Would you like an extra application with that? FDA mulls requiring dual applications for combination products
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FDA’s Proposed New Pathway for Devices Referencing Drugs (DRDs)
The Food and Drug Administration (FDA) may be closing in on solving one of its perennial regulatory problems, namely, the absence of a workable regulatory pathway for devices that seek to use older, mainly generic drugs in innovative ways. Under the current system, where a device sponsor proposes to label its device for use with a drug in a manner that may go beyond the existing drug labeling, FDA typically requires the submission of a…
FDA Requires Reprocessing Validation Data for Certain Reusable Devices
On June 9, 2017, the U.S. Food and Drug Administration (“FDA”) published a Federal Register Notice announcing that new 510(k) notices for a number of reusable medical devices will now require the support of validated instructions for use and reprocessing instructions addressing cleaning, disinfection, and sterilization. Although the Notice was required by Section 3059 of the 21st Century Cures Act, it is consistent with FDA’s recent focus on reprocessing activities in response to public health…
FDA Pushes UDI System Compliance Date Back for Class I and Unclassified Devices
On June 2, 2017, the U.S. Food and Drug Administration (FDA) announced in a letter to device labelers that it will issue a guidance document stating that FDA will exercise its enforcement discretion for the unique device identifier (UDI) compliance date for certain class I devices which are subject to current Good Manufacturing Practice (cGMP) requirements and unclassified devices. Under the planned guidance, devices in these categories will now have an additional two years to…
FDA Offers New Recommendations for Interoperability of Connected Devices
On January 26, 2016, the Food and Drug Administration (FDA or the Agency) released a draft guidance document, Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices (Draft Guidance).
Read More: FDA Offers New Recommendations for Interoperability of Connected Devices…
New EMC Guidance Released by FDA
On November 2, 2015, the Food and Drug Administration (FDA) released a draft guidance document, “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices,” describing the types of EMC information that should be provided in a premarket submission for electrically-powered medical devices.
Read More: New EMC Guidance Released by FDA…
FDA Offers Clarity of UDI Application to Kits
On January 4, 2016, FDA officially released a draft guidance document Unique Device Identification: Convenience Kits, with further information regarding the Unique Device Identifier (UDI) requirements for labeling and data submission for kits.
Read More: FDA Offers Clarity of UDI Application to Kits …
FDA Publishes Final Unique Device Identifier Rule for Medical Devices
The U.S. Food and Drug Administration (FDA or the agency) issued the final Unique Device Identifier (UDI) rule on Tuesday 24 September 2013, following up on the draft rule previously circulated by the agency on 3 July 2012.
Overview of the UDI requirements
With limited exceptions, the rule requires that medical devices are labeled with a UDI in both a plain text format and in a format that uses automatic identification and data capture (AIDC)…