FDA ESTABLISHES A NEW DIGITAL HEALTH ADVISORY COMMITTEE
The world of technology is moving at lighting speed. We are experiencing advances in software capabilities, interactions with automated services, and a far greater emphasis on how we are becoming more reliant on digital processes in our everyday lives. Case in point, when was the last time you were able to actually talk to a […]
FDA UPDATE: FINAL GUIDANCE SUBMISSION AND REVIEW OF STERILITY INFORMATION IN PREMARKET NOTIFICATION (510(K)) SUBMISSIONS FOR DEVICES LABELED AS STERILE
On Jan. 8, 2024, the FDA updated the final guidance on “Submission and Review of Sterility Information in 510(k) Submissions for Devices Labeled as Sterile”. Within the document, the FDA announces that it has recategorized vaporized hydrogen peroxide (VHP) to be an Established Category A sterilization process. As such, this places VHP in the same […]
