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Overview: Adverse effects reporting (Part I)

Jun 25, 2015 | News

With the issuance last Fall of the US Food and Drug Administration (FDA) draft guidance entitled FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs), the agency has put manufacturers of LDTs on notice that they must begin notifying the...

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Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling

In October 2019, FDA released a guidance suggesting new labeling and performance testing relative to 510(k) premarket notification submissions for coronary, peripheral, and neurovascular guidewires under the product codes DQX and MOF. According to FDA, these new recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of these medical device submissions in accordance with FDA regulatory compliance. The Agency has stated that these...
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New Unique Device Identifier Deadline Approaches

A Unique Device Identifier (UDI) is a numeric or alphanumeric code that is assigned to a medical device. These codes are entirely unique, designed as a method to easily identify and determine the use of devices sold in the United States and Europe. The purpose of a UDI is to enable the regulatory agencies, industry, device users, and healthcare systems to be able to recognize devices from manufacturing through distribution to patient use. In the U.S., in an effort to improve the process for...
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New FDA Guidelines Affect Labeling Consideration for Intravascular Devices with Lubricious Coatings

Since their introduction two decades ago, hydrophilic and hydrophobic coatings on intravascular devices such as catheters, wires, and delivery systems have proven highly popular for decreasing the frictional force when the devices are introduced into the vasculature. By reducing the force required to manipulate intravascular medical devices during vascular interventional procedures, these coatings reduce the risk of damage to blood vessel walls and prevent vasospasm. According to the...
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