FDA labeling rules for medical devices

A device label must bear the name and place of business of the manufacturer, packer or distributor, a unique device identifier and adequate directions for use, with any date shown in the format required by § 801.18. What may be claimed is set by intended use: the labeling, advertising and other statements of the persons responsible for the article establish the uses for which directions and warnings must then be supplied.¹

Intended use and the limits on claims

Intended use refers to the objective intent of the persons legally responsible for the labeling of an article or their representatives. That intent may be shown by their expressions, by the design or composition of the article, or by the circumstances surrounding distribution. Labeling claims, advertising matter and oral or written statements are examples given in § 801.4. A firm’s knowledge that health care providers prescribe or use a cleared, approved, authorised or exempt device for another purpose does not by itself make the firm the intender of that unapproved new use.¹

Intended use can change after a device enters interstate commerce. A packer, distributor or seller may intend an article for uses other than those intended by the person from whom it was received. In that case, that packer, distributor or seller must supply labeling adequate for the new intended uses.¹

Device labeling may carry a representation that is false or misleading with respect to another device, or to a drug, food or cosmetic. Such a representation renders the device misbranded under § 801.6.¹

Adequate directions for use

Adequate directions for use means directions under which a layman can use the device safely and for its intended purposes. Section 801.5 treats directions as inadequate where they omit or misstate any of the following.

• the conditions, purposes or uses for which the device is intended
• the quantity of dose
• the frequency, duration and time of administration
• the route or method of application
• the preparation needed before use

The statement of uses covers purposes for which the device is prescribed, recommended or suggested in advertising and purposes for which it is commonly used.¹

Several exemptions from section 502(f)(1) of the Federal Food, Drug, and Cosmetic Act apply. A device is exempt where adequate directions for its common uses are known to the ordinary individual, under § 801.116. A device intended for processing, repacking or use in the manufacture of another drug or device is exempt if its label bears the statement “Caution: For manufacturing, processing, or repacking”, under § 801.122. A device subject to § 801.109 is exempt under § 801.125 when it is shipped to or held by persons lawfully engaged in non-clinical instruction in pharmacy or chemistry or medicine. The exemption also reaches such persons engaged in law enforcement or in non-clinical research or in chemical analysis or in physical testing.¹

Prescription devices

Section 801.109 exempts a prescription device from the requirement for adequate directions for use when the stated conditions are met. The device must be in the possession of a firm lawfully engaged in its manufacture or distribution, or of a licensed practitioner, and must be sold only to or on the order of such a practitioner. The label of the device, other than surgical instruments, must bear the symbol statement “Rx only” or ”℞ only”. It may instead bear the caution statement naming the class of practitioner. The label must also bear the method of its application or use in either case.¹

Labeling on or within the dispensing package must bear information for use. That information covers the following.

• indications
• effects
• routes, methods, frequency and duration of administration
• any relevant hazards, contraindications, side effects and precautions

It may be omitted from the dispensing package only where the directions, hazards and warnings are commonly known to practitioners licensed to use the device. Any labeling distributed by or on behalf of the manufacturer, packer or distributor that furnishes information for use must contain the same adequate information, and reminder-piece labeling that gives only the device name is outside this requirement. All labeling other than labels and cartons that bears information for use must show the date of issuance or of the latest revision.¹

At delivery to the ultimate purchaser, § 801.110 exempts a device subject to § 801.109 when a licensed practitioner delivers it in the course of professional practice or on a lawful order, with labeling bearing the practitioner’s name and address and the directions and cautionary statements in that order.¹

Over-the-counter device labels

For an over-the-counter device in package form, the principal display panel is the part of the label most likely to be displayed under customary conditions of retail display. Section 801.60 sets how the panel area is calculated for rectangular, cylindrical and other containers. Where a package bears alternate principal display panels, the required information is duplicated on each.¹

The principal display panel must bear a statement of identity as one of its principal features. Section 801.61 requires the common name of the device followed by an accurate statement of its principal intended actions, in bold face type and in a size reasonably related to the most prominent printed matter on the panel. Indications for use belong in the directions for use. Section 801.62 requires a declaration of net quantity of contents on the principal display panel, as a distinct item placed within the bottom 30 percent of the panel area, with an exception for panels of 5 square inches or less.¹

