ANVISA – Public Consultation No. 586 of 12/20/2018 – Proposal for Normative Ruling on the Quality Assurance Guidelines for Validation, Monitoring and Routine Control of…
Posts published in December 2018
ANVISA – Public Consultation No. 585 of 12/20/2018 – Proposal of Resolution of the Collegiate Board of Directors – RDC, which provides for the requirements…
ANVISA – Public Consultation nº 584 of 12/20/2018 – Framework of medical device as single use or reusable ANVISA – Consulta Pública nº 584 de…
MedTech Europe Statement on the Implant Files
Interesting findings – “results of the computer-simulated VICTRE trial are consistent with the comparative trial using human subjects and human image interpreters. While further research…
USFDA warns about safety risks of teething necklaces, bracelets to relieve teething pain or to provide sensory stimulation Alerta de segurança – USFDA adverte sobre…
Interesting findings and recommendations – Medical Device User Fee Amendments IV Independent Assessment of Food and Drug Administration’s Device Review Process Management – Final Report…
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the long-term safety oversight of the Essure device following discontinuation of its U.S.…
Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses
MDSAP Stakeholder Day Presentations – December 5, 2018