Description
(2) to assist Center reviewers in their review and evaluation of medical device patient labeling to help make it understandable to and usable by patients (or family members or other lay persons caring for patients).
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
8This labeling may pertain to therapeutic, restorative, diagnostic, or cosmetic devices.
Referenced in studies regarding warning labels
Example of an acronym (HME) that should be defined.
bone plates, screws, and washers categorized as prescription devices
Example of a primary device used by patients.
The use of phantoms may also be appropriate for the assessment of certain diagnostic devices
Devices that would have patient labeling consisting primarily of risk/benefit information.
FDA intends to assess device cybersecurity based on a number of factors; demonstrate or maintain its safety and effectiveness; ensuring cybersecurity has become essential to FDA’s ability to protect the public health; Cyber-resiliency capabilities for medical devices
Stakeholders
10Intended user population for emergency use auto-injectors
intended users in an over-the-counter use scenario
target audience for prescribing information
For elderly or visually impaired users, use at least 14 points.
For elderly or visually impaired users, use at least 14 points.
Intended users such as nurses in a nonemergency setting
A professional who may perform complex maintenance.
Entity required to conduct postmarket surveillance; entity responsible for submitting postmarket surveillance plans; Entity holding the approved PMA, HDE, or cleared 510(k); The entity responsible for conducting postmarket surveillance and submitting reports.; Entity that can use the checklist as a reference for submissions.
to assist Center reviewers in their review and evaluation
individual receiving expanded access treatment; The individual receiving the investigational treatment and providing consent.
Regulatory Context
Regulatory Activities
1A medical device submission type (510(k)).
Document Types
10Medical device patient labeling is any information associated with a device targeted to the patient; Supplied in many formats, for example, as patient brochures, patient leaflets, user manuals, and videotapes.; The primary document being discussed for lay users.; The primary document being discussed for patient use.; The document provides principles for clear, concise writing in medical device patient labeling.; Don't promote the product in the medical device patient labeling.; The primary docum
Document containing warnings and instructions
CDRH General Program Memorandum #G91-1
SEC handbook for creating clear disclosure documents
A qualitative research report on labeling needs
HHS Publication FDA 93-4258; 1993; HHS Publication FDA 93-4258 regarding labeling
Additional Information includes warranty
Specific type of documentation where tables and graphs are normally not appropriate.
Read the instruction manual before using this device.
Include a summary page with critical information for lengthy labeling.
Attributes
10FDA believes that modifications included in a PCCP should also maintain the device within the device's indications for use.
User's understanding of risk based on labeling
Characteristic affecting the likelihood of reading warnings
Content recommendation for patient labeling
Determines the order of topics in the counseling section.
Terms like WARNING or CAUTION used to alert the reader.
Recommended formatting for ease of reading.
Used to keep labeling from looking too cramped or spread out.
Number each step in Arabic numbers such as 1, 2, 3.
Use a serif font for the text.
Technical Details
Substances
1Mercury is toxic.
Testing Methods
10Appendix F Pretesting; Systematically gather target audience reactions through focus groups.; systematic gathering of target audience reactions before final issuance; The medical device patient labeling adheres to the guidance recommended for pretesting; Developing and testing materials before finalization
Cloze Procedure: a new tool for measuring readability
SMOG grading - a new readability formula
method of pretesting labeling
method of pretesting labeling involving 8 to 10 people
method of pretesting labeling
tools that predict but do not measure actual comprehension
Assessment of jargon, organization, and style to enhance comprehension.
Quantitative tools used to predict the reading level of text.; The place of readability formulas in technical communication; Methods used to evaluate the complexity of printed materials
Procedures specify the steps for establishing calibration intervals
Processes
4Labeling should describe steps for implantation
Example of a process that might cause damage if not handled with precaution.
Intended use of soft contact lens care products
Procedures required for safety and effectiveness such as calibration.; Operating Information includes checkout procedures
Clinical Concepts
7Information required in labeling for medical products
Example of a nature of hazard statement.
The most common side effects which may occur with PROPRIETARY NAME include: <list adverse reactions here>.
result of inadequate consumption of calcium and vitamin D; Adverse health effect from inadequate nutrient intake.
Safety events that must be tracked for different updates
Included in the definition of immunotoxicity
Reactions or events observed in patients; Information described in an ICSR; Information associated with the use of biopharmaceuticals; Clinical information corrected during an amendment; Section D describes the singular subject who experienced one or several adverse events/reactions.; Reactions or events observed in patients or foetuses; The onset of a reaction/event following drug administration.; Reporting of reactions to suspect drugs; Reaction or event reported by the primary source; Reactio
Identified Hazards
Hazards
10balanced presentation of adverse events and the risks and benefits of the device; Labeling informs patients about proper use, risks, and benefits.; Risks and benefits
General safety concerns addressed by ANSI standards
one of the four elements of an effective hazard alert
one of the four elements of an effective hazard alert
The severity level associated with a precaution.
The severity level associated with a warning.
call the local authorities for help with the mercury spill
Dampness may affect the device and cause rust.
Technical reason for PRO non-completion.
List known and reasonably foreseeable hazards in the labeling.
Standards & References
External Standards
1Standard cited for the definitions of warnings and precautions.; American National Standard for Product Safety Signs and Labels
Related CFR Sections (1)
- 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 →
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
See Also (8)
- Product Labeling for Laparoscopic Power Morcellators: Guidance for Industry and Food and Drug Administration Staff
- Postmarket Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff
- Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH): Guidance for Industry and Food and Drug Administration Staff
- Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions: Guidance for Industry and Food and Drug Administration Staff
- Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff
- Minimizing Risk for Children's Toy Laser Products: Guidance for Industry and Food and Drug Administration Staff
- Investigational IVDs Used in Clinical Investigations of Therapeutic Products: Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards
- Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff