Hi Jeffrey, I've seen answers to this post regarding enforcement of the IEC standard, as well as to the CDRH rules. However, no one has mentioned FDA audits.
The FDA does conduct periodic audits at the manufacturer's location as reported in the Product Reports and Annual Reports submitted to them. The auditor will check record keeping, quality control, and product design aspects such as proper labeling. My company has been producing laser products for many years, and only one audit has been conducted, that anyone can remember. I was the representative during that audit, and I commend the auditor on his professionalism and thoroughness. The auditor was a pleasure to work with, but he was very thorough. Rather than a 'let me see what I can nail you on' attitude, the auditor I dealt with had a 'let me see if I can help you improve your compliance process' attitude. The auditor will call ahead and let you know the date for the audit - an appreciated courtesy, but the date is not negotiable. Note that the FDA only has jurisdiction over manufacturing locations within the US. That's why it falls largely to customs to enforce imported goods, I presume. It is also noteworthy that the FDA has a very broad scope and generally has much bigger fish to fry than a manufacturer of low-power laser devices - I think that's why the frequency of audits for manufacturers like us is so low. You may never have the pleasure. For complete information about penalties and other administrative topics, check http://www.fda.gov/cdrh/radhlth/fdcact5c.html , the Electronic Product Radiation Control section of the Federal Food, Drug, and Cosmetic Act. Section 360pp covers Enforcement and Penalties. Hope this helps.
