Explainer
FDA Device Labeling: 21 CFR Part 801
The Short Answer
What Part 801 Asks of Directions
Part 801 of Title 21 of the Code of Federal Regulations is titled Labeling and covers medical devices. For instructions, the rule that matters most is 801.5: adequate directions for use are directions under which the layman can use a device safely and for the purposes for which it is intended. The default is a lay user. The main way out is 801.109, for prescription devices that are not safe except under a licensed practitioner's supervision.
Two cautions before the detail. This page explains how the text is organized and is not legal or regulatory advice; read the current rule for your device. And it is the US view. The EU uses the term instructions for use under a different rulebook, covered in our eIFU briefing.
The Map
How Part 801 Is Organized
- Subpart A: general labeling
- Name and place of business (801.1), intended uses (801.4), adequate directions for use (801.5), misleading statements (801.6), prominence and symbols (801.15), the Puerto Rico Spanish provision (801.16), and the date format (801.18).
- Subpart B: unique device identification
- The labeling rules for the unique device identifier start at 801.20. They govern what the label and package carry, not how an instruction manual is written, and this page does not cover them.
- Subpart C: over-the-counter devices
- Label layout rules, starting with the principal display panel (801.60). They concern the package, not the instruction content.
- Subpart D: exemptions from adequate directions
- Prescription devices (801.109), devices with commonly known directions (801.116), in vitro diagnostic products (801.119), and devices for processing, teaching, or research (801.122, 801.125).
- Subpart H: specific devices
- Extra labeling content for named device types, such as prescription hearing aids (801.422), latex condoms, and devices containing natural rubber.
Part 801 is about what must appear in labeling. It does not say how to author, structure, or validate a manual. For the standard that covers the information a manufacturer supplies with a device, see ISO 20417 device information.
Section 801.5
Adequate Directions for Use
After the definition, 801.5 says directions may be inadequate because of omission, in whole or in part, or incorrect specification of any of these:
- Statements of all the conditions, purposes, or uses the device is intended for, including those it is advertised for or commonly used for
- Quantity of dose, including usual quantities for different ages and physical conditions
- Frequency of administration or application
- Duration of administration or application
- Time of administration or application in relation to meals, onset of symptoms, or other time factors
- Route or method of administration or application
- Preparation for use, such as adjustment of temperature or other manipulation or process
Two things follow for a manual. First, the list is written in the language of dosing and administration, and a device manual maps it onto its own subject: what the device is for, how to prepare it, how to use it, for how long, and how often. Second, the intended use is not only what the manual says. Section 801.4 defines it as the objective intent of the people legally responsible for the labeling, which may be shown by labeling claims, advertising matter, or statements. A manual that is silent on a use the company promotes elsewhere can still be inadequate.
Hazard wording sits alongside this. For how warnings, cautions, and notes are structured in practice, see warnings, cautions, and notes.
Prescription and Other Exemptions
Section 801.109 and the Rest of Subpart D
A device that is not safe except under the supervision of a licensed practitioner, so that adequate directions for use cannot be prepared, is exempt from the lay-user requirement if all the conditions in 801.109 are met. In short, the section asks for four things:
- The device is held by people in the manufacture and distribution chain or by a licensed practitioner, and is sold only to or on the order of such a practitioner.
- The label, other than for surgical instruments, bears the "Rx only" symbol statement or the "Caution: Federal law restricts this device" statement, and the method of its application or use.
- Labeling on or within the package from which the device is dispensed bears the information for use: indications, effects, routes, methods, frequency and duration, and the relevant hazards, contraindications, side effects, and precautions. It may be omitted from the dispensing package if, but only if, the directions, hazards, and warnings are commonly known to the practitioners who use the device.
- All labeling that furnishes information for use carries adequate information for practitioners, and labeling other than labels and cartons bears the date of issuance or of the latest revision.
The last point matters to anyone running a revision process: a dated, revision-marked document is part of the text, not a nice-to-have. The other exemptions in Subpart D are shorter. Section 801.116 exempts a device insofar as directions for common uses are known to the ordinary individual. Section 801.119 treats an in vitro diagnostic product as in compliance with Part 801 if it meets Subpart B and the requirements in 21 CFR 809.10. Sections 801.122 and 801.125 cover devices for further manufacture, and for teaching, law enforcement, research, and analysis.
