US FDA Medical Device Registration Process Overview| US FDA Regulatory Pathway & Classification

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US FDA Medical Device Registeration Process Overview| US FDA Regulatory Pathway & Classification @ivdmanufacturing7208

Medical devices are classified into Class I, II, and III. Regulatory control increases from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval. A description of device classification and a link to the Product Classification Database is available at "Classification of Medical Devices."

The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are:

Establishment registration,
Medical Device Listing,
Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA),
Investigational Device Exemption (IDE) for clinical studies
Quality System (QS) regulation,
Labeling requirements, and
Medical Device Reporting (MDRHow to Register Your Device with the USFDA?
Establishment Registeration
Device Listing
510K
PMA
Pre Market Notification
Classify Your Medical


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