FDA CDRH Inspection Guide Lists FDA SW Contacts

The final Device Center Inspection Compliance Policy Guide (provided at the link above and in the Library on this site) Part VI, Page 11, lists the following as points of contact related to software:

“i. Questions regarding compliance of product software, stand alone software, process equipment software or the Year: 2000 Problem:
Stewart Crumpler
Office of Compliance Software Expert, HFZ-340
Telephone: (301) 594-4659 ext. 119”

Mr. Crumpler is also listed along with Paul Motise of ORA as contacts for Part 11 Electronic Records;Signatures questions.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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