http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/ucm080235.htm

Deciding When to Submit a 510(k)

Compliance Consultants can guide you through the early process and educate you to make confident decisions regarding:

• Prototype vs production (devices & documentation)
• What documentation is required
• What harmonized standards must be complied (and should be later on) with to file a 510(k)?
• Verification vs Validation Tests
• When is clinical data required?
• Even if the software is a MINOR level of concern according to the Software Reviewers Guide, will the FDA allow you to develop anything less than software documentation for a MODERATE level of concern