Weekly Regulatory News: Oct 7-13, 2024
This week in medical device regulatory news: Brazil expedites registration of IVDs for mosquito-born diseases; new US FDA guidance on endosseous dental implants and abutments.
BRAZIL
ANVISA Prioritizes Registration of Mosquito-Borne Disease Tests
ANVISA has announced a new initiative to expedite the registration of diagnostic tests for diseases caused by mosquitoes, including dengue, chikungunya, and oropouche fever. This prioritization aims to enhance early diagnosis and treatment options for arboviral infections, which significantly impact public health in Brazil, especially during the rainy season when mosquito breeding increases. Effective until December 31, 2024, this measure applies to both new and pending requests for medical devices and Good Manufacturing Practices Certifications. Together, we can combat these diseases—let's all do our part by preventing stagnant water!
Learn more about ANVISA Brazil Medical Device Registration.
UNITED STATES
FDA Releases Guidance on Performance Criteria for Endosseous Dental Implants and Abutments
The FDA has issued new guidance, effective October 15, 2024, outlining performance criteria for endosseous dental implants and abutments under the Safety and Performance Based Pathway. This guidance allows 510(k) submitters to use performance criteria, rather than direct comparisons to predicate devices, to demonstrate substantial equivalence. The document provides recommendations for industry and FDA staff, streamlining the regulatory process while ensuring public health safety. The guidance is immediately applicable but remains open for public comment.
Learn more about FDA US Medical Device Registration.
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