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The FDA spelled out best practices for the use of patient-reported outcome (PRO) instruments in the development, evaluation, and surveillance of medical devices, in a newly released draft guidance. Read More
It’s possible to learn from failures resulting in unacceptable risks for combination drug-device-biologic products what design input requirements are essential to the safe and effective operation and use of such products, Susan Neadle, head of combination products at Johnson & Johnson, said at the World Drug Safety Congress Americas. Read More
In further Brexit fallout, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) said that devices with the CE mark will continue to enjoy UK recognition until June 30, 2023. Read More
The FDA issued final guidance for devicemakers on the use of the ISO-10993-1 international standard for assessing the biocompatibility risks of devices that come into direct or indirect contact with the human body. Read More
If a modification could affect parts of the device with direct or indirect contact with the body, a biocompatibility evaluation should be conducted to assess the potential impact of the change, the agency said. Read More
It’s possible to learn from failures resulting in unacceptable risks for combination drug-device-biologic products what design input requirements are essential to the safe and effective operation and use of such products, Susan Neadle, head of combination products at Johnson & Johnson, said at the World Drug Safety Congress Americas. Read More
Australia’s Therapeutic Goods Administration move to exempt from regulation certain classes of software-based medical devices that present a lower risk to safety drew broad support in written comments to the agency. Read More
The FDA issued an update on adverse events related to breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and breast implant illness. Read More
The FDA has updated its policy on COVID-19 testing, clarifying that manufacturers of multi-analyte respiratory panels which include SARS-CoV-2 are now eligible for Emergency Use Authorization (EUA). Read More