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 […]
ANVISA updates economic monitoring requirements for some medical devices
ANVISA has issued new regulations about economic monitoring of certain device types in order to boost transparency and establish reference pricing for these products. The regulation, RDC 478/2021 (link in Portuguese), slated to take effect April 1, 2021 revokes economic monitoring and reporting processes previously established under RDC 185/2006, and initially reduces the number of medical device types for […]
Health Canada clears its stand on Research-Use Only COVID-19 Tests
Health Canada have released a notice on research use only Covid tests and clarified its stand. The “For Research Use Only” labeled devices shall be used only in the laboratories during the development phase or for pilot testing and cannot be used either for clinical trial or commercial testing or for sale. The In-vitro diagnostic […]
Ministry of Health and Family Welfare, India propose use of American Standard Test Methods for medical device conformance
India’s Ministry of Health and Family Welfare has proposed recognizing American Standard Test Methods (ASTM) as acceptable tools for demonstrating conformance of medical devices to safety and conformance requirements and obtaining market access in the country. The notification would amend India’s Medical Device Rules, 2017 to allow medical device market applicants to use ASTM methods to demonstrate […]
Australia’s Therapeutic Goods Administration publishes guidance on clinical decision support software exemptions
Australia’s TGA is currently reforming the regulation of software-based medical devices, with an amendment that introduces significant regulatory carve-outs taking effect this week after being postponed due to the COVID-19 pandemic. In support of the changes found in the amendment, the TGA has published guidance on the regulation of clinical decision support software (CDSS) on its website. This guidance document has been […]
Australia’s Therapeutic Goods Administration carves out exemptions for some software-based medical devices
TGA has published the Therapeutic Goods (Excluded Goods) Amendment (Software-Based Products) Determination 2021, which will become effective on February 25, 2021. This amends the Therapeutic Goods (Excluded Goods) Determination 2018 to identify software-based devices, including software as a medical device (SaMD), that are excluded from the TGA’s medical device regulatory framework and should not be included in the […]
CFDA announces classification adjustments and UDI submission guidelines
CFDA have announced two important medical devices regulatory, first about the classification changes, and the second regarding the submission of unique device identifier (UDI) data. Adjustments in classification catalog NMPA has partially revised the Medical Device Classification Catalog, as discussed in Announcement No. 147 of 2020 (link in Chinese). Considerable changes include down-classification of 15 device types […]
US FDA: guidance for abbreviated 510(k) programs finalized, updates Refuse to Accept policy
The US FDA’s Center for Devices and Radiological Health (CDRH) has issued final guidance for its Abbreviated 510(k) premarket notification pathways following proposals in 2018 to expand access to these programs, as well as its Refuse to Accept policy for inadequate or incomplete 510(k) submissions. Abbreviated 510(k) program for faster FDA clearance FDA and CDRH […]
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 […]
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