FDA’s UDI Draft Guidance Aims to Help with Rule Compliance
The agency clarifies the UDI rule for labelers and accredited issuing agencies.
Tag Archives: UDI
Eight Things You Need to Know about Unique Device Identification
Are you UDI-ready? Get the facts to achieve compliance fast.
Don’t Wait to Comply with UDI
The unique device identification rule is far more than just a labeling rule.
Need Help Navigating UDI? FDA Can Help
The agency has posted new education modules about the unique device identification rule.
Improving Compliance, Increasing Innovation
From increasing focus on reimbursement and economic value, to impact of UDI and the medical device user fees, three industry experts discuss current market and regulatory trends and challenges shaping the medical device industry, and offer some effective strategies for companies to follow to remain competitive.
From increasing focus on reimbursement and economic value, to impact of UDI and the medical device user fees, three industry experts discuss current market and regulatory trends and challenges shaping the medical device industry, and offer some effective strategies for companies to follow to remain competitive.
The Proposal: Marrying the Right Labeling Partner
Labeling is a top mission-critical business systems in medical devices; label documentation not only drives patient safety, but without it, there can be no product, revenue or profit. So how can better engagement, frank disclosure and shared long-term goals help medical device companies marry the right labeling partner?
Labeling is a top mission-critical business systems in medical devices; label documentation not only drives patient safety, but without it, there can be no product, revenue or profit. So how can better engagement, frank disclosure and shared long-term goals help medical device companies marry the right labeling partner?
UDI: What You Need to Know About Timelines, Compliance and Submissions
The legislated FDA Unique Device Identification regulation is a single device identification system that is invariable, absolute, standardized, and globally reconciled. All medical device manufacturers will be required to comply with the new UDI approach. Here’s some information for you to get started.
The legislated FDA Unique Device Identification regulation is a single device identification system that is invariable, absolute, standardized, and globally reconciled. All medical device manufacturers will be required to comply with the new UDI approach. Here’s some information for you to get started.
What Changes Should Manufacturers Expect From FDA?
With the advances in technology, FDA has higher expectations from manufacturers as data is more readily available. The integration of other technologies into a comprehensive MES system will drive costs down and quality up.
With the advances in technology, FDA has higher expectations from manufacturers as data is more readily available. The integration of other technologies into a comprehensive MES system will drive costs down and quality up.
