In the USA laser safety is dealt with by regulations which are part of federal law as opposed to Europe where manufacturers self-certify to various product standards. CDRH, which is part of the FDA (Food and Drugs Administration), has the task of enforcing the regulations. The laser product regulation is known as 21 CFR 1040.10.

The Center for Devices and Radiological Health (CDRH) is the agency responsible for ensuring the safety and effectiveness of medical devices and regulating radiation-emitting electronic products, both medical and non-medical. 

To legally enter the USA a laser product (or systems incorportating lasers) must have an accession number which needs to be quoted on the importers declaration. To obtain the accession number a laser product report must be submitted to the FDA. This is the duty of the laser manufacturer.

Any representative from the manufacturer can submit the laser product report. However, compilation of the report is extremely laborious, time consuming and confusing for those who are not informed of the requirements. In addition, unless you are familiar with the regulation it is quite likely that the report will contain inaccuracies which may cause a problem with the FDA.

In order to save you time and effort Lasermet offer FDA submission services to compile and submit the report on your behalf.

Broadly there are three main types of submissions to the FDA / CDRH.

Laser Notice 56 and European Manufacturers

In 2019 the FDA issued Laser Notice 56. This states that the FDA will accept classification and labelling to IEC 60825-1 as opposed to the classification and labelling detailed in 21 CFR 1040.10 which differs significantly.

IEC 60825-1 is the international standard dealing with the optical safety of laser products and is identical to EN 60825-1. This enables manufacturers to use one classification and one set of labelling for their laser products, instead of two. Consequently, for non-US manufacturers, we normally register laser products under 21 CFR 1040.10 in conjunction with Laser Notice 56, unless there is a specific reason for not doing so.

Laser Product Reports

Completing a laser product report requires a huge amount of information from the manufacturer. Occasionally, it is discovered that there are errors with the laser product or with the documentation – the most common example of this is its user manual does not contain all the information requirements of BS EN 60825-1:2014. Sometimes, it has been found that the interlocks used are not adequate or the labelling is wrong. If this is the case, it is essential that the errors are amended before the laser product report is submitted and the laser imported.

REQUIRED DOCUMENTS FOR FDA PRODUCT REPORTS

• Manufacturers name and address
• Prime contact at the manufacturer
• Letter of acceptance by the importing agent
• List of all names and model numbers for the product
• Description of the laser product
• Intended Class of product
• Class of any embedded lasers (if applicable)
• Manufacturer’s data on the laser source
• Wavelengths accessible during normal operation
• Approximate powers accessible during normal operation
• Circuit diagrams relating to laser power (if below Class 4)
• Details of structure of the product including information on optical path
• Details of pulse structure
• Any additional equipment necessary to operate unit
• Copies of all required laser safety labels
• Copies of user and service manuals
• Copies of catalogues, specification sheets, and brochures
• Interlock datasheets and logic diagram (if applicable)
• Quality Control documentation
• Classification report

Supplement Reports

A supplement report is used to make an update or report any changes to an existing accession number.

Cases where a supplement is required include:

• a new laser product is being added to an existing family already registered
• a laser product which has already been registered is being modified
• a laser manufacturer has changed business name, address, etc.

Supplement reports will be required for changes that affect actual or potential radiation emission, or affect compliance with a standard or manner of testing for radiation safety.

It is necessary to provide the accession number being updated, and details of how the new product differs from those already registered, or how the existing product has been modified. Any evidence which supports the design changes — for example, the new product’s user manual or the datasheet for the new laser source being used — must be submitted along with the supplement report.

Annual Reports

Every year by 31^st August, laser manufacturers are required to submit Annual Reports to the FDA giving information on the laser products they have sold into the USA for the preceding period (July 1 to June 30).

Annual reports summarise the contents of the records required to be maintained and providing the volume of products produced, sold, or installed.

Worldwide Service

While carrying out this service, communication between our consultants and the customer is carried out primarily by email with some telephone contact if necessary. There is no need to send in a sample product to complete FDA submissions. Consequently we are able to carry out this service for manufacturers throughout the world without being hindered by distance.