those products so they can be used during the ongoing novel coronavirus crisis, without the need for firms to seek out a new 510(k). A fourth guidance says clinical electronic thermometers that aren’t yet 510(k)-cleared by the FDA can be distributed for use.
Topic Coronavirus
Medtech Insight
By Shawn M. Schmitt 20 Mar 2020
Two Hogan Lovells attorneys say the medical device industry is jittery about President Trump’s 18 March invocation of the Defense Production Act. That’s because the DPA gives the government broad authority to, among other things, order manufacturers to make particular products in a time of great national need. That can be a problem if those companies can’t make complex products like ventilators – or don’t make devices in the first place. After all, “we’re not making hubcaps. We’re making important devices,” Hogan Lovells partner Mike Heyl tells Medtech Insight.Is Making Industry Sweat.
Topic Coronavirus Medtech
Medtech Insight
By Shawn M. Schmitt 17 Feb 2020
In a late Friday news statement, agency head Stephen Hahn also warned of possible “shortages of critical medical products” The US agency has suspended all routine surveillance inspections in China through the end of March because of coronavirus fears, commissioner Stephen Hahn announced late on 14 February. Despite expecting medical product shortages, Hahn said the agency is being proactive: “We are not waiting for drug and device manufacturers to report shortages to us” before acting. The timing of Hahn’s statement – at 6 p.m. EST on a Friday, at the beginning of a three-day US holiday weekend – suggests he isn’t particularly excited to share the information.
Topic Coronavirus
Medtech Insight
By Shawn M. Schmitt 29 Jan 2020
The US-Mexico-Canada (USMCA) treaty calls for the three countries to “recognize audits” performed under the Medical Device Single Audit Program. MDSAP is already used by device makers in the US and Canada so they can undergo one audit by an accredited third party to satisfy quality regulations. That leaves Mexico as the odd country out when it comes to using the popular program – and that means it has some catching up to do after the USMCA is ratified by all three nations. Former longtime FDA official Kim Trautman weighs in on how Mexico can incorporate MDSAP into its regulatory framework.
Topic Compliance
Medtech Insight
18 Jul 2022
Medtech Insight
15 Jul 2022
Medtech Insight
15 Jul 2022
In Vivo
13 Jul 2022
Medtech Insight
13 Jul 2022
Medtech Insight
08 Jul 2022
Medtech Insight
06 Jul 2022
Medtech Insight
04 Jul 2022
Medtech Insight
24 Jun 2022
Medtech Insight
16 Jun 2022
Medtech Insight
14 Jun 2022
Medtech Insight
10 Jun 2022
Medtech Insight
08 Jun 2022
Medtech Insight
07 Jun 2022
Medtech Insight
06 Jun 2022
