Professional Medical Education Association, Inc.
The Laser Training Institute™
FDA RULES FOR MEDICAL APPLICATIONS OF LASERS:
The FDA does NOT regulate physicians or nurses in the practice of medicine or the use of any laser product. They regulate the companies that manufacture and sell the medical laser products. A company must be approved by the FDA to market their device, and these companies are allowed to promote the medical use of their laser products ONLY for the specifically approved applications. This does NOT mean that physicians are limited to only these approved applications. It simply means that the company cannot promote a use if it is not officially approved for such by the FDA. If it is approved for ANY use at all, an institution may purchase the equipment and make their own decisions about how to use it. This is a common and legitimate practice with laser use and, even though there are no further regulatory constraints in using a laser in any way you want, the "reasonable man standard" would dictate that physicians wanting to use lasers for non-approved uses simply submit a credible proposal to their own institutional review board (IRB) for review and approval. Third party payers vary in their policies about whether or not they'll reimburse for "non-approved" applications, and this should be discussed with the patient and insurer beforehand.
FDA RULES FOR TECHNICAL INFORMATION AND SERVICE:
Listed below is a brief summary of FDA rules for laser manufacturer's and dealers in supplying technical service manuals for all users, plus a link to the FDA site with the complete Code of Federal Regulations. The FDA contact for enforcement of these standards is also included.
FDA Technical & Service Requirements:
Power Calibration: The power output, and internal power meter of your laser is required to be calibrated periodically (no definite date given now, but recommended by companies annually). This must be done using an external power meter which has been referenced to a national standard. (More information on power meters and suppliers is provided in our Laser Maintenance class). Your laser's internal meter must indicate plus or minus 20% of the actual delivered power at the output of the delivery device. This 20% variance applies to both the high and low ends of the power output. The user must check the power output of their laser in every case (using only the laser's meter - not an external one).
Service Manuals: Laser Manufacturers are REQUIRED by the FDA, through the Code of Federal Regulations, to provide service manuals to servicing dealers and distributors, "and others" UPON REQUEST. It must be made available at a cost not to exceed the reasonable cost of preparation, and must have adequate instructions for service adjustments and service procedures for each laser product model . . . . Part of the original reasoning for this requirement is that if the company goes out of business at some point, that users may still maintain their equipment. These requirements are found in 21CFR 1040.10 H2II. (Informational Requirements - Purchasing and Servicing Information) For type III and IV lasers (virtually all medical lasers) they must supply the SPECIFIC calibration procedures for the laser as found in 21CFR 1040.11 A2. These hyperlinks will take you to the actual CFR's, or click on the FDA links below to see the overall index and general FDA pages. You should review your service manual upon delivery to ensure that it is COMPLETE with required alignment and calibration procedures. There is NO REQUIREMENT that you have attended any of that company's service training, or in any other way be "authorized" by the company in order to obtain the complete service manual. You or your hospital simply have to own the laser - in fact the regulation is worded "and others", so that anyone may request a service manual. Failure of the company to comply with this requirement could potentially result in the FDA shutting them down.
IF you have problems obtaining complete service manuals.. Should you have a problem in obtaining such service information from the manufacturer, call the FDA enforcement officer and obtain the name and telephone number of that company's REGULATORY AFFAIRS person. Call that person at the company and politely explain to them the problems you are having, and that you are aware of the CFR requirements to supply such information. They will usually resolve the problem for you quickly. If you continue to have problems, or continue to receive incomplete information, you should call the FDA enforcement officer to initiate compliance. If you've had any problems with laser companies not supplying such service manuals or parts, we'd appreciate it if you'd also let us know so that we can keep hospitals and users advised of potential problems.
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FDA Contacts and Links:
Contact for Enforcement and info on Regulatory Affairs contacts: (NOTE - many of the phone numbers have since changed with FDA re-organization. Just call the main FDA number and ask for the specific dept.)
U.S. Food & Drug Administration
Center for Devices and Radiological Health
Office of Device Evaluation
10903 New Hampshire Avenue
Sliver Spring, MD 20993
Office of the Director
(You may have to ask for the compliance officer if you call)
CDRH main page within the FDA - dealing with medical laser product requirements.
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Index to Code of Federal Regulations (CFRs) - This link takes you to the overall index. If you want to go to the specific sections on the service manuals, click on those links in the service manual section listed above instead of here, or write the numbers down and find them in the index:. This will leave our site and go directly to the FDA, don't forget to mark your browser to return