Here another example:
No More 510(k)-only PMA required for all Automated External Defibrillators (AEDs)
FDA has finalized a change in policy that will soon require all Automated External Defibrillators (AEDs) to undergo a more rigorous regulatory review process meant to ensure the devices—which have failed in tens of thousands of reported cases since 2005—function reliably when they are needed most.
The reason for the change, FDA explained in a press statement, was that regulators have become aware of “approximately 72,000 medical device reports associated with the failure of these devices.”
“Since 2005, manufacturers have conducted 111 recalls, affecting more than two million AEDs,” FDA noted. “The problems associated with many of these recalls and reports included design and manufacturing issues, such as inadequate control of components purchased from other suppliers.
FDA said it will not take action against any AED or AED accessory already on the market until 29 January 2020, when it expects all marketed AEDs to be covered by an approved PMA. New devices, however, will be required to be covered under the PMA process much sooner.

Reference: http://www.raps.org/Regulatory-Focus/News/2015/02/02/21225/High-Failure-Rate-for-AEDs-Prompts-FDA-Change-in-Regulatory-Policy/
Here also another example:
https://www.markey.senate.gov/imo/media/doc/2013-01-10_FDA_RE_Sound.pdf