AssurX Blog
Straight talk for regulated industries.
FDA Warning Letters Hit Device Makers Over CAPA, MDR Failures
It’s been a little while since we checked the FDA’s outgoing mail tray to find out what inspectors are looking for – and often finding. During their visits in the first half of 2015 W [...]
Medical Device Makers Express Optimism About Future – But QA Worries About US Regulatory Burden
Crystal may be clear, but crystal balls, at least metaphorically, are certainly not. The late, great political columnist David Broder with The Washington Post used to run a column at t [...]
FDA 510(k) Approval Process Now Averages Over Six Months
If you’ve got six months – and nerves of steel – here’s some good news: You have a 61% percent chance of getting your medical device approved by the FDA. That’s one nugget of interest [...]
FDA Issues Deadline Reminder to Medical Device Companies on Electronic Medical Device Reporting
Looks like it's crunch time for medical device manufacturers. Whether they submit one or 10,000 medical device reports (MDRs) to the FDA per month, they are required to go all electro [...]
FDA’s Shuren Works to Assure Device Industry Innovators
Calling it something of a “culture change” at the Center for Devices and Radiological Health (CDRH), Director Jeffrey Shuren said his team is working hard to find ways to speed approva [...]
FDA Moves UDI Initiative Further Down the Production Line
We, and others, like to take the FDA to task for missing deadlines or behaving in ways that are sometimes difficult to fathom. But it’s only fair to give equal space to something when [...]
