Designed to assist laser manufacturers and integrators with CDRH and FDA compliance reporting requirements for the sale of lasers in the USA.
CDRH Product Certification Audit
The Center for Devices and Radiological Health (CDRH) is a division of the Food and Drug Administration (FDA) and requires that all products containing lasers that are imported or sold in the United States must be certified. U.S. laser manufacturers must report their products to the CDRH for a type of prior approval. These laser product reports are typically 35 to 60 pages in length and require specialized analysis and data. Manufacturers and importers of lasers must also file additional special reports once a year. Kentek’s Product Certification Auditing services are designed to assist laser manufacturers and integrators in becoming compliant with the CDRH and FDA reporting requirements to help avoid penalties and fines with the sale of lasers in the United States of America.
- Review all Engineering Controls required by CDRH 21CFR1040
- Protective Housing
- Key Control
- Emission Indicator
- Manual Reset
- Perform hazard analysis for each laser
- Assist with CDRH report writing
Kentek will perform a complete hazard analysis on the laser and make recommendations on engineering controls and design. Kentek will also assist with preparing the forms needing submittal to CDRH and guide the customer in the submittal process. Pricing for this service will fluctuate depending on the number of lasers, days to perform the audit, estimated time assisting with CDRH forms, location and travel costs.
Laser Classification Validation
Kentek can assist and support your organization in the laser classification validation of a laser system/enclosure according to CDRH and ANSI Z136.1 “Safe Use of Lasers” standard during periods of normal operation, maintenance and service. We will provide a Laser Hazard Analysis Report for each system, recommendations for Engineering Control Compliance to achieve Class 1 (if necessary), and Administrative and Procedural Control recommendations (if necessary).
Call 800-432-2323 for a price quote. Ask to speak with one of our Laser Safety Services Specialists.