Medical Devices Archives

Understanding FDA UDI Compliance Requirements for Medical Device Manufacturers

Medical Devices, Unique Device Identification

What are the potential consequences for medical device manufacturers not following through with product data...

Med Devices Missing in GUDID and Obsolete GMDN Codes in GUDID

Medical Devices, Unique Device Identification

Courtesy notification of news from FDA: The U.S. Food and Drug Administration (FDA) recently initiated two initiatives...

Reed Tech Takeaways from RAPS Euro Convergence

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

Greetings from Amsterdam! Earlier this month, Sales Development Representative Miriam Kniering represented Reed Tech...

LexisNexis Reed Tech teams up with RegDesk, a leading regulatory information management platform

Company News, Drug & Biologic Product Submissions, Medical Devices

Horsham, Pa., USA – May 25, 2023The collaboration of the leading providers of Unique Device Identification (UDI) for...

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 and Cosmetics

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 and Cosmetics

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.