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Device industry groups are hesitant to fully endorse the FDA’s push for greater transparency by manufacturers in the labeling information they provide to users of their artificial intelligence- or machine learning-enabled devices. Read More
U.S., European and other regulators require devicemakers to review their operations with some degree of regularity to ensure compliance with GMP rules. Companies are free to determine exactly when, where and how these audits are carried out; still, they often look upon them as yet another burdensome regulatory requirement. But internal audits also offer a keen tool that can pare away not only noncompliant operations, but also inefficient or costly procedures. Read More
Roche has acquired Germany-based TIB Molbiol, a long-time partner on diagnostic products, and the company has just released three new tests that can differentiate mutations in the Omicron variant of the SARS-CoV-2 virus. Read More
The FDA is expanding the applications that can be made using its electronic Submission Template and Resource (eSTAR) filing system from 510(k) clearance requests to include de novo device applications. Read More
There are no one-size-fits-all methods for modeling cybersecurity threats facing medical devices, but developers and manufacturers of medical devices can help mitigate the threats by considering four simple questions suggests a new “playbook” endorsed by the FDA. Read More
There are several different triggers that prompt an investigation in a manufacturing facility. Deviations, quality events, unusual trends, out-of-specification (OOS) results, out-of-expected (OOE) results, complaints, adverse events, failures or rejections are some of the typical initiating situations. Read More
Medical device recalls increased by more than 35 percent to 235 incidents in the third quarter of 2021, up from just 173 in the second quarter, reversing a year-long trend of declining numbers, a new analysis suggests. Read More
Do you understand the FDA’s document access authority? Is your company’s data and documentation organized and ready for your next FDA inspection? If not, your next inspection could become a scavenger hunt. But that doesn’t have to be the case. Read More