Newsletter - August 3, 2017
FDA Takes a Developer-Friendly Approach to Regulating Software
Last week FDA announced one of the biggest reshuffle in its policies for regulating software that should drastically reduce pre-approval regulatory burden on the developers and focus resources on evaluation of post-market consumer use data. FDA will change its traditional process for software as a medical device (SaMD)..Read More
Automated System Improves FDA Clearance of Imports as Expected
About two years ago, in 2015, FDA launched an automated system for importers to submit shipment information for custom and FDA clearance and it has almost tripled the number of shipments that are cleared within minutes of arrival at the US ports allowing inspectors to quickly find the riskier shipments and focus their resources on managing them. Read More
FDA Takes a Developer-Friendly Approach to Regulating Software
Last week FDA announced one of the biggest reshuffle in its policies for regulating software that should drastically reduce pre-approval regulatory burden on the developers and focus resources on evaluation of post-market consumer use data. FDA will change its traditional process for software as a medical device (SaMD)..Read More
Automated System Improves FDA Clearance of Imports as Expected
About two years ago, in 2015, FDA launched an automated system for importers to submit shipment information for custom and FDA clearance and it has almost tripled the number of shipments that are cleared within minutes of arrival at the US ports allowing inspectors to quickly find the riskier shipments and focus their resources on managing them. Read More
