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New FDA Requirement: New and Updated REMS Files to be Submitted in SPL Format

Drug & Biologic Product Submissions, Pharmaceutical and Cosmetics

As of December 28, 2022, all new REMS (Risk Evaluation and Mitigation Strategy) submissions and all REMS updates will be required to be submitted in SPL (Structured Product Labeling) format per the FDA. This is in compliance with the Final Guidance on REMS issued by FDA in late December 2020. This means that any current REMS registrations will not need to be submitted in SPL until they require updates. There are currently 62 active REMS—58 ETASU (Elements to Assure Safe Use) and 4 basic (non-ETASU.)

Class I UDI Inventory Exception: What You Need to Know about FDA Compliance

Medical Devices, Unique Device Identification

In 2013, the FDA granted a UDI exception for 3 years after the corresponding Compliance Date for finished medical devices manufactured and labeled without Unique Device Identification (UDI) as of the Compliance Date, commonly referred to as the 3-Year Inventory UDI Exception or the ‘Final Rule.’ Such devices meeting the criteria could be commercially distributed for 3 years after the corresponding Compliance Date without complying with UDI requirements. At the end of the 3-year period, any undistributed inventory would need to be reprocessed to comply with current UDI requirements, i.e., UDI Label and GUDID reporting.

Vision Expo West and Eyewear Industry UDI

Medical Devices, Unique Device Identification

Reed Tech Life Sciences representative Patti Shragher attended The Vision Expo West 2022 conference, on...

Combination Products: Regulatory Requirements and How To Comply

Drug & Biologic Product Submissions, Medical Devices, Pharmaceutical and Cosmetics, Unique Device Identification

Continue to be at the forefront of regulatory chatter. Our customers, both primarily medical device and primarily pharmaceutical, are regularly coming to us with questions surrounding this topic. Reed Tech answers these questions here in this blog post