Prominence, language and symbols

Section 801.15 lists the ways a required statement can fail the prominence and conspicuousness required by section 502(c) of the act, including placement away from the panel displayed at purchase, small or crowded type and insufficient contrast. No exemption based on insufficiency of label space applies where the shortage arises from non-required matter, from giving other statements greater conspicuousness, or from use of label space for a foreign language.¹

Required words and statements must appear in English. The predominant language may be substituted for articles distributed solely in Puerto Rico or in a Territory where the predominant language is not English, and § 801.16 confirms that prescription devices labeled solely in Spanish for Puerto Rico are covered by that allowance. A symbol may be used with adjacent explanatory text. A symbol may stand without adjacent text where it comes from a standard FDA recognises under section 514(c) of the act, is used according to the specifications in that recognition and is explained in a paper or electronic symbols glossary included in the labeling. Symbols from other standards developed by a standards development organisation may also stand alone on the conditions set in § 801.15(c)(1)(i)(E), which include a manufacturer determination that the symbol is likely to be read and understood by the ordinary individual.¹

Dates and unique device identifiers

A printed expiration date, date of manufacture or other date intended for the attention of the user must be presented as four-digit year, two-digit month and two-digit day separated by hyphens. The example in § 801.18 renders 2 January 2014 as the year 2014, the month 01 and the day 02 separated by hyphens. Combination products properly bearing a National Drug Code number are excepted, as are dates of manufacture governed by § 1010.3(a)(2)(ii) for electronic products.¹

Section 801.20 requires the label of every medical device and every device package to bear a unique device identifier meeting subpart B and part 830. The UDI consists of a device identifier that identifies the version or model and the labeler, and a production identifier that conveys lot or batch, serial number, expiration date, manufacturing date or the distinct identification code for an HCT/P regulated as a device.¹

A device that must bear a UDI on its label must also carry a permanent direct marking if it is intended to be used more than once and reprocessed before each use. The direct marking may repeat the label UDI or use a different UDI to distinguish the unpackaged device. It may be given in plain text, by automatic identification and data capture technology, or both. Section 801.45(d) excepts devices where any direct marking would interfere with safety or effectiveness and where marking is not technologically feasible. It also excepts a single-use device subjected to additional processing for an additional single use and a device that has already been marked. A labeler relying on one of these exceptions must document the basis in the design and development files required by § 820.10(c).¹

Stand-alone software regulated as a device must present its UDI in plain text either whenever the software starts or through a menu command such as an “About” command. Software distributed outside packaged form is deemed to meet the UDI labeling requirements if it meets that display rule and conveys the version number in its production identifier. The same device identifier may be used for packaged and unpackaged distribution of the same software.¹

Warning statements required for particular devices

Part 801 subpart H imposes device-specific labeling. Devices composed of or containing natural rubber that contacts humans must bear the bold statement “Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.” on all labels and other labeling, including the principal display panel and the immediate package. Dry natural rubber and natural rubber in packaging carry their own prescribed statements. The term “hypoallergenic” may not appear on the labeling of any device covered by § 801.437.¹

Menstrual tampons must bear the toxic shock syndrome alert statement where the consumer information is supplied as a package insert, and the package label must bear one of the absorbency terms from light absorbency to ultra absorbency, matched to the measured ranges in § 801.430(e)(1). Latex condoms must display an expiration date prominently on the individual package and on higher levels of packaging, supported by the storage and integrity testing described in § 801.435(d). Over-the-counter devices containing or manufactured with class I ozone-depleting substances must carry one of the two warning statements in § 801.63. Eyeglasses and sunglasses must be fitted with impact-resistant lenses capable of withstanding the drop-ball test in § 801.410(d)(2), except where a physician or optometrist directs other lenses in writing and notifies the patient in writing.¹

In vitro diagnostic products

A product that meets the definition of an in vitro diagnostic product in § 809.3(a) is deemed to comply with Part 801 and with section 502(f)(1) of the act if it meets subpart B of Part 801 and § 809.10.¹ The label of an IVD must state the following, except where an item does not apply.

