Devices operating below 490 kHz and 40 dB below the part 15 limit are exempt from certification (i.e. FCC submission), but not from verification (i.e. measurement).
Why did Medtronic operate their devices illegally for so many years? Could it have been because low-frequency inductive communications allow you to communicate with an implant right through the metal wall of the implant? For inductive communications you don't need to put an "RF hole" in the can which would allow high-level RF energy to enter the implant. This allows you to provide significant protection to an implant from external sources of RF. Concerto added an RF hole into their implant which allows a broad spectrum of RF energy right into the implant with significant coupling onto the therapy circuits. Is this a problem? Check out my post on MRI safety which will appear in the evening on February 15th.
So many proverbs, so little space, but in my opinion "power corrupts" fits best in this case. If I saw a baby on a train track, I would ignore the "No Trespassing" sign in order to save the baby. In that regard, I agree with bending the rules for life critical applications, but only temporarily until a correction can be made or the rules changed. Medtronic could have become legal years ago, but because of the need for the therapy I believe regulators cut Medtronic slack. It made sense at the time, but by allowing Medtronic to get away with breaking rules everyone else has to follow for many years they didn't do Medtronic or their patients any favors. Medtronic's mentality of rule breaking has now spread from strictly issues of legality into areas of patient safety. By knowingly cutting corners in order to catch up to the competition Medtronic is taking risks that a high-reliability cell phone manufacturer would not take. I pray that the gamble pays off for them, but if I needed an implant, a distance telemetry device would be my last choice.