Subject: Allegations of Regulatory Misconduct Website and 12CFR
I commend the FDA in the launch of this website and new program and form. There should be a simple way to report alleged problems.
But how is the FDA going to take action on reported problems? There are already many rules and laws on the books that the FDA is supposed to be enforcing that go unenforced. The major ones that I am referring to are the AIAT (Assemble-Install-Adjust-Test) rules contained in 21CFR 820. 21CFR requires equipment manufacturers to provide adequate documentation to anyone who requests it. This information is necessary to be able to provide a basic level of AIAT and device safety for radiation-producing devices.
The FDA has habitually ignored and refused to enforce these laws for many, many years. I have no confidence that you will be ready, willing or able to do any better with this new initiative than previous ones.
If you, or anyone else from the FDA would like to discuss this in more detail, I am willing to assist and help craft a solution that provides maximum safety for the patients of the United States Healthcare system. But don’t call until next week – I will be at the FDA conference in Silver Spring, Maryland on Thursday and Friday attending the Refurbishers and Repairers hearing, hoping to convince the FDA that there are no safety issues related third party or end-user repairers of medical devices.