Medical Device Regulatory Intelligence Blog
 

US FDA has published over 95 new guidance documents in 2019 alone. See the list here: https://www.fda.gov/drugs/guidance-compliance-regulatory-information and count on Thomas Regulatory Resolutions for your medical device #consulting needs in #regulatory #qms #meddevice #medicaldevice #fda #ISO13485 #510k #medtech #usagent

The FDA recently issued a draft guidance titled Nonbinding Feedback After Certain FDA Inspections of Device Establishments, a requirement under the FDA Reauthorization Act of 2017 (FDARA). The draft guidance proposes a process by which companies can request from the FDA nonbinding feedback on certain kinds of documented inspectional observations...