Symbols, Language, Dates
Smaller Rules That Touch the Manual
Symbols. Section 801.15(c) lets required label and labeling content appear in English (or the predominant language of Puerto Rico or a Territory, for articles distributed solely there), as a symbol with adjacent explanatory text, or as a symbol without adjacent text under conditions. Those conditions are a symbol from a standard FDA recognizes, or one from a recognized standards development organization's standard, used as specified, and in both cases explained in a symbols glossary in the labeling. The package must carry a prominent statement saying where the glossary is. Symbols that do not meet these requirements render the device misbranded under the section.
Language. If the label or labeling includes any representation in a foreign language, all the required information must also appear in that language (801.15(c)(2) and (3)). Section 801.16 separately authorizes Spanish-only labeling of prescription-only devices distributed in Puerto Rico. Part 801 has no general translation requirement, so multi-language manuals follow from the markets you sell into; see instruction language requirements.
Dates. Printed dates meant to be brought to the user's attention use year, month, and day separated by hyphens (801.18). Identification. The unique device identifier rules are in Subpart B of Part 801 and in Part 830, and are outside the scope of this page.
Electronic Labeling
Where Part 801 Mentions Electronic
Within Part 801 itself, electronic delivery appears in two places. The symbols glossary under 801.15(c) may be paper or electronic. And 801.422(c)(2) requires the maker of a prescription hearing aid to include a user instructional brochure in the package and to make an electronic version available for download without site or customer registration and without requiring purchase of any product or service.
Beyond those, a text search of the part found no general rule that sets conditions for electronic-only instructions, unlike the EU, where implementing regulations set conditions for eIFU. That does not mean every path is open. Other parts of the regulations and FDA guidance can bear on electronic labeling, so read the rules for your device type. For what the EU conditions look like and how they change the document into a system, see the eIFU briefing. For a wider map of which rule applies to which product class, see legal requirements for user manuals, and for the technical file that sits beside the manual in the EU, see the technical file versus the user manual.
In Practice
A Checklist for Reading Part 801
- Decide who the device is for. The lay-user standard in 801.5 and the prescription exemption in 801.109 turn on that answer, and the answer comes from the intended use in 801.4, which includes your own advertising and statements.
- Pick the rule path and write it down: adequate directions for a lay user, the prescription device conditions, or another exemption such as 801.116 or 801.119.
- For a prescription device, check each condition in 801.109 against your package and your documents: the Rx statement, the method of use on the label, the practitioner information, and the revision date on the labeling.
- List every symbol on the label and in the manual, and check each against 801.15(c): adjacent text, or a symbol from the permitted standards with a glossary and a statement saying where the glossary is.
- Check the languages. Anything required on the label has to appear in each language the label uses.
- Check for a device-specific section in Subpart H, and for rules outside Part 801, before you call the content list complete.
FAQ
Questions We Hear
What does 21 CFR 801.5 say?
It defines adequate directions for use as directions under which the layman can use a device safely and for the purposes for which it is intended. It then lists seven things whose omission or incorrect specification can make directions inadequate: the conditions, purposes, or uses; quantity of dose; frequency; duration; time of administration; route or method; and preparation for use.
Do prescription devices need directions for lay users?
Not if the device meets the conditions in 21 CFR 801.109. The section covers a device that is not safe except under the supervision of a licensed practitioner, so that adequate directions for use cannot be prepared. It is exempt from the directions requirement if the conditions are met, including the prescription statement on the label and the practitioner-facing information in the labeling. Read the section for the full list.
Does Part 801 allow electronic instructions for use?
Part 801 has no general rule that sets conditions for electronic instructions the way EU implementing regulations do. Electronic delivery appears in specific places: a symbols glossary may be paper or electronic under 801.15(c), and 801.422(c)(2) requires an electronic version of the prescription hearing aid brochure to be available for download without registration or purchase. Check the rule for your device type, and for the EU side see our guide to eIFU.
What language does the labeling have to be in?
Under 801.15(c), required label and labeling statements appear in English, or in the predominant language for articles distributed solely in Puerto Rico or a Territory where it is not English, or as permitted symbols. If the label or labeling includes any representation in a foreign language, the required information has to appear in that language as well. Our guide to instruction language requirements covers the EU rules.
How is a date on a device label written?
Section 801.18 says a printed expiration date, date of manufacture, or other date meant to be brought to the user's attention is presented as a four-digit year, a two-digit month, and a two-digit day, separated by hyphens. January 2, 2014 is written 2014-01-02. The section lists exceptions, including combination products that properly bear a National Drug Code number.
Is this regulatory advice?
No. This page summarizes the regulation text as published in the eCFR to explain how it is organized. Whether and how a rule applies to your device depends on its classification, intended use, and market, so read the current text and take advice from a regulatory professional.
