Laser products that will be marketed in the United States of America must be registered with the CDRH (Center for Devices and Radiological Health), a department belonging to the FDA (U.S. Food and Drug Administration).
From ProCareLight we can take care of the entire technical-administrative process, from preparing the documentation and submitting it to the CDRH to obtaining the accession number corresponding to the registration of your laser product and also the annual maintenance of the registration.
It is necessary to have all the information and tests related to the safety of the laser product, all obtained through a technical examination.
The laser product must meet the standards of the Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) parts 1000-1005 and 1010-1040.
LASER PRODUCT REPORT
The Laser Product Report must be prepared, in accordance with the requirements of the CDRH, and the documentation that certifies compliance with all regulatory requirements must be attached.
It is a complex task that requires some familiarity with the FDA's methods.
ACCESSION NUMBER REQUEST
Few days after submitting the Product Report, the CDRH will award an accession number to the laser product.
From this moment on, the laser product can be sold in the United States of America.
MAINTENANCE OF THE REGISTRATION
In some cases it will be necessary to submit an annual report to maintain the validity of the accession number.
ProCareLight can take care of gathering the necessary information, preparing the Annual Report and presenting it in accordance with the requirements of the CDRH.