Drug Master Files, manufacturer listings, and Electronic Common Technical Document (eCTD) submissions are foundational to regulatory compliance. Yet even experienced regulatory, quality, and operations...
The global Unique Device Identification (UDI) landscape is entering a critical enforcement phase — and 2026 will be a challenging year for medical device manufacturers operating in the European Union...
The FDA’s final rule, “Revising the National Drug Code Format and Drug Label Barcode Requirements,” establishes a uniform 12-digit format for FDA-assigned National Drug Codes (NDCs) ...
UDI product data is now due for specific scenarios (enforced as of December 8, 2022). Class I and Unclassified medical devices that are required to be labeled with a UDI code must submit product data...
LexisNexis Life Sciences Solutions and ONIX expand strategic alliance to guide pharma customers to market faster Professionals in the life sciences industry rely on unique regulatory affairs expertise...
It is critical to first determine if the software article is a Device Component, a Device Accessory, or a Standalone Device.
Software as a Medical Device (SaMD), however, is a Standalone Device technology intended to be used for medical purposes without being part of the hardware medical device, defined by the International Medical Device Regulations Forum (IMDRF). The software can quickly synthesize large amounts of data and the creator can enable adjustments to the medical device in real-time, due to the software’s connectivity to the internet.
IMDRF notes that SaMD can:
The US Food and Drug Administration (FDA) has published draft guidance, deemed as an “A-list” priority for FDA’s 2022 fiscal year, recommending documentation be included in premarket submissions for Software as a Medical Device. The documentation depends on four risk factors and must determine a submission’s documentation level as either Basic or Enhanced.
For Basic or Enhanced premarket submissions, FDA recommends the documentation include:
Unique Device Identification (UDI) information must be provided on all SaMD products, as stated by the FDA UDI Final Rule (reference: 21 CFR 801.20, 21 CFR 801.40, 21 CFR 801.50). There are some common UDI labeling requirements that apply to all SaMD products and, in addition, some special rules for SaMD products distributed electronically and in a physical form.
Changes identified by the manufacturer can be classified as either a Minor Change or Major Change. Minor Changes include a bug fix, usability enhancement, security patch, feature improvement (not a safety change) and does not require a new DI. These minor revisions are frequently identified by just a new Production Id (PI) or Catalog Number with the revised product considered another child in the same Major Version family.
A Major Change includes significant affecting specifications, performance, safety, intended use, performance, or effectiveness beyond the limits set by the Manufacturer and is considered a “new version or model” triggering a new DI. Major functional changes include different algorithms, database structures, architecture, new user interfaces, etc.
When comparing US FDA UDI requirements to EU EUDAMED UDI requirements, US FDA requires software DI and physical media DI to be the same (or different), downloaded software must use version as ‘Batch’ PI value and the UDI must be displayed in ‘About’ screen. EU EUDAMED UDI requires software DI and physical media DI to be the same.
Have questions about UDI requirements for Software as a Medical Device? LexisNexis Life Sciences can help.
Contact us