Post-Approval Studies (PAS)The CEO mentioned the possibility of an Observational Study. Can anyone figure out the
difference between this and a Post-Approval Study?
"The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) approved medical devices."
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma_pas.cfm