Classification of certain medical devices may be predisposed to ambiguities related to which classification type (I, II, or III) they belong too. The three FDA classification types for medical devices are: I – general control, II – special controls including general controls or III – premarket approval including general controls . Proper definition of the classification in which the medical device belongs to is necessary for FDA compliance. In the case that the medical device has an indeterminate classification, a 513(g) can be exercised to request FDA guidance for its proper classification.
Failure Mode Affect and Analysis
FMEA is an acronym that stands for Failure Mode Effect and Analysis which is a method for determining any and all possible points of failure in a design, process, or product. This is a combination of Failure Modes, which is a way in which something could potentially fail and result in defects, and an Effects Analysis which determines the consequences of those failures. During this, failures are prioritized by how serious their consequences are, their frequency, and how they are detected. Failures are eliminated based on their priority, starting with the higher priorities.
Choosing a Predicate Device
One of the critical choices for staying on the premarket notification, the 510(k) pathway, is choosing the...
FDA’s STeP Program
The FDA’s Breakthrough Devices Program is for certain medical devices that provide treatment or diagnosis of...
Advancements in the FDA’s Safety and Performance Based Pathway
One of the FDA’s initiatives for 2021 is to streamline the 510(k) pathways, allowing more efficient access to new...