I was going to write a long post on this, but I sense that you're coming from a background of different premises. May I simply suggest that the FDA often cries

I was going to write a long post on this, but I sense that you're coming from a background of different premises. May I simply suggest that the FDA often cries wolf, and vastly exaggerates threat levels associated with things outside their supervision? I will cite two examples and leave it at that for now. 1) Here is the FDA's 2009 testimony on drugs imported from Canada. Note how they endorse a denunciation of imports in the harshest terms, stating that Canadian imports of "unapproved drugs" are a "violation" that "put Americans at serious risk". http://www.fda.gov/NewsEvents/Testimony/ucm114735.htm On November 6, 2003, Federal District Court Judge Claire V. Eagan, U.S. District Court for the Northern District of Oklahoma, issued a decision in United States v. RX Depot, Inc. and RX of Canada LLC, granting a preliminary injunction to immediately prevent these defendants who operate business that import prescription drugs from Canada, because such unapproved drugs were a clear violation of the FD&C Act. In addition to her unequivocal findings of law, the Judge concluded that these companies could not assure the safety of the drugs they have been importing and, as a result, in violating the law have put Americans at serious risk. These are Canadian pharmacies we're talking about. It's not exactly Somalia up there. 2) Here is a sample FDA warning letter to UltraRad from May 2009. All of these letters always start out like a horror story: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm173977.htm This inspection revealed that this device is adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, its manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. No written response was received from you concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations that was issued to William J. Giunta, Vice President of Service, on March 5, 2009. These violations include, but are not limited to, the following... Wow, "adulterated", that sounds awful! What were these terrible violations? Let's read further down: 4. Failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system as required by 21 CFR § 820.70(i). This was a repeat violation from a previous FDA-483 that was issued to your firm. For example: A) Your firm uses off-the-shelf software (HEAT Help Desk) to manage customer support service calls and to maintain customer site configuration information; however, your firm failed to adequately validate this software in order to ensure that it will perform as intended in its chosen application. Specifically. your firm's validation did not ensure that the details screen was functioning properly as intended. The details screen is used to capture complaint details and complaint follow-up information which would include corrective and preventative actions performed by your firm when service calls are determined to be CAPA issues. B) Off-the-shelf software (Microsoft SharePoint) is being used by your firm to manage your quality system documents for document control and approval. However, your firm has failed to adequately validate this software to ensure that it meets your needs and intended uses. Specifically. at the time of this inspection there were two different versions of your CAPA & Customer Complaint procedure, SOP- 200-104; however, no revision history was provided on the SharePoint document history. Your firm has failed to validate the SharePoint software to meet your needs for maintaining document control and versioning. I cite this particular example solely because you as a software engineer have the expertise to see how ludicrous this citation is. They are literally saying that a small business needs to do "software validation" of a multibillion dollar product like Microsoft Sharepoint to "ensure that it meets [their] needs and intended uses". This was the grounds for claiming that UltraRad's product was "adulterated", trashing their reputation on the internet and exposing them to fines and penalties. So: all I ask is that you read through a sample of FDA warning letters sometime with a more skeptical eye, keeping in mind that their form of writing is highly optimized for surface optics. Focus on the claimed software violations and try to translate them into plain English and you will see there is often not much there. This may shift the needle on your premises about whether the FDA is credible when it cries "catastrophe unless we regulate".