An 8-page final guidance from the US agency lays bare reasons why it would deny an export certificate to a company. It also explains how a firm can appeal if it is turned down for a certificate. The guidance was developed because the FDA Reauthorization Act of 2017 – FDARA – required the agency to provide a rationale when it turns down a request for a Certificate to Foreign Government (CFG), including listing any specific grounds for a finding of noncompliance.

US Democratic Sens. Elizabeth Warren of Massachusetts and Patty Murray of Washington State recently sent a letter to FDA officials Brett Giroir and Jeff Shuren that raises doubts about a planned bill calling for a progressive approval pathway for medical devices.

While a government agency shutdown due to lack of agreement between Congress and the Trump administration over funding for the US Food and Drug Administration and other federal agencies seems less likely this year than last, the FDA will still have carry out its 2020 mission in the short term on 2019 continuing resolution funding – probably through December – legislative experts say.

No device-related warning letters were released by the US FDA the week of 12 November.

Medtech consultant Arthur Brandwood explains why the EU’s medtech regulations are sending shockwaves through so many other countries, and why CE marking may be unlikely to return to its previous position as the preeminent international certification.

Three global guidances dating back 10 years or more have been updated by the International Medical Device Regulators Forum (IMDRF). 

An 8-page final guidance from the US agency lays bare reasons why it would deny an export certificate to a company. It also explains how a firm can appeal if it is turned down for a certificate. The guidance was developed because the FDA Reauthorization Act of 2017 – FDARA – required the agency to provide a rationale when it turns down a request for a Certificate to Foreign Government (CFG), including listing any specific grounds for a finding of noncompliance.

Zimmer Biomet has issued a recall on its ROSA Brain 3.0 software platform due to a software issue that could cause patient injury.

Cisco Vicenty tells how the US agency will structure its pilot program for device-makers with less-than-stellar compliance histories that want to use the CMMI maturity model framework to improve the quality and maturity of their manufacturing organizations – and clean up their compliance problems along the way. The FDA – which is partnering with the Medical Device Innovation Consortium (MDIC) and Pittsburgh’s CMMI Institute on the voluntary pilot – will offer the opportunity to 10 firms “that have had a negative inspection outcome, a warning letter, or possibly other regulatory action,” Vicenty explains to Medtech Insight. The pilot launches next year.

Nypro, a Jabil Company, offers design, engineering, supply chain and manufacturing services for the medical device, diagnostics, pharmaceutical and consumer health markets. In a contributed analysis, Jabil/Nypro's Joe McBeth, Erich Stein, Brad Womble and Doug Bond suggest the medical device industry has been relatively slow to adopt connected technologies, and must be ready to adapt more quickly in the future.

Abbott's CEO Miles White will step down at the end of March 2020 after 21 years on the job. Robert Ford, Abbott's president and COO, will succeed White as Abbott's CEO. See what William Osborn, chair of Abbott's board of directors' nominations and governance committee, said about it here.

Energy surgical tools developer OmniGuide Holdings welcomes a new VP of global marketing to manage worldwide marketing activities and a managing director for its OmniGuide Surgical Strategic Business Unit to guide technology innovation strategy.

Ted Tanner, CTO of IBM Watson Health, recently sat down with Medtech Insight to talk about his plans for developing a blockchain-based data information exchange network in partnership with health organizations to create 'frictionless' computing. See what Tanner said about it here.

Ted Tanner, the new chief technology officer and chief architect of IBM Watson Health, recently sat down with Medtech Insight to discuss his plans for the company. In 2020, IBM will start testing the first use cases of its blockchain-based data information exchange network, a partnership with several health-care organizations, aimed to reduce administrative errors and save costs. Tanner refers to blockchain as an "enablement platform" that augments computing power.

Catherine Mohr, president of the Intuitive Foundation, recently sat down with Medtech Insight to talk about her plans for the foundation including building a global, data-based network to train future surgeons who will be caring for millions of new patients in Asia and Africa. See what Mohr said about it here.

The French start-up claims first-in-man success for heart valve “softening” treatment and plans further trials for an EU launch.

On-going scrutiny has not explained an apparent link between paclitaxel-coated cardiac devices and an increased mortality rate, speakers said at the Vascular Interventional Advances (VIVA) 2019 conference in Las Vegas. See what Krishna Rocha-Singh, a VIVA board member, said about it here.

Research investigating outcomes in patients treated with paclitaxel-coated devices demonstrated a consistent if modest mortality signal when compared to bare-metal stents. However, the signal was not seen in real-world data, and some researchers question whether the signal might stem from problems in the original trials. 

Results of the EXTRACT PE trial, presented at the Vascular Interventional Advances Annual Meeting in Las Vegas, will support an application to the US FDA for Penumbra’s Indigo system for aspiration mechanical thrombectomy in patients with acute pulmonary embolism.

Thomas Zeller of Germany’s Universitäts-Herzzentrum Freiburg-Bad Krozingen presented study data at the VIVA 2019 conference that showed peripheral artery disease (PAD) patients treated with paclitaxel-coated balloons for four years found good results – even in more complex cases. See what Zeller said here.

An overview of October’s ten most-read Medtech Insight articles on topics related to research and development of new medical technology.