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Hi Michelle, Typically the following FDA site is a good starting for such information. Would be interested to know more about your search engine. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm Umang Shah PhD ​ ------------------------------ Umang Shah PhD, RAC US Head Regulatory CMC Biologics Marietta GA United States ...

Hi everyone, Does anyone have any experience writing the design philosophy section of a HC medical device submission? If so, is there a template for this section? How detailed does the section have to be?  Anyone have experience to share? Thanks. ------------------------------ Karen Zhou ------------------------------

Here is more context from Apple. 1.4 Physical Harm If your app behaves in a way that risks physical harm, we may reject it. For example: 1.4.1   Medical apps that could provide inaccurate data or information, or that could be used for diagnosing or treating patients may be reviewed with greater scrutiny. Apps must clearly disclose data ...

There may be more going on here than I encompass in my answer. If so, please provide additional information. First, you say this is an investigation device with an IDE. I infer this means Part 812 and not an RUO or IUO. You should treat the lab as any other vendor, meaning 820.50. You will establish the requirements, evaluate, selected, keep records, ...

Hi RegEx, It's hard to believe we are almost at the end of Convergence! I hope you have all enjoyed learning throughout the various sessions. It's great to see that the strength of the regulatory community is alive and well even in a virtual environment.  I want to highlight this year's RAPS Awardees and Fellows .The recipients are individuals ...