Plans and documentation to tidy RAW data in Maude?

Question

MAUDE is the Manufacturer and User Facility Device Experience database from the FDA.

The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters 1 (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.

What are the plans for documenting how MAUDE is tidying its databases? I noticed that RAW data has been recently converted to ALL CAPS, separators changed, and the first row changed. What other changes are happening to RAW data set and where is this history being documented?

Here's an example from FOIDEV2010

"215"|"1939345"|"1969891"|"N"|"V"|"1"|"12/22/2010"|"UNK DEPUY ASR IMPLANTS"|"87KWA"|"DEPUY INTERNATIONAL, LTD."|"ST ANTHONYS RD||LEEDS||||UK|LS11 8DT||NA|UNK|UNK|NA|0HP|N||KWA|DA|R|||||||||||||||||

1939343|1970001|N|V|1|12/22/2010|UNK DEPUY ASR IMPLANTS|87KWA|DEPUY INTERNATIONAL, LTD.|ST ANTHONYS RD"|""|"LEEDS"|""|""|""|"UK"|"LS11 8DT"|""|NA|"UNK"|"UNK"|NA|"0HP"|"N"|""|"KWA"|"DA"|"R"|""|""|""|""|""|""|""|""|""|""|""|""|""|""|""|""|""

Why is the new INDEX in col 1 added where it wasn't before? And why must I write this publicly when I would prefer submitting it in a more private email which is a more appropriate forum for observations like this!

Answer 1

I haven't seen any "plans" per se from FDA but have noticed that they have split up the MAUDE database into separate components. There is a MASTERLIST but the PATIENT_NARRATIVE has been split off into another set of files.

I have been poring over MAUDE in efforts to extract "significant unanticipated adverse effects". Such events trigger strict reporting and distribution timelines. However, when a clinical trial is conducted under an Investigational Device Exemption (IDE) (as many are), the FDA doesn't seem as interested in ensuring regulatory compliance.

Perhaps the FDA is not interested because such delays can trigger statutory fines for each additional day of violation.