Laser Marking for Medical Devices: FDA Certification Requirements and Implementation

The laser marking of medical products must meet the strict requirements of the US Food and Drug Administration. This course will examine the key points of compliance and the FDA's certification process, covering such issues as material selection, content standards, and environmental controls. It will help companies to efficiently pass the certification process and ensure that their products are legal.

Why must laser marking in the medical field pay attention to FDA certification?

Laser marking of medical equipment is not only a basic process for identifying products, but it is also a key point of focus for FDA regulation.Whether they are used in implants or external diagnostic devices, laser markings have a direct impact on product traceability and patient safety.If the information on the labels is unclear or falls off, the worst case scenario is that it could cause a legal risk.Therefore, don't think that it's "just a matter of putting a label on it." The FDA is quite strict about this.

This is the core requirement of the FDA's certification process.

The materials must be compatible.

Different kinds of medical equipment (such as titanium alloy orthopedic implants and plastic disposables) respond very differently to laser wavelength and energy.In the second phase, the FDA will focus on checking whether the material's properties change after being marked. For example, does the high temperature cause the material to become brittle or to release harmful substances?It is recommended that a small batch of products be tested to ensure that the marking does not adversely affect the biocompatibility of the material.

The content of the signs needs to be clear and memorable.

The FDA clearly requires that the information on the label be legible for the life of the device.For example, for long-term implants such as stents, the depth of the marking and the surface oxidation treatment must ensure that the UDI code remains readable even after years of friction or exposure to bodily fluids.The contrast between the background and the characters should be as high as possible.

The production environment and the recording process must not break down.

Even if the labeling equipment is state of the art, if the temperature or humidity in the workshop is out of control, or if the operators don't follow the procedures, the FDA will still find nonconformities.Especially for the production line for sterile instruments, the number of dust particles and the results of microbial monitoring in the marking area must be recorded in real time, and not just added to the records in a rush before the audit.

Three steps to FDA approval.

The first step is to clearly define product categories and standards.

First, check to see which class (Class I, II, or III) your product belongs to under the FDA's classification system. The requirements for marking are very different for each class.For example, Class III devices require a complete report on process validation, but Class I non-contact devices may only need to provide basic test data.

Step 2: Prepare technical documents.

In addition to the usual equipment parameters and process flow charts, technical documentation must include an accelerated aging test report for the marked samples.I've seen many companies that have sent fresh samples for testing, only to be told that they have to redo the aging experiment for six months, which wastes a lot of time.

Step three: Simulated review.

Before submitting it, it is recommended that the company carry out an internal mock audit based on the FDA's QSR820 system.The key is to check the records of changes in the procedures for labeling. For example, if a laser lens was replaced on a certain day, was the process re-confirmed? These details are often “ hidden points ” that external consulting firms do not remind people of.

Frequently Asked Questions.

Q: If a product already has CE certification, is it necessary to get FDA certification?

Although both the CE mark and FDA have requirements for device identification, the FDA is particularly concerned about the compatibility of UDI codes.For example, the size of the DataMatrix code that the EU accepts may not meet the FDA's minimum resolution requirements, so the parameters of the marking process must be adjusted.

Q: If I outsource my laser marking, do I still have to be responsible for certification?

Even in the case of OEM, the FDA still sees the brand owner as the primary responsible party.Make sure that the contract requires the factory to provide quality assurance documents, and that they regularly review their quality control records.Last year, one company was fined US $ 2 million by the FDA after a contract manufacturer changed the gas in a laser used in the production process, resulting in the loss of a product label.