US Food and Drug Administration (FDA)

Implement a gap analysis for 505(b)(2) applications to identify safety data needs and adjust safety monitoring systems as necessary to accommodate new product characteristics.

Review the guidance to ensure compliance with post-marketing safety reporting timelines and annual report submissions; update SOPs for ICSR processing and periodic report generation.

Identify which unclassified medical devices are affected by the exemption; update regulatory submissions and post-market surveillance plans accordingly; ensure compliance with general controls and post-market surveillance obligations.