The FDA has issued three new draft guidances related to the 510(k) submissions program, including Best Practices for Selecting a Predicate Device, Use of Clinical Data in Premarket Notification and Evidentiary Expectations for Implant Devices. The agency is accepting comments and will host a webinar for stakeholders on October 26, 2023, to provide more information on the guidances.
“This acquisition allows us to leverage Courante’s extensive experience in oncology trials and enhance our capabilities in managing global studies.”
Previous EU regulatory acts did not cover products without an intended medical purpose—typically devices with aesthetic indications. This now changes with Annex XVI of the EU Medical Device Regulation (MDR). Notified Bodies can assess these products for their conformity with the regulation. However, responsibility for proactively pursuing the EU certificate of conformity for the products rests with the manufacturers.
The draft regulations, “The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2023,” serve as an amendment to the existing UK MDR Part 4A post market surveillance requirements, and are currently with the World trade Organisation (WTO) for member comments.
Excess humidity can affect a pharmaceutical’s structure, chemical stability and dissolving rate, and this moisture can come in contact with product at multiple points throughout production and shipping. Fortunately, new technologies are making it easier for manufacturers and shippers to detect and reduce moisture before it damages their products.
Magnetic resonance imaging (MRI) helps discover serious threats early and in a precise and painless way. However, patient safety may be in danger when medical implants interact with the electromagnetic environment. The developers of such implants are obliged to check the safety of their products under these conditions.
The FDA CDRH is seeking input from industry and the public on expanding access to home use medical technologies. The comment period closes on August 30, 2023.
Learn how your peers in MedTech assess and mitigate risks and improve logistics to build more sustainable, resilient supply chains.
On August 11, the FDA released a Final Guidance on Off-the-Shelf Software Use in Medical Devices, which supersedes Off-The-Shelf Software Use in Medical Devices issued September 27, 2019.
Hospital at Home models are expanding capacity for overcrowded hospitals and emergency departments and providing comfort to a growing range of patients. Dave Kerwar, co-founder of Inbound Health, discusses the best candidates for hospital at home care and opportunities for MedTech providers to enhance this model of care, as payers and CMS look at long-term adoption.
