Labeling & Promotion Flashcards
What are the general requirements for medical device labeling according to 21 CFR Part 801?
Device labeling must include: manufacturer’s name and place of business, intended use, adequate directions for use (or appropriate exemption), and any relevant warnings or precautions. It must not be false or misleading in any particular way.
What is the difference between indications for use and intended use?
Intended use refers to the general purpose of the device or its function, while indications for use describes the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the target patient population.
What is a ‘reasonable patient/physician standard’ in terms of risk disclosure?
This standard requires disclosure of risks that a reasonable patient/physician would consider material to the decision to use a device. It’s used to determine if risk information is adequately communicated in labeling and promotional materials.
What is off-label promotion and why is it problematic?
Off-label promotion is the promotion of a medical device for uses not cleared or approved by regulatory authorities. It’s problematic because it circumvents the regulatory review process designed to ensure safety and effectiveness for each intended use, and can expose patients to untested risks.
What are the requirements for advertisements and promotional materials for prescription devices?
Advertisements and promotional materials must be truthful, not misleading, fairly balanced in presenting risks and benefits, consistent with approved labeling, contain adequate directions for use or required prescription statement, and include certain disclosure information.
What is a Unique Device Identifier (UDI) and what are its components?
A UDI is a unique numeric or alphanumeric code that consists of two parts:
1. Device Identifier (DI): identifies the device version or model and the labeler
2. Production Identifier (PI): identifies variable production information such as lot number, serial number, expiration date, or manufacturing date
What is the difference between contraindications and warnings in labeling?
Contraindications describe situations where the device should not be used because the risk outweighs any possible benefit (absolute prohibition). Warnings describe serious adverse reactions or potential safety hazards, along with steps to take if they occur.
What is required on the device label versus the package label?
The device label (directly affixed to the device) must include name and place of business of manufacturer, packer, or distributor, and may need to include the common device name. The package label must include this information plus adequate directions for use, warnings, and other required elements.
What is the Safe Medical Devices Act of 1990 and how did it affect labeling?
The Safe Medical Devices Act of 1990 enhanced FDA’s ability to monitor and evaluate device performance by requiring user facilities (e.g., hospitals) to report device-related adverse events to FDA. It also introduced requirements for tracking certain high-risk devices and authorized FDA to order recalls of dangerous devices.
What is the concept of “fair balance” in promotional materials?
Fair balance requires that the presentation of risk information is comparable in content, prominence, and readability to the presentation of benefit information in promotional materials. This helps ensure that healthcare providers and patients receive an accurate and complete picture of a device’s safety and effectiveness.
