The FDA UDI Regulation will enact a single device identification system that is uniform, univocal, standardized, and globally coordinated. All Medical Device companies will be required to comply with the new UDI approach. While manufacturers stick to the UDI regulations, they will also have to exploit on the advantages of streamlining procedures through uniquely identifying and improving patient safety, attributions and procedures. Medical devices that are presumed critical are subject to this mandate, starting with the most critical (Class III) and ending with least critical (Class I) devices.
What is UDI?
A UDI (Unique Device Identification) system has the capability to improve the quality of data in medical device adverse event reports, which will help the FDA in correcting product problems more efficiently, better target product recalls and develop patient safety. The main objective of UDI is to update the GUDID (Medical Device Dictionary) where ad-hoc reports can be generated globally irrespective of various industrial factors.
Gearing up for the UDI Mandate
Enforcing UDI for medical devices is not an ordinary challenge, but every stage of the product manufacturing progression will use the same UDI making it easier, quicker and more effective to track any device through the supply chain process. Product recall management effectiveness will significantly increase when UDI tracking is fully implemented and will assure unsafe or ineffective devices should be repaired, removed or corrected in a timely manner.
Plan ahead for UDI Compliance with Sameva’s Value Added approach:
- Supporting companies in eSubmission Gateway Setups and providing guidance in creating validated GUDID HL7 SPL Submission Packages.
- Delivery of validated HL7 SPL Submission with documents in XML format as copies delivered to customers and uploaded to the FDA Electronic Submissions Gateway (ESG) accordingly.
- A Conversion Service report generated and delivered giving transparency to the approach and summary of tasks executed along with processing of all electronic submissions in our secured and validated environment.
- 360° maintenance of lifecycle of the product data as well as initial data validation, regulatory reviews and Change and Configuration Management in support of Global Unique Device Identification (GUDID) regulatory mandate.
- Centralized repository for collecting, collating and converting all the product/device information necessary for audit requests and regulatory submissions.
Schedule a discussion with our Subject Matter Expert and see for yourself how Sameva can assist your organization with FDA’s UDI Compliance and ensure conformance with current regulatory requirements and mandates, manage the supply chain, and reduction of product lifecycle time and time-to-market.