Typical areas of CDRH non-compliance
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Products not registered with CDRH (lack of IPR) 1002.11. |
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Products may not be legally certified by manufacturer 1010.2. |
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No quality assurance testing program in place. |
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Non-compliant user information 1040.10h. |
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Maintenance and service information. |
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No manufacturer’s testing and certification records 1002.30. |
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Brochures and/or web pages do not display Class Warning type logo. (non-compliant warning logotype) 1040.10h. |
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No Annual Reporting 1002.30. |
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Inadequate or Improper labeling. |
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None or improper dealer record keeping. |
Correcting CDRH Non-Compliance with Corrective Action Plans
The CDRH periodically inspects laser products and manufacturers. In an inspection of a company that has not addressed CDRH laser compliance, the CDRH typically finds problems with a dozen or more requirements.
When inspected and found to be noncompliant, manufacturers are required to generate a Corrective Action program and submit it to the CDRH for approval. 1004.1.
A Corrective Action Plan would likely require all of the compliance items outlined above as part of product certification as well as additional work.
Laser Compliance® develops Corrective Action plans for companies who have been ordered to fix their violations. Invariably, the laser product compliance 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 and to contact us with our compliance guide for lasers.
Product Liability Exposure
Another very important issue to consider when it comes to CDRH Laser Noncompliance is that 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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