Australia and Oceania
The Therapeutic Goods Administration (TGA) provided a set of detailed guidance documents to assist medical device manufacturers in achieving and sustaining compliance with regulatory requirements to be allowed for marketing in Australia – the Australian...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG) has published a Q&A dedicated to conformity assessment procedures for protective equipment. The document has been developed to provide the manufacturers and other parties involved with additional information to achieve...
FDA
The Food and Drug Administration (FDA) has published the draft guidance dedicated to the principles for selecting, developing, modifying, and adapting patient-reported outcome instruments for use in medical device evaluation. Scope of the guidance According to the...
FDA
The Food and Drug Administration (FDA) has proposed an amendment to the non-invasive bone growth stimulators classification rules. The document has been published in the Federal Register. Non-Invasive Bone Growth Stimulator Devices: Brief Description Non-invasive bone...
EU MDR/IVDR
The European Commission (EC), a legislative body of the European Union, has adopted a regulation dedicated to the common specifications for the reprocessing of single-use devices. Regulatory Background The new Commission Implementing Regulation (EU) 2020/1207 is...
COVID-19
The Food and Drug Administration (FDA) has issued a special warning describing the risk for patients associated with the protective barrier enclosures without negative pressure used in the context of the Coronavirus Disease 2019 (COVID-19) caused by the virus...
