Description
FDA has updated this guidance to include FDA’s compliance policy regarding Global Unique Device Identification Database (GUDID) submission requirements for certain class I devices considered consumer health products. Specifically, FDA does not intend to enforce the GUDID submission requirements under 21 CFR 830.300 for class I devices considered to be consumer health products that are required to bear a UDI on their labels and device packages. Additionally, FDA does not intend to enforce the GUDID submission requirements under 21 CFR 830.300 for class I and unclassified devices, other than implantable, life-supporting, or life-sustaining (I/LS/LS) devices, regardless of whether they are consumer health products, before December 8, 2022 (an additional 75 calendar days).
Scope & Applicability
Product Classes
10Low risk medical devices
Compliance dates and policies for unclassified devices; pre-amendments device type for which a classification regulation has not been promulgated
Generally recommended for Enhanced Documentation; Regulatory classification mentioned for implantable sensors and HPV tests; Mentioned in the context of an in vitro nucleic acid test for CMV DNA.
Devices subject to section 522 postmarket surveillance orders; devices subject to postmarket surveillance orders
Implantable, life-supporting, or life-sustaining devices
Subject to UDI compliance date policies
510(k)-exempt class I devices sold directly to consumers over-the-counter
Class I devices not exempt from 510(k) notification; devices for which information is available on FDA website
devices restricted to sale, distribution, or use upon authorization
Telephone follow-up after surgery
Stakeholders
2Person who causes a label to be applied or modified; The entity responsible for submitting information to GUDID.; Entity responsible for identifying device constituent parts
Use of local healthcare professionals (HCPs) and facilities.
Regulatory Context
Attributes
1Condition for devices manufactured and labeled prior to compliance dates
Related CFR Sections (10)
- 21CFR801.18§ 801.18 Format of dates provided on a medical device label.
(a) In general. Whenever the label of a medical device includes a printed expiration date, date of manufacture, or any other date intended to be brought to the attention of the user of the device, the date must be presented in the following format: The year, using four digits; followed by the month,Read full regulation →
- 21CFR801.20§ 801.20 Label to bear a unique device identifier.
(a) In general.Read full regulation →
- 21CFR801.50§ 801.50 Labeling requirements for stand-alone software.
(a) Stand-alone software that is not distributed in packaged form (e.g., when downloaded from a Web site) is deemed to meet the UDI labeling requirements of this subpart if it complies with the requirements of paragraph (b) of this section and conveys the version number in its production identifier.Read full regulation →
- 21CFR830.300§ 830.300 Devices subject to device identification data submission requirements.
(a) In general. The labeler of a device must provide the information required by this subpart for each version or model required to bear a unique device identifier (UDI).Read full regulation →
- 21CFR801.45§ 801.45 Devices that must be directly marked with a unique device identifier.
(a) In general. A device that must bear a unique device identifier (UDI) on its label must also bear a permanent marking providing the UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.Read full regulation →
- 21CFR801.3§ 801.3 Definitions.
As used in this part:Read full regulation →
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
- 21CFR801.40§ 801.40 Form of a unique device identifier.
(a) Every unique device identifier (UDI) must meet the technical requirements of § 830.20 of this chapter . The UDI must be presented in two forms:Read full regulation →
- 21CFR860.3§ 860.3 Definitions.
For the purposes of this part:Read full regulation →
- 21CFR801.30§ 801.30 General exceptions from the requirement for the label of a device to bear a unique device identifier.
(a) In general. The following types of devices are excepted from the requirement of § 801.20 ; a device within one or more of the following exceptions is not required to bear a unique device identifier (UDI):Read full regulation →
Related Warning Letters (4)
- 2025-10-21
CGMP/QSR/Medical Devices/Adulterated
LEVO AG
- 2025-05-20
CGMP/QSR/Medical Devices/Adulterated
NeuroSync, Inc.
- 2024-10-29
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Argon Medical Productions & Vertrieb Gesellschaft MBH & CO
- 2023-11-14
CGMP/QSR/Medical Devices/Misbranded
Wello Inc.
See Also (8)
- Unique Device Identification System: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Unique Device Identification: Direct Marking of Devices : Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings - Labeling Considerations: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI): Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Unique Device Identification: Convenience Kits : Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Global Unique Device Identification Database (GUDID): Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- Unique Device Identifier Requirements for Combination Products: Draft Guidance for Industry (Status: Draft)