2 ms·

Wow, awesome work! It's crazy to think about how the FDA itself probably can't answer a question like "how many predicates does device X have", but I guess also

by bogwog 2y ago

Wow, awesome work! It's crazy to think about how the FDA itself probably can't answer a question like "how many predicates does device X have", but I guess also on brand with the idea that government is incompetent more often than not. Trying to enact a policy that a limits the number/age of predicates in a 501(k) application is impossible if you have no way to find them!

s1artibartfast 2y ago
>Wow, awesome work! It's crazy to think about how the FDA itself probably can't answer a question like "how many predicates does device X have" Im not sure why you would think that. The answer would take 5 minutes to answer with the PDFs (which is where the parent post got the info).
- wcedmisten 2y ago
  For this particular device, there were 40 devices in the ancestry tree. While certainly feasible to traverse a graph of 40 PDFs and keep track of these relationships, it would probably take more than 5 minutes. Additionally, not having the data in a structured format prevents seeing overall trends in the data.
  - s1artibartfast 2y ago
    I agree it would take longer to map them all. This is fine if you never need or want to map them. I've worked in this industry for 15 years and I have never had a need to do it. The FDA already has information on product codes. here is the one for this device [1]. What is the useful trend and data one gets from grouping an iPhone app with a physical test strip for measuring glucose. I think there is a lot of confusion in the general public about the 510k process is and what substantial equivalence means. Product drift is an intentional feature of the process, not a bug. 510k filing is not intended to be a single point control for safety and efficacy, but is implemented in context of other controls like medical device reporting and quality management. Devices are primarily regulated at the device level, sometimes at the group level, but never at the lineage level. Im not sure what it would mean to trend and regulate as a lineage. Would that mean recalling a safe and effective product because of bad ancestor? https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTPLC/tplc.cfm?id=QFG&min_report_year=2023 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTPLC/tp...

by bogwog 2y ago

s1artibartfast 2y ago

>Wow, awesome work! It's crazy to think about how the FDA itself probably can't answer a question like "how many predicates does device X have" Im not sure why you would think that. The answer would take 5 minutes to answer with the PDFs (which is where the parent post got the info).

wcedmisten 2y ago
For this particular device, there were 40 devices in the ancestry tree. While certainly feasible to traverse a graph of 40 PDFs and keep track of these relationships, it would probably take more than 5 minutes. Additionally, not having the data in a structured format prevents seeing overall trends in the data.
- s1artibartfast 2y ago
  I agree it would take longer to map them all. This is fine if you never need or want to map them. I've worked in this industry for 15 years and I have never had a need to do it. The FDA already has information on product codes. here is the one for this device [1]. What is the useful trend and data one gets from grouping an iPhone app with a physical test strip for measuring glucose. I think there is a lot of confusion in the general public about the 510k process is and what substantial equivalence means. Product drift is an intentional feature of the process, not a bug. 510k filing is not intended to be a single point control for safety and efficacy, but is implemented in context of other controls like medical device reporting and quality management. Devices are primarily regulated at the device level, sometimes at the group level, but never at the lineage level. Im not sure what it would mean to trend and regulate as a lineage. Would that mean recalling a safe and effective product because of bad ancestor? https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTPLC/tplc.cfm?id=QFG&min_report_year=2023 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTPLC/tp...