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Unique Device Identification (UDI) and Product Data
Drug Label Research
Drug & Biologic Product Submissions
Recent Blog Posts
Status Update for Australia TGA UDI
The Australia Therapeutic Goods Administration (TGA) has announced several updates to the go-forward plan for implementing...
FDA Class I Medical Device UDI Due December 2022
Update on FDA Class I UDI as of July 22, 2022 Final guidance has been issued by the US Food and Drug Administration (FDA)...
HL7 Structured Product Labeling and the True Cost of the Free FDA Web Interface
Did you know? The FDA Class I deadline enforcement is occurring on December 8, 2022. Many in the medical device industry...
UDI Conferences In-Person September 2022
We are excited to be returning to 'in-person' conferences this September. Look for us at RAPS Convergence 2022 on...
What the EU EUDAMED Timeline Means for Your Product and What to Do Now
Update on the EU EUDAMED Timeline On 6 July 2022, the European Commission (EC) updated the publicly posted timeline...
What’s Been Happening with Health Canada XML PM Mandates?
Reed Tech recently presented a webinar to update customers with the most recent information about XML product monograph...
Preparing, Managing and Monitoring Medical Device UDI
In today’s ‘Coffee Talk’ we are chatting with Linda Morehouse, Account Executive with Reed Tech Life Sciences. Linda...
DIA Global Labeling Takeaways: Patient Materials and Health Literacy
Reed Tech habitually attends industry conferences and forums to share our expertise and gain knowledge from our industry...
LexisNexis® Reed Tech™ and Schlafender Hase® Alliance Provides Mutual Customer Benefits for Pharmaceutical and Medical Device Companies
HORSHAM, Pa., April 26, 2022 /PRNewswire/ -- Reed Technology and Information Services Inc. (Reed Tech™), a leading...
FDA Drug Distribution Amounts Report: Frequently Asked Questions and More
In late 2021, the US Food and Drug Administration (FDA) is instited a new annual distribution report, Reporting Amount of...
Public Dashboard Now Available for REMS Data
A new public dashboard has been launched by the Food and Drug Administration (FDA) for public access to data for drugs with...
Organizing and Finding Documents Easily for Medical Device Companies, Featuring Greenlight Guru
At Reed Tech Life Sciences, we know the challenges of locating and securing important documentation for both internal and...
How Can You Prepare for Unique Device Identification Product Data Submission in Asia?
Reed Tech subject matter experts, Gary Saner, Information Solutions Senior Manager and Patti Shragher, Medical Device Senior Account Executive and...
LexisNexis® Reed Tech and Greenlight Guru Announce Strategic Alliance to Guide Customers to Market Faster
LexisNexis® Reed Tech has teamed up with Greenlight Guru, the leading Medical Device Success Platform for medical device companies. Horsham, Pa.,...
How Does Software as a Medical Device Relate to Unique Device Identification?
Determining Software as a Medical DeviceIt is critical to first determine if the software article is a Device Component, a...
Missed FDA Annual Deadlines? It’s not too late to keep your drug active!
The Food and Drug Administration (FDA) requires drug manufacturers to keep their listings updated each year. Most of the...
Is My Product a Medical Device?
A frequent question on medical devices concerns determining ‘if’ a product is defined by US FDA as a ‘medical device’....
Updated Deadline: FDA Announces New Annual Drug Distribution Reporting Requirement
The Food and Drug Administration (FDA) has informed industry that the February 15, 2022 date for submitting 2020 data per...
What is a UDI label and UDI requirements?
What is UDI?Unique Device Identification is a globally unique, unambiguous identification comprised of a Device Identifier...
FDA Withdraws 216 ANDAs
Abbreviated new drug applications (ANDAs) are subject to complying with requirements of FDA annual reporting—often the Q4...
Overview of Pharma Annual Deadlines and Requirements
Each year pharmaceutical companies, including both manufacturers and private label distributors, are subject to numerous guidances and mandates to...
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