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".