FDA/MDUFMA Articles
The
Right Way is also the Best Way: A Medical Device Manufacturer’s FDA Quality Assurance Program
by H. Stephen Brown, Chief Manager, Chain of Trust,
LLC
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General
Controls: Establishment Registration and Device Listing
Manufacturers of
ALL classes of medical devices are required to register their
establishments and list devices that are intended for commercial
distribution in the U.S.
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Are
You Confident That Your Device Is Correctly Classified?
Device classification
is an important step in the regulatory process. The class
that your device falls under determines what type of premarket,
if any, submission is required for FDA clearance. Medical
devices are classified into Class I, II, or III depending
on level of risk (Class I is generally lowest risk, Class
III is highest), intended use, and indications for use. Regulatory
requirements vary for the different classes of device; they
are lowest for Class I devices and highest for Class III devices.
FDA has established classifications for over 1,700 different
generic types of devices. As a manufacturer, you need to determine
what generic device category your device falls under in order
to determine its class.
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