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Posted On: 04/08/2024 11:11:22 AM
Post# of 85913
It seems like IR Med is extremely close to being approved to sell Pressure Safe in the US. On a side-note, they have several other interesting devices in the pipeline. This should be the beginning of a wonderful partnership IMHO.
What is an FDA listing:
An FDA listing is a regulatory requirement that informs the FDA of the activities performed on a medical device by a medical device establishment. The FDA requires that all medical devices manufactured or imported into the US be listed, including those manufactured by contract manufacturers or sterilizers. The listing process also assigns each device a device listing number.
The FDA classifies medical devices as class I, class II, or class III, with class III being the highest risk category. The terms "listed," "cleared," "approved," and "granted" all refer to a finding or status from the FDA that authorizes a medical device to be legally placed on the market in the US, and these terms are often used interchangeably. However, each term refers to a unique pathway to market that is based on the device's risk class.
The FDA also requires that establishments register, which informs the FDA where an establishment is located. Knowing where devices are made helps the nation prepare for and respond to public health emergencies.
Owners or operators can update their registration and listing information through the FDA Unified Registration and Listing System (FURLS) at any time. Examples of changes to listings include introducing another device into commercial distribution, a change to a previously listed device, or removing a previously-listed device from commercial distribution.
What is an FDA listing:
An FDA listing is a regulatory requirement that informs the FDA of the activities performed on a medical device by a medical device establishment. The FDA requires that all medical devices manufactured or imported into the US be listed, including those manufactured by contract manufacturers or sterilizers. The listing process also assigns each device a device listing number.
The FDA classifies medical devices as class I, class II, or class III, with class III being the highest risk category. The terms "listed," "cleared," "approved," and "granted" all refer to a finding or status from the FDA that authorizes a medical device to be legally placed on the market in the US, and these terms are often used interchangeably. However, each term refers to a unique pathway to market that is based on the device's risk class.
The FDA also requires that establishments register, which informs the FDA where an establishment is located. Knowing where devices are made helps the nation prepare for and respond to public health emergencies.
Owners or operators can update their registration and listing information through the FDA Unified Registration and Listing System (FURLS) at any time. Examples of changes to listings include introducing another device into commercial distribution, a change to a previously listed device, or removing a previously-listed device from commercial distribution.
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