You’ve received “the call” from the FDA auditor. After an understandable quick moment of panic, what should your next steps be?
Topics: BIMO Checklist, FDA Audit
You’ve received “the call” from the FDA auditor. After an understandable quick moment of panic, what should your next steps be?
Topics: BIMO Checklist, FDA Audit
You’ve received “the call” from the FDA auditor. After an understandable quick moment of panic, what should your next steps be?
At IMARC, we have participated in the audit preparation process for numerous sites who have been contacted for an FDA audit. It is helpful for a site to know what the FDA auditor will use during their review. In a past blog, we discussed a new document introducing a standardized Nonconformity Grading System, which was created by the former Global Harmonization Task Force (now re-named International Medical Device Regulators Forum) to assist regulatory authorities and auditing organizations.
Topics: BIMO Checklist, FDA Audit
Merriam Webster defines a case study as a published report about a person, group, or situation that has been studied over time; also : a situation in real life that can be looked at or studied to learn about something. Case studies can be useful to help highlight how to handle a particular situation, including the eventual outcome.
Topics: Case Study, FDA Audit, Trust the Process
Merriam Webster defines a case study as a published report about a person, group, or situation that has been studied over time; also : a situation in real life that can be looked at or studied to learn about something. Case studies can be useful to help highlight how to handle a particular situation, including the eventual outcome.
Topics: FDA Audit, FDA Inspection, BIMO
In order to better understand the CDRH’s review of submissions that were found to be Not Substantially Equivalent (NSE), FDA published on its website the initial results of 510(k) audit as part of the Action Plan implemented in January 2011. The determination of NSE not only is an inefficient use of FDA’s time and resources, but can also be a costly delay for industry. With this information and analysis now available, the goal is for sponsors to understand the reasons the NSE determination resulted, as well add some clarification to the process.
