Fraudulent data is becoming more common by the submission. So much so that the FDA recently published a press release reminding medical device manufacturers to scrutinize Third-Party Generated Data.” Regulatory consultant, Michelle Lott, discusses the agency’s use of artificial intelligence to find unusual patterns in submitted data and how you might guard against using fraudulent 3rd-party data.
In the light of new research, Peter Muller and Mike Baird of Schlafender Hase assess how well Class 2 and 3 device manufacturers in Europe and the US are adapting to a rise in regulatory controls.
Diagnostic manufacturers and pharmaceutical sponsors with therapeutics that rely on biomarker identification or companion diagnostics should adjust their commercialization and partnership strategies to fit the new regulatory environment.
An analysis from the Life Sciences legal team at Hogan Lovells.
FDA has finalized its landmark proposed rule that will amend the definition of “in vitro diagnostic (IVD) products” in 21 CFR 809.3 to make explicit that IVDs are medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA), “including when the manufacturer of the IVD is a laboratory.”
San Diego-based medical tech company, Cue Health, announced Monday that it is laying off its entire staff. Similar industry reports indicate a complete shuttering of operations.
“This report validates the broad applicability—and true value—of computational modeling and simulation as a critical engineering discipline. Tangible cost, quality and performance improvements are being realized by the early adopters.”
The purpose of the Best Practices in Supply Chain Resiliency and Quality Working Group is to improve medical device quality and supply chain resiliency by expanding MedAccred adoption through the tiers in the supply chain, identifying best practices to supplement efforts in quality assurance and procurement strategies, and to help mitigate supply chain risks.
Connectivity in medical devices creates new diagnostic and treatment opportunities, yet at the same time increases the risks of cyberattacks—including their consequences for patient safety and data privacy. Now the new IEC 81001-5-1 standard provides clear technical requirements for manufacturers and developers to ensure the cybersecurity of their products across their life cycle.
The FDA has granted several exemptions to its Medical Device Reporting requirements related to events identified in certain real-world data sources, such as medical device registries.