• The proprietary name and the established name.
• The intended use or uses of the product.
• For a reagent, the established name and quantity, proportion or concentration of each reactive ingredient, with source and activity for biological material.
• Warnings and precautions, the statement “For In Vitro Diagnostic Use” and other limiting statements, including “Rx only” for a prescription IVD.
• For a reagent, storage instructions adequate to protect stability.
• For a reagent, an expiration date, an observable indication of alteration or instructions for a simple user check.
• For a reagent, a declaration of net quantity of contents.
• The name and place of business of the manufacturer, packer or distributor.
• A lot or control number identified as such.²

Section 809.10(b) requires labeling accompanying each product, such as a package insert, to state specified information in one place and in the order given. The items are the proprietary and established names, the intended use and type of procedure, and a summary and explanation of the test. Next come the principles of the procedure, reagent information, instrument information, and specimen collection and preparation. These are followed by the procedure, results, limitations of the procedure, expected values and specific performance characteristics. The final items are a bibliography, the name and place of business of the manufacturer, packer or distributor, and the date of issuance of the last revision.²

Products shipped for investigations carry prescribed statements. A product in the laboratory research phase of development and not represented as an effective IVD bears “For Research Use Only. Not for use in diagnostic procedures.” A product shipped for testing before full commercial marketing bears “For Investigational Use Only. The performance characteristics of this product have not been established.”²

Analyte specific reagents are restricted devices under section 520(e) of the act. Their labeling follows § 809.10(e) and includes, for class I exempt ASRs, “Analyte Specific Reagent. Analytical and performance characteristics are not established”. Advertising and promotional materials for ASRs must carry the corresponding statement and may not make any statement regarding analytical or clinical performance. A laboratory that develops an in-house test using an ASR must append to the test report the statement that the test was developed by that laboratory and has not been cleared or approved by the Food and Drug Administration.²

Questions people also ask

Does every medical device label need a unique device identifier?

Section 801.20 states the general rule that the label of every medical device and every device package bears a UDI meeting subpart B of Part 801 and part 830. Exceptions are provided by §§ 801.30, 801.45 and 801.128(f)(2), and § 801.55 gives a route to request an exception or alternative that those provisions do not already supply.¹

What does “Rx only” replace on a prescription device label?

Section 801.109(b)(1) allows the symbol statement “Rx only” or ”℞ only” in place of the longer statement “Caution: Federal law restricts this device to sale by or on the order of a ___”, with the blank filled by physician, dentist, veterinarian or the designation of another practitioner licensed by the law of the State. The label must also give the method of application or use.¹

May labeling use graphical symbols without words next to them?

Yes, on conditions. A symbol may appear without adjacent explanatory text where it comes from a standard recognised by FDA under section 514(c) of the act and is used according to the specifications in the recognition, and where it is explained in a paper or electronic symbols glossary included in the labeling. The package labeling must bear a prominent statement identifying where the glossary is located. Section 809.10(g) sets equivalent conditions for in vitro diagnostic products, and use of symbols outside those conditions renders the device misbranded under section 502(c) of the act.²

How must dates appear on a device label?

The format required by § 801.18 is four-digit year, two-digit month and two-digit day, separated by hyphens. It applies to printed expiration dates, dates of manufacture and any other date intended to be brought to the attention of the user. Combination products bearing a National Drug Code number are excepted.¹

What must the labeling of general purpose laboratory reagents contain?

General purpose laboratory reagents and equipment whose uses are generally known to trained users need not bear the directions required by § 809.10(a) and (b) if their labeling meets § 809.10(d). The reagent label states the proprietary and established names, the ingredient declaration, a statement of purity and quality, warnings and the statement “For Laboratory Use”, storage instructions, net quantity of contents, the name and place of business, and a lot or control number.²

Footnotes

1. 21 CFR Part 801, Labeling. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801 ↩ ↩² ↩³ ↩⁴ ↩⁵ ↩⁶ ↩⁷ ↩⁸ ↩⁹ ↩¹⁰ ↩¹¹ ↩¹² ↩¹³ ↩¹⁴ ↩¹⁵ ↩¹⁶ ↩¹⁷ ↩¹⁸ ↩¹⁹ ↩²⁰ ↩²¹ ↩²² ↩²³

2. 21 CFR Part 809, In Vitro Diagnostic Products for Human Use. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-809 ↩ ↩² ↩³ ↩⁴ ↩⁵ ↩⁶