Medical Device Labeling & Engraving
The FDA requires proper labeling for medical devices and equipment to ensure devices are used safely and effectively. With Sine-tific Solutions' medical device labeling services, we provide capabilities for high-quality, precision engraving, etching, and printing to meet the standards of identification and compliance set forth by the FDA. Explore medical engraving capabilities for the creation, design, and production with adherence to regulatory requirements that provide clear and accurate information to meet your needs.
Precision Medical Engraving and Labeling Capabilities
Medical device labeling provides essential information to health care professionals in medical environments, conveying instructions, calibration information, and asset identification. To provide the highest quality, fully compliant medical device labels, we offer years of industry experience and collaborate with you to find the optimal material and manufacturing process that meets application specifications. Sine-tific Solutions provides medical engraving using the following methods:
Applications of Medical Device Labeling and Engraving
The medical and pharmaceutical industries have various applications that require accurate and proper labeling of medical devices. Due to their importance, these labels must be resistant to fluids and chemicals. For medical device labels, engraved metals provide the most durability, meeting requirements for corrosion resistance and withstanding autoclave sterilization processing for high-quality, legible identification and instruction labels that meet your needs. Medical device labeling and engraving provide an ideal solution to applications, such as:
- Equipment labels
- Asset labels
- Instruction labels
- Data plates
- Calibration stickers
- ID tags
- Security labels
- Tamper-resistance labels
- Serialized/barcoded labels
General FDA Medical Device Labeling Requirements
The FDA outlines general medical device labeling requirements in 21 CFR Part 801, specifying the minimum standards for all devices and providing any additional requirements needed for specific categories of devices.
Name and Place of Business (21 CFR 801.1)
- The label of a device shall contain the name and place of business of the manufacturer, packer, or distributor, including the street address, city, state, and zip code.
- If the firm's street address is in the local telephone directory, the street address can be omitted.
- If the firm listed on the label is not the manufacturer, the firm information must be qualified by an appropriate statement such as "Manufactured for..." or "Distributed by..."
Intended Use (21 CFR 801.4)
- If a packer, distributor, or seller intends a device for uses other than those intended by the person from whom they received the device, these parties must furnish adequate labeling in accordance with the new intended use.
- If a manufacturer knows or has information indicating that this device is to be used for conditions or purposes other than which it was intended, he is required to provide adequate labeling in accordance with such other uses. (An example of this might be a manufacturer of dental X-ray equipment who is routinely selling his product to podiatrists.)
Adequate Directions (21 CFR 801.5)
"Adequate directions for use" means directions under which the layman can use a device safely and for the purposes intended. This includes:
- Statements of all purposes for which and conditions under which the device can be used;
- Quantity of dose for each use and usual quantities for persons of different ages and physical conditions;
- Frequency of administration;
- Duration of application;
- Time of administration in relation to other factors;
- Route or method of application; and
- Any preparation necessary for use.
Partner with Sine-tific Solutions for High-Quality Medical Engraving Services
With years of experience in the industry, Sine-tific Solutions offers a full suite of medical device labeling services to meet your unique requirements. Our capabilities deliver precise solutions, backed by on-time delivery and competitive rates for high-quality products, inviting our customers to return whenever they need our expertise. Combining an experienced production staff, dedicated outside sales engineers, and world-class customer service ensures complete satisfaction throughout engineering and production for precision medical device labels that are compliant with regulatory standards. Contact us to discuss your project specifications or request a quote to begin.
