Service at a glance
| Item | Details |
|---|---|
| Provider | Hopkins MedTech Compliance |
| For | Medical device and IVD establishments |
| Work | FDA establishment registration and device listing |
| Rules and standards | FDA registration and listing requirements |
Our services include assistance with Establishment registration and device listing, Any establishment involved in the production, importation, reprocessing/relabeling, or developing specifications of a medical device or in vitro diagnostics (IVD) for commercial sale in the United States must register annually with the US Food and Drug Administration (FDA). This is called "Establishment Registration" and it is a separate process from obtaining 510(k) clearance or PMA approval.
Service information adapted from the original source ↗.
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