Abstract:
:The author reviews the regulatory process through which new cardiovascular interventional devices reach the hands of the interventional radiologist and the cardiologist. The marketing mechanisms are outlined, as are the data requirements. The reader is taken step-by-step from device investigation conducted under an approved investigational device exemptions application to market clearance, through either a substantially equivalent 510(k) notification or an approved premarket approval application, and beyond, including how to report adverse device experiences through the Medical Device Reporting REgulation and the Medical Device and Laboratory Product Problem Reporting Program.
journal_name
Radiologyjournal_title
Radiologyauthors
Reamer LAdoi
10.1148/radiology.174.3.174-3-923subject
Has Abstractpub_date
1990-03-01 00:00:00pages
923-5issue
3 Pt 2eissn
0033-8419issn
1527-1315journal_volume
174pub_type
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