p style=margin: 0px 0px 20px; padding: 0px; color: #717171; font-family: Calibri, Arial, sans-serif; font-size: 16px;Reducing the complexity of Regulatory submissions, the global Regulatory Authorities transformed all the submissions from paper to electronic format. Respectively, there are several electronic submission formats proposed by country-specific Regulatory bodies. /p
p style=margin: 0px 0px 20px; padding: 0px; color: #717171; font-family: Calibri, Arial, sans-serif; font-size: 16px;Recently, the US FDA issued a new guidance for electronic submission for medical devices, following a draft guidance issued in September 2019. Delineating FDA’s strategies, this new guidance concludes that it is not feasible to describe and implement the electronic formats that would apply to all submissions covered under the statutory requirements of section 745A(b)(3) of the FDA Reauthorization Act of 2017 (FD
p style=margin: 0px 0px 20px; padding: 0px; color: #717171; font-family: Calibri, Arial, sans-serif; font-size: 16px;Recently, the US FDA issued a new guidance for electronic submission for medical devices, following a draft guidance issued in September 2019. Delineating FDA’s strategies, this new guidance concludes that it is not feasible to describe and implement the electronic formats that would apply to all submissions covered under the statutory requirements of section 745A(b)(3) of the FDA Reauthorization Act of 2017 (FD
