Medical Devices Archives

EU Amendment to Extend Legacy Medical Device Transition

Medical Devices, Unique Device Identification

In recent news, the European Commission passed an extension (EU Regulation 2023/607) to the transition deadline for...

What the EU EUDAMED Timeline Means for Your Product and What to Do Now

Medical Devices, Unique Device Identification

Update on the EU EUDAMED Timeline On 6 July 2022, the European Commission (EC) updated the publicly posted timeline...

Coffee Talk with Reed Tech – EU EUDAMED Testing Update

Medical Devices, Unique Device Identification

In the latest edition of 'Coffee Talk', Reed Tech UDI experts, Gary Saner (Sr. Manager of Information Solutions) and...

Simplifying Annual Drug Sample Reporting

Drug & Biologic Product Submissions, Drug Label Research, Pharmaceutical

Pharma manufacturers and authorized distributors need to submit distribution reports electronically in an eXtensible Markup Language (XML) format to comply with the guidance entitled Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act. This guidance fulfills the Drug Sample Transparency Act specification of ACA Section 6004. These amounts must be reported each year by April 1st for the previous calendar year.

MoCRA: The Future of Cosmetic Regulations

Drug & Biologic Product Submissions, Drug Label Research, Pharmaceutical

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was signed into law on December 29, 2022. This law, which provides a major overhaul of existing cosmetic regulations, requires the Food and Drug Administration (FDA) to create Good Manufacturing Practices for all cosmetics manufacturers. The law states that these established practices must include mandatory reporting of serious adverse health events caused by cosmetic products and mandatory testing of asbestos levels. This law will also include updates to cosmetic listing requirements.