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CDRH Laser Classification & Penalties for Non-Compliance


If a product is developed under a compliance plan -- such as those produced by Laser Compliance® -- generally there are no problems with the U.S. CDRH regulatory agency. However, if a product is not developed with CDRH compliance in mind, there are a number of problem areas that are typically found. In these cases, products would bring citations immediately upon inspection. A Corrective Action program must be developed and implemented.


Typical areas of non-compliance


Products not registered with CDRH (lack of IPR) 1002.11.

Products may not be legally certified by manufacturer 1010.2.

No quality assurance testing program in place.

Non-compliant user information 1040.10h.

Maintenance and service information.

No manufacturer’s testing and certification records 1002.30.

Brochures and/or web pages do not display Class Warning type logo. (non-compliant warning logotype) 1040.10h.

No Annual Reporting 1002.30.

Inadequate or Improper labeling.

None or improper dealer record keeping.



Correcting Non-Compliance


The CDRH periodically inspects laser products and manufacturers. In an inspection of a company that has not addressed CDRH compliance, the CDRH typically finds problems with a dozen or more requirements.

When inspected and found to be not in compliance, manufacturers are required to generate a Corrective Action program and submit it to the CDRH for approval. 1004.1.

A Corrective Action program would likely require all of the compliance items outlined above as part of product certification as well as additional work.

Laser Compliance® can develop Corrective Action programs for companies who have been ordered to fix their violations. Invariably, the Corrective Action program costs several times more to complete than it does to complete the process correctly in the first place. This is why we stress compliance before the product is entered into commerce.


Product Liability Exposure


Another very important issue to consider when it comes to CDRH Compliance. Products that do not comply with safety regulations, have the ability to be quite damaging in court.

In liability lawsuits, lawyers can exploit the fact that the product was not in compliance with federal regulations and safety requirements. They can argue to the jury that this indicates a company was acting recklessly without regard for safety and legal concerns.



For Additional Information


See the Frequently Asked Questions section about penalties for non-compliance




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