Special Controls Set By FDA For External Pacers, Analyzers
This article was originally published in The Gray Sheet
Executive Summary
A final order from the agency places external pacemaker pulse generators in class II, and also puts pacing system analyzers into a separate class II category – including triple-chamber analyzers, which was previously been regulated as class III PMA devices. All new language or significantly modified products in the categories will be subject to 510(k)s.
You may also be interested in...
US FDA Electromagnetic Compatibility Guidance Finalized
In the final medical device electromagnetic compatibility guidance FDA clarified the scope of applications that could use this guidance and added a recommendation for sponsors to identify and consider the intended use environmental that could affect the EMC of their products.
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.
GLP-1 Coverage Restrictions In Medicare Part D Surge As Demand For Obesity Drugs Grows
A major shift from unfettered coverage to prior authorizations was recorded by MMIT over the past year for the leading GLP-1/GIP agonist diabetes drugs. Public interest in using the drugs off label for weight loss drove the change.