As someone who works with software that is audited by the FDA (we build devices to collect data for clinical drug trials), I'm assuming the regulatory agency kn

As someone who works with software that is audited by the FDA (we build devices to collect data for clinical drug trials), I'm assuming the regulatory agency knew about this issue before the equipment was certified for use. Any bugs that we defer from a product release are documented, and therefore reviewed by anyone that decides to audit the company. We are routinely asked by auditors to explain why certain bugs were deferred prior to release.