Rockwell Laser Industries
Laser Safety Products, Training and Consulting at Rockwell Laser Industries
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CDRH Consulting Services

CDRH Consulting Services

CDRH Consulting Services

We help laser product manufacturers to complete required laser and laser product initial reports as mandated by the Federal Laser Product Performance Standard (21 CFR Parts 1040.10 and 1040.11).

For more information regarding CDRH consulting services, please contact us via email or call a consulting representative at (800) 94-LASER.

 

Federal Standard Compliance Reports

Rockwell Laser Industries offers a complete assistance package for manufacturers of laser products in completing the required laser and laser product initial reports as mandated by the Federal Laser Product Performance Standard (21 CFR Parts 1040.10 and 1040.11).RLI will review with the client all aspects required for classification and certification relative to the FDA/CDRH requirements. This includes items such as:

  • Human access: limitations, definition and requirements
  • Classification: AEL determination based on normal operation
  • Operation, maintenance, and service: distinctions and safety requirements for each
  • Performance features: interlocks, protective housing, remote interlock connector, key control, emission indicator, beam attenuator, controls, scanning safe guards, manual reset...etc.
  • Product labeling: logotype, protective housing, aperture, identification, certification
  • Documentation requirements: cautionary statements and other requirements
  • Quality control: requirements
  • Beam measurement: requirements and instrumentation

Below are a few of the CDRH compliance consulting services offered by Rockwell Laser Industries (RLI). RLI is prepared to customize any of the services described specifically to the needs of a client.

A comprehensive summary of the audit's findings is reviewed by the RLI staff following the on-site audit. Then a comprehensive audit summary report is provided to the client which includes specific recommendations.

RLI Generated CDRH Report

RLI can generate the FDA/CDRH Laser Product Report ready for client signature and dating. The number of days required depend on the degree of complexity of the product being reported. Most products of the machine tool variety require three to four days. In a few instances as many as five days and as few as two days have been required.

Initial Client Meeting

When assisting a client with FDA/CDRH laser product certification, RLI meets at the outset to establish the nature of the product and determine potential classification category. The initial meeting usually occurs at the client's facility where a detailed examination of the product can be done. During this visit RLI will consult concerning equipment modification that may be necessary to meet the CDRH requirements and prepare a list of documentation items that will be needed from the client in order for RLI to generate a report. Following this meeting, immediate work can begin on gathering the information still lacking. Once gathered, a draft report is generated and reviewed with the client. After the review, a final report is prepared for the client's signature and submission to FDA/CDRH. Additionally, RLI will provide a draft of an appropriate cover letter addressed to the FDA/CDRH to accompany the report submission.

It is important to stress that this report will be based on the information supplied by the client concerning the design and application of the laser product. Specifically, the client will be responsible for providing in a timely fashion all documents, drawings, photos, applicable component specifications and other information deemed necessary by RLI to provide as part of the content of the initial report.

Report Submission and Certification

When the CDRH report is submitted, the laser product is then "technically" certified since this process is a manufacturers "self-certification". The client should receive a letter from the CDRH in about six weeks which will indicate they have received the report and have filed it under an accession number (the CDRH file designation for the product). The accession number must be kept and used for any future correspondence relative to the product. Several months later, after FDA/CDRH staff members have had an opportunity to read and evaluate the report, the client will receive either a letter stating they have no further questions, or a letter requesting additional information. Eventually the client will receive a letter indicating that they have no further questions.

RLI will prepare requests for any exemption or variances that seem applicable and appropriate for the product under consideration.

Long-Term RLI Support

RLI will assist the client in response to any questions and/or concerns that CDRH may express regarding their review of the initial report. This support will be at no additional consulting fee provided the inquiry is based upon the data and information which had been made available to RLI at the time of submission. However, if travel should be required, the client will be responsible for actual travel expenses.

Review of Client Generated CDRH Report

A client may prefer to generate a FDA/CDRH Laser Product Report on their own, and have RLI preview the report for completeness proper to submission of the report to FDA/CDRH. RLI will report to the client all areas of deficiency of the report, and recommend appropriate additions or modification. This may, or may not, be in conjunction with any on-site audit of the product.

For more information regarding CDRH Consulting Services, please contact us via email or call a consulting representative at (800) 94-LASER.