U.S. FDA
Pre-market Submission (510k)
The FDA regulates food, drugs, medical devices, biologics, cosmetics and radiation emitting products in the USA. FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating manufacturers of medical devices.
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.
Class 1
Low to moderate risk
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Classification
Class I exempt
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Controls
General Controls
General Controls are the basic authorities of the Medical Device Amendments that provide the FDA with the means of regulating devices to ensure their safety and effectiveness
Class 2
Moderate to high risk
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Classification
Premarket Submission (510k)
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Controls
General / Special Controls
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Patient registries
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Special labeling requirements
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Premarket data requirements
Class 3
High risk
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Classification
Premarket Approval (PMA)
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Controls
General Controls, Premarket Approval
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Administrative, limited scientific review, substantive review, panel review, final deliberations, documentation, and notification of the FDA decision
Basic regulatory requirements
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Labeling requirements
Labeling includes labels on the device as well as descriptive and informational literature that accompanies the device.
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Premarket Notification 510(k)
If your device requires the submission of a Premarket Notification 510(k), you cannot commercially distribute the device until you receive a letter of substantial equivalence from FDA authorizing you to do so.
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Unique Device Identification System (UDI)
The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use. When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form, which will ultimately improve patient safety, modernize device postmarket surveillance, and facilitate medical device innovation.
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Medical Device Reporting (MDR)
Incidents in which a device may have caused or contributed to a death or serious injury must to be reported to FDA under the Medical Device Reporting program.
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Quality System (QS) regulation
The quality system regulation includes requirements related to the methods used in and the facilities and controls used for: designing, purchasing, manufacturing, packaging, labeling, storing, installing and servicing of medical devices. Manufacturing facilities undergo FDA inspections to assure compliance with the QS requirements.
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Premarket Approval (PMA)
Product requiring PMAs are Class III devices are high risk devices that pose a significant risk of illness or injury, or devices found not substantially equivalent to Class I and II predicate through the 510(k) process. The PMA process is more involved and includes the submission of clinical data to support claims made for the device.