UDI Insights & Updates

Medical Device Standards and Regulations

FDA Regulations

🔗 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820

🔗 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-803

🔗 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-803

Stay informed with the latest updates, regulatory changes, and practical guidance on UDI implementation for medical devices in the U.S. market.

At AYM Consulting Services LLC, we monitor FDA UDI regulations and trends to help manufacturers stay compliant and ahead of the curve.

🔗 21 CFR Part 830

🔗 21 CFR Part 801

🔗  21 CFR Part 803

🔗 21 CFR Part 806

🔗 21 CFR Part 807  

🔗 GUDID Guidance Documents

🔗 UDI Compliance Dates by Class

What: Explains how UDI requirements apply to combination products (products that include a device constituent part).
Why it matters: Clarifies when a device constituent part must carry a UDI and how to submit those records to GUDID.
Source: Federal Register / 🔗 FDA (draft guidance announced June 2025

Updated GUDID guidance (final guidance — updated)

What: FDA published an updated final guidance for submitting UDIs to the Global Unique Device Identification Database (GUDID), replacing earlier guidance (June 2014). Notable updates include removing FDA Preferred Terms (FDA PT) from GUDID and other technical clarifications.
Why it matters: Affects how labelers must prepare and submit device records to GUDID (fields, nomenclature expectations, and record maintenance).
Source: 🔗 FDA guidance page and industry coverage (Dec/Jan update reported).

What: Final guidance describing compliance dates and FDA policy regarding GUDID submission requirements for certain devices (including Class I/consumer health products) and direct marking expectations.
Why it matters: Tells manufacturers which device classes and exceptions are subject to current compliance dates and which GUDID submissions are required or deferred. Useful for classifying obligations.

Device category	UDI on label / GUDID submission — Compliance date	Direct-marking (if required for intended use) — Compliance date	Notes / enforcement policy
Class III devices (including devices licensed under the PHS Act)	September 24, 2014	September 24, 2016	Dates come from UDI final rule; direct-mark policy described in FDA guidance.
Implantable / Life-Supporting / Life-Sustaining (I/LS/LS) devices	September 24, 2015	September 24, 2015	I/LS/LS devices phased earlier due to statutory two-year requirement.
Class II devices (other than I/LS/LS)	September 24, 2016	September 24, 2018	Labeling/GUDID date = 2016; direct-mark obligations for some Class II devices phased to 2018.
Class I and Unclassified devices (other than I/LS/LS) — labeling & date formatting	September 24, 2018	September 24, 2020 (enforcement discretion applied)	FDA issued guidance delaying enforcement for GUDID submission and direct marking.
Class I — GUDID submission enforcement policy	Varies — No enforcement before Sept 24, 2022; extended to Dec 8, 2022 for non-consumer-health Class I devices	No enforcement before Sept 24, 2022	Class I consumer health products exempt from some GUDID requirements; check FDA guidance.

Source: 🔗 FDA UDI compliance policies and compliance dates guidance (posted July 22, 2022; still the operative policy reference).

What: The original UDI Rule (final rule, Sept 24, 2013) codified in CFR — establishes labeling requirements (placement, content) and GUDID submission obligations.
Why it matters: The legal/regulatory backbone for all UDI work — always refer to these CFR provisions for mandatory requirements.
Source: 🔗 Federal Register / CFR citation (UDI final rule).

 FDA’s UDI Homepage

 GUDID User Manual and Quick Reference Guides

 Sample UDI Label Templates