Description
This guidancewas written prior to the February 27, 1997 implementation of FDA's Good Guidance Practices, GGP's. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be updated in the next revision to include the standard elements of GGP's.
Scope & Applicability
Product Classes
10Medical devices intended for human use; Approved or cleared medical devices
Validation of certain in vitro diagnostic devices (IVDs) for emerging pathogens; Validation of certain IVD devices for emerging pathogens
subject to additional labeling requirements under 1050.10
intended for use in sunlamp products
subject to requirements of 1040.20 including specific danger warnings
must comply with 1040.10 and additional measurement requirements
Any manufactured product or assemblage of components which constitutes, incorporates, or is intended to incorporate a laser or laser system
Laser classification requiring skin and eye exposure warnings
Laser classification requiring warning logotype B
Laser classification requiring specific irradiance-based labeling
Stakeholders
10Entity providing guidance documents upon request
Role ensuring FDA and GMP compliance
Executive marketing approval role
FDA staff member who advises on desk copies and coordinates presentations.
Role ensuring document adequacy for training
Role reviewing maintenance and repair information
Management role for engineering approval
Engineering role providing technical approval
Role managing the signature and approval flow
Role responsible for the labeling project
Regulatory Context
Attributes
8characterizing the safety of individual drugs
Information should be written at a level appropriate for those with less than a high school education.
Capability of radiographic equipment that may have an override
labels must remain legible under normal conditions of use
should be based on appropriate supportive stability data
Evidence of a new intended use based on communications
Evidence of benefit from everyday medical practice.
Directions allowing a layperson to use a device safely
Identified Hazards
Hazards
8risk associated with tampon use
Quality assurance check for adequate warnings
Injuries resulting from improper splint application due to labeling errors
can cause eye and skin injury, premature aging, and skin cancer
exposure risks requiring warnings and protective housing
Warning required for ports in cabinet X-ray systems
Risk from excess power application in certain tubes
Substances like hemolysis or hyperlipidemia that may affect system performance.
Related CFR Sections (20)
- 21CFR801.1§ 801.1 Medical devices; name and place of business of manufacturer, packer or distributor.
(a) The label of a device in package form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor.Read full regulation →
- 21CFR1040.20§ 1040.20 Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
(a) Applicability.Read full regulation →
- 21CFR1040.11§ 1040.11 Specific purpose laser products.
(a) Medical laser products. Each medical laser product shall comply with all of the applicable requirements of § 1040.10 for laser products of its class. In addition, the manufacturer shall:Read full regulation →
- 21CFR1010.2§ 1010.2 Certification.
(a) Every manufacturer of an electronic product for which an applicable standard is in effect under this subchapter shall furnish to the dealer or distributor, at the time of delivery of such product, the certification that such product conforms to all applicable standards under this subchapter.Read full regulation →
- 21CFR1040.10§ 1040.10 Laser products.
(a) Applicability. The provisions of this section and § 1040.11 , as amended, are applicable as specified to all laser products manufactured or assembled after August 1, 1976, except when:Read full regulation →
- 21CFR1020.30§ 1020.30 Diagnostic x-ray systems and their major components.
(a) Applicability.Read full regulation →
- 21CFR1020.20§ 1020.20 Cold-cathode gas discharge tubes.
(a) Applicability. The provisions of this section are applicable to cold-cathode gas discharge tubes designed to demonstrate the effects of a flow of electrons or the production of x-radiation as specified herein.Read full regulation →
- 21CFR1010.3§ 1010.3 Identification.
(a) Every manufacturer of an electronic product to which a standard under this subchapter is applicable shall set forth the information specified in paragraphs (a)(1) and (2) of this section. This information shall be provided in the form of a tag or label permanently affixed or inscribed on such prRead 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 →
- 21CFR820.40§ 820.40 [Reserved]
- 21CFR812.5§ 812.5 Labeling of investigational devices.
(a) Contents. An investigational device or its immediate package shall bear a label with the following information: the name and place of business of the manufacturer, packer, or distributor (in accordance with § 801.1 ), the quantity of contents, if appropriate, and the following statement: “CAUTIORead full regulation →
- 21CFR807.81§ 807.81 When a premarket notification submission is required.
(a) Except as provided in paragraph (b) of this section, each person who is required to register his establishment pursuant to § 807.20 must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for inRead full regulation →
- 21CFR801.150§ 801.150 Medical devices; processing, labeling, or repacking.
(a) Except as provided by paragraphs (b) and (c) of this section, a shipment or other delivery of a device which is, in accordance with the practice of the trade, to be processed, labeled, or repacked, in substantial quantity at an establishment other than that where originally processed or packed, Read full regulation →
- 21CFR801.125§ 801.125 Medical devices for use in teaching, law enforcement, research, and analysis.
A device subject to § 801.109 shall be exempt from section 502(f)(1) of this act if shipped or sold to, or in the possession of, persons regularly and lawfully engaged in instruction in pharmacy, chemistry, or medicine not involving clinical use, or engaged in law enforcement, or in research not invRead full regulation →
- 21CFR801.122§ 801.122 Medical devices for processing, repacking, or manufacturing.
A device intended for processing, repacking, or use in the manufacture of another drug or device shall be exempt from section 502(f)(1) of the act if its label bears the statement “Caution: For manufacturing, processing, or repacking”.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 →
- 21CFR801.116§ 801.116 Medical devices having commonly known directions.
A device shall be exempt from section 502(f)(1) of the act insofar as adequate directions for common uses thereof are known to the ordinary individual.Read full regulation →
- 21CFR801.110§ 801.110 Retail exemption for prescription devices.
A device subject to § 801.109 shall be exempt at the time of delivery to the ultimate purchaser or user from section 502(f)(1) of the act if it is delivered by a licensed practitioner in the course of his professional practice or upon a prescription or other order lawfully issued in the course of hiRead full regulation →
- 21CFR801.109§ 801.109 Prescription devices.
A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” canRead full regulation →
- 21CFR801.62§ 801.62 Declaration of net quantity of contents.
(a) The label of an over-the-counter device in package form shall bear a declaration of the net quantity of contents. This shall be expressed in the terms of weight, measure, numerical count, or a combination of numerical count and weight, measure, or size: Provided, That: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)
- Device Labeling Guidance #G91-1 (Blue Book Memo) (Status: Final)
- Slit Lamp Guidance - Guidance for Industry (Status: Final)
- Guidance Document For Nonprescription Sunglasses - Guidance for Industry (Status: Final)
- Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants - Guidance for Industry and FDA Reviewers (Status: Final)
- Guidance Document for the Preparation of IDEs for Spinal Systems - Guidance for Industry and/or FDA Staff (Status: Final)
- Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals: Final Guidance for Industry and FDA (Status: Final)
- Impact-Resistant Lenses: Questions and Answers: Guidance for Industry and FDA Staff (Status: Final)
- Custom Device Exemption: Guidance for Industry and Food and Drug Administration Staff (Status: Final)