Federal regulators today issued 2 final rules formalizing the FDA review process for new and existing implantable pacemakers and pacemaker programmers.
The rules require pre-market approval or completion of a product development protocol for all pacemakers and programmers that were in commercial distribution before 1976 as well as those originally cleared for the U.S. market by demonstrating that they were equivalent to an earlier device.
Device makers now have 90 days to filed a PMA or PDP or else cease distribution of such devices, according to a notice in the Federal Register.
The rules aren’t expected to make many waves with medical device companies, as modern pacemakers and programmers don’t rely on earlier devices to demonstrate safety and efficacy, the FDA noted.
"There have been no 510(k) submissions for implantable pacemaker pulse generators since 1999, with the exception of 1 510(k) submission cleared in 2001 that was erroneously coded as an implantable pacemaker pulse generator (product code DXY), but is actually for an external pacemaker," according to the report. "Current pacemakers have newer features and capabilities that have rendered them not substantially equivalent to the devices cleared under 510(k) prior to 1999, which are obsolete."
The FDA issued the proposed rule in July 2011 and asked for comments and suggestions from the public.
"FDA received 1 comment on the proposed rule for the implanted pacemaker pulse generator," according to the rule. "The comment was a general statement supporting the requirements for filing of a PMA for this device."
The same was true for the rule proposing a formalized PMA pathway for pacemaker programmers, which was initially issued in August 2011, according to a separate report.
