Recent Device Approvals
Welcome to FDA's information about medical device approvals. The following
information is available:
Information for manufacturers who want to market a device intended for
human use can be found in Device
Advice.
Databases
CDRH maintains searchable databases on its website containing 510(k)
and PMA information
A 510(k) is a premarketing submission made to FDA to demonstrate that
the device to be marketed is as safe and effective, that is, substantially
equivalent (SE), to a legally marketed device that is not subject to premarket
approval (PMA). 510(k) (premarket notification) to FDA is required at
least 90 days before marketing unless the device is exempt from 510(k)
requirements.
Premarket Approval (PMA) is the most stringent type of device marketing
application required by FDA. A PMA is an application submitted to FDA
to request approval to market. Unlike premarket notification, PMA approval
is to be based on a determination by FDA that the PMA contains sufficient
valid scientific evidence that provides reasonable assurance that the
device is safe and effective for its intended use or uses.
Regulation also provides for the submission of a humanitarian device
exemption (HDE) application. A Humanitarian Use Device (HUD) is a device
that is intended to benefit patients by treating or diagnosing a disease
or condition that affects fewer than 4,000 individuals in the United States
per year. The (HDE) application is similar in both form and content to
a premarket approval (PMA) application, but is exempt from the effectiveness
requirements of a PMA.
CDRH also has available
a number of other databases relating to medical devices and radiation-emitting
products. Information not contained in the CDRH databases must be requested
via a Freedom of Information
request.
|