A medical device can range from the simplest household item found in everyone’s pantry, like a band-aid, to more complex technology like an x-ray machine. Regardless of its complexity, there is a constant amongst them all. They all need to be tested and approved to meet FDA requirements and compliance.
While there is a long list of requirements to meet to even be classified as a medical device by the FDA, once labeled, there are strict rules and regulations put in place to ensure its proper use along with patient and consumer safety. These rules surround all documentation associated with the device, including labels, packaging, and technical documentation.
A long and tedious process, FDA labeling requirements for medical devices is rigorous for good reason. The detrimental consequences that can come with the improper use of devices are extremely high risk and companies make sure to take every precaution possible to avoid irreversible and potentially permanent problems.
One way medical companies ensure the safety and quality of their products is through precise checks, reviews, and thorough proofreading. Every aspect of the device is inspected and reviewed to ensure no mistakes have slipped through and that the final product is error-free.
Yet, when companies rely on manual methods as their primary approach to proofreading and quality control, they are increasing their chances of producing faulty products, labels, and packaging, due to the heightened likelihood of human error.
Luckily, pharmaceutical companies and medical device manufacturers don’t have to rely on manual methods anymore to ensure their label and content accuracy. They can now turn to automated quality control as their secret to flawless labels, artwork, and products.
Types of Medical Devices and Their Regulations
Medical devices can range from simple to complex. Regulatory authorities globally have put into place risk classifications that group devices into categories based on their potential harm if misused, the complexity of the device, and certain use characteristics.
These classifications are essential to ensure safety and ease the marketing and placement of devices. It also sets a standard for testing where officials know, according to classification, how much testing a device needs to undergo to be deemed safe and ready for patient use.
Medical Device Classification
In the United States, the FDA has classified medical devices into three categories based on the level of control needed to ensure the safety of use. The classifications are:
- Class I - Low risks: Includes devices such as bandages, toothbrushes, floss, and hospital beds. Only requires general controls.
- Class II - Medium Risk: Includes contact lenses, pregnancy tests, and catheters. Requires general controls as well as pre-market notifications
- Class III - High Risk: Includes respirators, prosthetics, and pacemakers. Requires all general controls along with special controls and pre-market approval.
Regulations and Standardizations
Regardless of their classification, it's important that all medical devices adhere to a certain set of regulations and standardizations. Much like pharmaceuticals, medical devices are treated with similar rigor and are highly regulated.
The FDA offers a detailed overview of all the regulations devices need to follow in order to be deemed fit for use by the general public. The International Organization for Standardization (ISO) sets the standards and convenes them for ease of implementation in the industry.Some regulations that are put in place for medical devices include:
- Establishment registration
- Medical device listing
- Pre-Market notification
- Pre-Market approval
- Quality system regulation
- Labeling
- Medical device reporting
Labels and Labeling
The FDA defines a label as a “display of written, printed, or graphic matter upon the immediate container of any article” or “all labels and other written, printed, or graphic matter.”
As such, labels are the first point of contact for information for many medical practitioners, patients, and consumers, and need to be accurate to avoid confusion or life-threatening consequences. The FDA breaks down label regulations and clearly defines them by the following:
- General device labeling
- Use of symbols
- Unique device identification
- Good manufacturing practices
- General electronic products
These regulations are in place to primarily ensure that the products and devices in question are being used as they are intended and that the safety of those using them is guaranteed.
Keeping up with these regulations is already an extremely complicated process, but simplifying workflows and streamlining processes to increase efficiency is very much possible.
Once you ensure that your medical device labelings are following all regulations and standardizations how can you ensure that the written, printed, and graphic matter of your products are error-free?
A document comparison tool is the natural next step in your regulation and standardization process that enhances your labels and artwork and makes keeping up with regulations easy. In a fraction of the time, you will be able to check and inspect entire files and documents and increase the accuracy of labels while easing the FDA labeling requirements put in place for medical devices.
Making FDA Labeling Requirements a Breeze
While traditionally manual checks were the method by which medical device labels, packaging, and graphics, were inspected, in today’s modern, globalized markets, demand is too large to rely on outdated methodologies.
Devices and accompanying content are being produced at such rates and numbers that companies need to turn to technology to help ensure the accuracy of their products along with all technical documentation.
In other words, a text comparison tool is the ideal solution they are looking for.
A text comparison tool proofreads documents and files in seconds. The software works by overlaying two files to find discrepancies between the two. No matter how small the errors or differences may be, the software will detect them and pinpoint their exact location on the file.
The software can detect errors in copy and artwork that is nearly impossible to see with the naked eye. Using a document comparison tool, errors and differences can be easily found in text, graphics, barcodes, braille, print, and color.
The result is proofread and error-free labels and packaging in record time - every time.
To avoid unnecessary and hasty product mistakes that can be easily corrected and avoided, introduce text comparison technology to your workflows to ensure your medical device labelings reach the hands of consumers in pristine condition - down to the last period.
Ready to Simplify Your Processes?
In an already complicated and highly regulated industry, keeping up with regulations can be complicated and hard to follow.
Pharmaceutical companies and medical device manufacturers should search for solutions to help ease the FDA labeling requirements for medical devices while simultaneously increasing the accuracy of their labels and the efficiency of creating and printing them. Through the use of the right technology, such as text comparison technology, companies and manufacturers can see increased benefits in their workflows that result in better and more accurate products.
Using trusted automated proofreading technology like GlobalVision, companies in regulated industries can automate their quality control and get products to market faster, with complete confidence.
To learn more about file comparison technology and how it can benefit your company, request a demo of GlobalVision today!
Related Articles:
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- Your Complete Guide to Meeting FDA Labeling Requirements
- How to Ace FDA Food Label Compliance Review: Ensure Your Labels are Always Approved
- Ensure Your Labels Meet all FDA Drug Labeling Requirements with Automated Quality Control
- Overcome Your Content Challenges in Cosmetic Labeling to Meet FDA Requirements
Ensure your content is always error-free in record time with GlobalVision. Try it now for free.
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