Laser Compliance provides thorough CDRH compliance and CDRH certification consulting services to laser product manufactures. Our CDRH consulting services include:
 Evaluations of if you are considered a ‘manufacturer’ from the perspective of the CDRH
Product importation guidance
Identification of relative needs and concerns against the FDA’s CDRH laser product standards
Provide education about relative CDRH compliance requirements
Product engineered safety features evaluation against the CDRH laser product standards
Product emissions evaluation against the CDRH laser product standards
Provide guidance of potential product alterations or modifications to comply with CDRH standards
Documentation templates and drafts for CDRH submissions
FDA Laser Regulations
The FDA’s Center for Devices and Radiological Health (CDRH) regulates the manufacturing of electronic products that emit radiation, including products with lasers. FDA laser regulations recognize four major classes for lasers, and all require CDRH registration or reporting to be compliant with federal law. Without CDRH compliance and registration, no laser product can legally enter the US, and it cannot be used, sold, or distributed in American markets. The purpose of these regulations is to ensure that all laser products do not expose the public to hazardous or unnecessary radiation, and failure to comply with these regulations, and obtain register or report with the CDRH registration can result in severe penalties.
To legally enter the US, a laser product needs an accession number that will be quoted on the “importers declaration.” A OEM registration or laser product report must be submitted to the FDA for this number to be obtained. The laser product report must include detailed information, which can be very tedious and time-consuming to draft. If you do not know the regulations for CDRH compliance and how they apply to your product, there will likely be inaccuracies in the report that could cause a problem with the FDA and increase the time it takes to obtain an accession number. This makes is a good example of why it important to work with expert CDRH consultants at Laser Compliance. Call us today to speak with a professional consultant.
CDRH Consulting Services for Lasers
Laser Compliance has the experience and expertise necessary to ensure your laser product aligns with CDRH requirements so it can be distributed and sold legally. As expert laser consultants, we’ll work alongside you throughout every step in the process, by helping you from the design process to product testing, submitting the correct documents, and interpreting all relevant legal and industry-specific regulations.
No matter how niche of an industry your product is intended, or how specific the use is, our specialized team of CDRH laser product consultants will know exactly what it takes to make your product compliant with FDA laser regulations.
Considering the potential severe setbacks and penalties, you want to ensure your product is compliant with all CDRH regulations from the start. Contact Laser Compliance CDRH compliance consultants today to make sure no step is missed and save valuable time and resources in your product’s CDRH compliance and certification process.
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