Medical Devices Archives - Page 2 of 21

Drug and Device Corner December 2024

Dec 31, 2024 | Drug and Device Corner, Drugs, Medical Devices

The FDA issued a final rule establishing requirements for a nonprescription drug product with an Additional Condition for Nonprescription Use (ACNU). This new marketing pathway will allow the sale of a nonprescription drug product directly to a consumer once the user...

Drug and Device November 2024

Nov 25, 2024 | Drug and Device Corner, Drugs, Medical Devices

This is the final reminder that we are in the annual medical device facility renewal, drug establishment renewal, and listing certification period. All renewals and certifications must be completed by 31 December 2024. If you need help with your submissions, please...

21 CFR Part 11 and FDA Compliance

Nov 8, 2024 | Cosmetics, Dietary Supplements, Drugs, Foods, Medical Devices, On Demand Webinar

This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology

Drug and Device October 2024

Oct 28, 2024 | Drug and Device Corner, Drugs, Medical Devices

Reminder: We are now in the registration renewal period for both drug establishments and medical device facilities. Drug listing certifications must also be submitted between 1 October and 31 December annually. If you need assistance with the process, please contact...

Drug and Device September 2024

Sep 30, 2024 | Drug and Device Corner, Drugs, Medical Devices

The FDA Drug and Medical Device Registration renewal period begins 1 October 2024. With the drug listing certification period upon us, it is a good time to confirm your NDC listings are all accurate. Any NDC SPL file requiring updates should be done prior to 31...

FY2025 Medical Device Fees

Sep 9, 2024 | FDA and USDA Regulatory Update, Medical Devices

Please see below information regarding FY2025 Medical Device User Fees which go into effect 1 October 2024. Keep in mind, the FY2025 facility user fee must be paid prior to processing your annual renewal during the renewal period Oct 1 – Dec 31. FY2025 Medical Device...