US FDA outlines next steps following COVID-19 PREPP
The US FDA have made an announcement followed by issuing a summary report on findings of a third-party review of the agency’s pandemic response efforts, the PREPP which was undertaken from July to December 2020. Based on the summary report findings as well as current FDA priorities and responsibilities, the agency will initially focus on five PREPP-related efforts. The […]
US FDA issue an EUA over imported Non-NIOSH Approved respirators
US FDA has reissued one of its Emergency Use Authorizations (EUAs) covering imported respirators that have not been approved by the National Institute for Occupational Safety and Health (NIOSH). The “Umbrella EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs)” continues to be valid, but the FDA is now restricting its use to previously authorized […]
US FDA issues detailed Framework for the Safety and Performance Based Pathway for abbreviated 510(k) medical device review
As a first step towards operationalizing of the Safety and Performance Based Pathway, the FDA has issued draft guidances identifying performance criteria and testing methodologies for certain devices within five class II device types. The FDA expects to operationalize this pathway once the first device types and applicable performance criteria have been identified and final […]
USFDA updates on hike in user fees for the 2020 fiscal year
US Food and Drug Administration medical device have increased the user fees by about six percent for 510(k) premarket notifications, Premarket Approvals (PMAs) and other market registration applications for the 2020 fiscal year. FDA’s user fee schedule for 2020 shall take effect from October 1, 2019, and entails six-percent increases for both standard and small-business rates. The […]
US FDA finalizes Safety and Performance 510(k) registration route
FDA’s final guidance on what the agency calls its Safety and Performance Pathway is based on the Abbreviated 510(k) Program; FDA first announced plans to expand the Abbreviated 510(k) Program and published draft guidance in early 2018. Through this market authorization pathway, qualifying device manufacturers would be able to utilize performance criteria identified and approved by FDA to demonstrate […]
US FDA issues a new rule that addresses post-market safety reporting obligations for combination products
USFDA has issued a final rule establishing the post-market safety reporting requirements specifically for combination products. These regulations for drugs, devices, and biological products share many similarities, however, each set of regulations has certain unique reporting requirements, standards and timeframes based in part on the characteristics of the type of product. The FDA’s new rule […]
USFDA extends deadline for UDI Compliance for Class II device labelers
US Food and Drug Administration have notified labelers of some Class II devices that the deadline for Unique Device Identification (UDI) compliance has been extended to September 201.8. This extension affects three broad categories of devices, all of which now have a compliance date of September 24, 2018 for UDI labeling as well as Global Unique Device Identification […]
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