Biomedical Engineering Reference
In-Depth Information
7.2.2 Medical device approval process - the Food and
Drug Administration
The routes to marketing a medical device product in the United States are a 510(k)
Premarket Notification, Premarket Approval (PMA) or Product Development
Protocol (PDP). Combination products that are a combination of more than one
type of product such as a drug/device, biologic/device, drug/biologic will be
reviewed later in this chapter as these products are regulated according to the
primary mode of action, but also may be subject to more than one type of review
process and regulations.
Food and Drug Administration premarket notification
The premarket notification 510(k) process requires a medical device manufacturer
to 'notify' FDA 90 days before they propose to begin marketing a new or certain
modified device. This notification submission allows FDA to determine whether a
device is substantially equivalent to one or more predicate devices.
By law, a device is substantially equivalent (SE) to another legally marketed
device if it has the same intended use and either the same technological character-
istics or different technological characteristics but is as safe and effective as the
other device and does not raise different questions of safety or effectiveness FDCA
513(I)(1)(A)g.
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The goal of a 510(k) Premarket Notification submission is to
demonstrate substantial equivalence to a device that is already legally marketed.
The name comes from section 510(k) of the Food Drug and Cosmetic Act
(FDCA).
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The 510(k) process involves a comparison of one device to another
legally marketed device. The device used for comparison purposes is referred to as
the 'predicate' device. The FDA recommends a format for submitting 510(k)
Premarket Notifications which is outlined in the guidance document
Format for
Traditional and Abbreviated 510(k)s
.
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Elements of a premarket notification 510K submission
Information to be submitted in a 510(k) premarket notification to FDA includes:
•
submitter's name, address, contact person, authorized agent in the USA if the
submitter is outside the USA
•
name of device
-
classification name
-
common name
-
proprietary name (brand name)
•
FDA establishment registration number and address
•
classification of device/classification panel
•
performance standards
