Makers of medical devices will have to submit 510(k)s to the Food and Drug Administration electronically beginning in October 2023, a new guidance document from the U.S. agency says. Through the 16-page guidance dated Sept. 22, manufacturers are being forcibly nudged...
Manufacturers have been given direction by the U.S. Food and Drug Administration on how they can best comply with the agency’s current good manufacturing practice (CGMP) requirements for combination drug/device products. In a Final Notice published in the Federal...
Manufacturers would apply a risk-based approach to validating software used in quality systems and the production of medical devices under a new proposed guidance document from the U.S. Food and Drug Administration (FDA). Dated Sept. 13, the 25-page draft doc,...
The Food and Drug Administration (FDA) says in a Sept. 7 guidance document that it’s offering templates for diagnostics developers to use as they seek Emergency Use Authorization (EUA) from the U.S. agency for monkeypox diagnostic tests. The templates, which offer...
The Medical Device Coordination Group (MDCG) this week urged manufacturers to make sure they’re in “timely compliance” with the EU’s MDR and IVDR regulations to help stave off product shortages. In a position paper released on Aug. 30, “Transition to the MDR and IVDR:...
As the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) transitions to a new post-Brexit regulatory framework, it has announced that medtech companies will get extra time to comply with regulations. This is good news for the industry, which has faced...
Medical devices are constantly changing and evolving to meet the needs of patients and healthcare professionals. The Medical Device Coordination Group (MDCG) has released a new guidance document, MDCG 2022-6, Guidance on significant changes regarding the transitional...
EUDAMED is one of the key elements of the European Medical Devices Regulation (EU) 2017/745 (MDR) and the In-Vitro Diagnostic Medical Devices Regulations (EU) 2017/746 (IVDR).
Healthcare providers are a prime target for cyberattacks due to many interconnected medical devices and the sensitive patient data they house.
If you are a medical device manufacturer, it is crucial to have the necessary recall policies and procedures in place to handle a potential field action quickly and effectively. A product recall can be costly and damaging to a company's reputation, so it's essential...