Sometimes, medical device companies do not handle a complaint correctly. Sometimes they do not follow an adequate design control process or misrepresent their device. Sometimes their packing is missing a compliant IFU. And then there are times when all of these things are happening at once. Where a medical device company is simply not operating … Read more
Welcome to this week’s edition of Warning Letter of the Week (WLOTW)! We will be explaining an FDA Warning Letter given to Abbott Point of Care (POC) related to their product “i-STAT cTnI Test”. The warning letter covers issues with design control and 510(k) clearance while including one of the funniest lines I have read … Read more
Welcome to this week’s installation of Warning Letter of the Week (WLOTW). This week, we will be the last article in our series on a Warning Letter issued to Olympus Medical Systems (full Warning Letter). So far, we’ve dived into issues relating to Olympus Medical not properly handling data, not performing re-validation on sterilization processes, … Read more
Welcome to this week’s installation of Warning Letter of the Week (WLOTW). This week, we will be continuing our series on a Warning Letter issued to Olympus Medical Systems (full Warning Letter). Last week, we discussed the first finding listed in the Warning Letter, which was related to not correctly handling NCR and complaint data … Read more
Welcome to this week’s installation of Warning Letter of the Week (WLOTW). Each week we will review a different FDA Warning Letter to gather as much information as possible to avoid repeating those mistakes. The Warning Letters will range from recently posted letters to letters covering specific markets, and anything else we find interesting. If … Read more
Welcome to the first installation of Warning Letter of the Week (WLOTW). Each week, we will review a different FDA Warning Letter, to gather as much information as possible to avoid repeating those mistakes. The Warning Letters will range from recently posted letters to letters covering specific markets, and anything else I find interesting. If … Read more