Description
The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, the nation’s food supply, cosmetics, dietary supplements, and products that give off radiation; and for regulating tobacco products.
Scope & Applicability
Product Classes
10Licensed IVDs subject to stability requirements
Devices subject to section 522 postmarket surveillance orders; devices subject to postmarket surveillance orders
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.
Medical device being tested in a clinical trial.; Medical devices intended for participants during the trial.
Guidance regarding the implementation of the custom device exemption; devices created or modified to comply with the order of an individual physician or dentist; Devices meeting specific criteria under section 520(b) for exemption; Devices created or modified to comply with the order of an individual physician; Devices exempt under specific FD&C Act provisions
Devices exempted from good manufacturing practice requirements
Low risk medical devices
Specific product category mentioned in 21 CFR 801.50
A product comprised of two or more regulated components.
Two or more different medical devices packaged together
Stakeholders
4Person who causes a label to be applied to a device for commercial distribution; Entity required to enter DI and attribute information into GUDID; Entity responsible for GUDID account and device information; Responsible for ensuring DI record information is accurate and up-to-date.; Entity identified by a GUDID account; Entity responsible for GUDID data and recordkeeping.
Target audience for the compliance guide.
Organization accredited by FDA to operate a UDI system; FDA-accredited organization that issues UDIs
Entity type with specific compliance dates
Regulatory Context
Attributes
4should be based on appropriate supportive stability data
Device characteristic affecting compliance dates
Device characteristic affecting compliance dates
Device characteristic affecting compliance dates
Identified Hazards
Hazards
1Material requiring specific labeling statement if contacting humans
Related CFR Sections (20)
- 21CFR1271.290§ 1271.290 Tracking.
(a) General. If you perform any step in the manufacture of an HCT/P in which you handle the HCT/P, you must track each such HCT/P in accordance with this section, to facilitate the investigation of actual or suspected transmission of communicable disease and take appropriate and timely corrective acRead full regulation →
- 21CFR803.32§ 803.32 If I am a user facility, what information must I submit in my individual adverse event reports?
You must include the following information in your report, if reasonably known to you, as described in § 803.30(b) . These types of information correspond generally to the elements of Form FDA 3500A:Read full regulation →
- 21CFR3.2§ 3.2 Definitions.
For the purpose of this part:Read full regulation →
- 21CFR812.3§ 812.3 Definitions.
(a) Act means the Federal Food, Drug, and Cosmetic Act (sections 201-901, 52 Stat. 1040 et seq., as amended ( 21 U.S.C. 301-392 )).Read full regulation →
- 21CFR801.20§ 801.20 Label to bear a unique device identifier.
(a) In general.Read full regulation →
- 21CFR830.350§ 830.350 Correction of information submitted to the Global Unique Device Identification Database.
(a) If FDA becomes aware that any information submitted to the Global Unique Device Identification Database (GUDID) appears to be incorrect or potentially misleading, we may notify the labeler of the specific information that appears to be incorrect, and request that the labeler provide corrected inRead full regulation →
- 21CFR830.320§ 830.320 Submission of unique device identification information.
(a) Designation of contact for device identification. Each labeler must designate an individual to serve as the point of contact with FDA on matters relating to the identification of medical devices marketed by the labeler. The contact for device information is responsible for ensuring FDA is providRead full regulation →
- 21CFR830.110§ 830.110 Application for accreditation as an issuing agency.
(a) Application for initial accreditation.Read full regulation →
- 21CFR830.100§ 830.100 FDA accreditation of an issuing agency.
(a) Eligibility. A private organization may apply for accreditation as an issuing agency.Read full regulation →
- 21CFR809.10§ 809.10 Labeling for in vitro diagnostic products.
(a) The label for an in vitro diagnostic product shall state the following information, except where such information is not applicable, or as otherwise specified in a standard for a particular product class or as provided in paragraph (e) of this section. Section 201(k) of the act provides that “a Read full regulation →
- 21CFR801.35§ 801.35 Voluntary labeling of a device with a unique device identifier.
(a) The labeler of a device that is not required to bear a unique device identifier (UDI) may voluntarily comply with § 801.20 . If a labeler voluntarily includes a UDI for a device, the labeler may voluntarily provide information concerning the device under subpart E of part 830 of this chapter .Read full regulation →
- 21CFR801.119§ 801.119 In vitro diagnostic products.
A product intended for use in the diagnosis of disease and which is an in vitro diagnostic product as defined in § 809.3(a) of this chapter shall be deemed to be in compliance with the requirements of this part and section 502(f)(1) of the Federal Food, Drug, and Cosmetic Act if it meets the requireRead full regulation →
- 21CFR801.57§ 801.57 Discontinuation of legacy FDA identification numbers assigned to devices.
(a) On the date your device must bear a unique device identifier (UDI) on its label, any National Health-Related Item Code (NHRIC) or National Drug Code (NDC) number assigned to that device is rescinded, and you may no longer provide an NHRIC or NDC number on the label of your device or on any devicRead 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 →
- 21CFR830.20§ 830.20 Requirements for a unique device identifier.
A unique device identifier (UDI) must:Read full regulation →
- 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 →
- 21CFR801.45§ 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 →
- 21CFR801.50§ 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 →
- 21CFR830.310§ 830.310 Information required for unique device identification.
The contact for device identification designated under § 830.320(a) shall provide FDA with the following information concerning each version or model of a device required to bear a unique device identifier (UDI) on its label: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 (10)
- 2025-12-09
CGMP/QSR/Medical Devices/Adulterated
Envoy Medical Inc.
- 2025-11-25
CGMP/QSR/Medical Devices/Adulterated
Hong Qiangxing Shenzhen Electronics Limited
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated
Contec Medical Systems Co., Ltd.
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Royal Philips
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Qianjiang Kingphar Medical Material Co Ltd.
- 2025-10-21
CGMP/QSR/Medical Devices/Adulterated
LEVO AG
- 2025-10-07
CGMP/QSR/Medical Devices/Adulterated
Technological Medical Advancements LLC
- 2025-09-23
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
The Richline Group, Inc.
- 2025-09-16
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
SeniorLife Technologies, Inc.
- 2025-08-26
CGMP/QSR/Medical Devices/Adulterated
Miach Orthopaedics
See Also (8)
- BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System: Guidance for Industry (Status: Final)
- Unique Device Identifier System: Frequently Asked Questions, Vol. 1 : 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)
- Global Unique Device Identification Database (GUDID): Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Unique Device Identifier Requirements for Combination Products: Draft Guidance for Industry (Status: Draft)
- Medical Device Reporting for User Facilities (Status: Final)
- Questions and Answers about eMDR - Electronic Medical Device Reporting - Guidance for Industry, User Facilities and FDA Staff (Status: Final)
- Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications (Status: Draft)