Tag

submissions
FDA issued a draft guidance for comment: Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Contains Nonbinding Recommendations Draft – Not for Implementation Equivalence through Performance Criteria. The outline shows a Section 17 for software information. The outline can be viewed here.
Read More
FDA issued a new draft guidance entitled”Draft Guidance for Industry; How To Prepare a Pre-Request for Designation”. This guidance is intended to describe informal interaction with FDA that might lead to a formal Designation request to determine wether a product will be regulator as a device or a drug and some combination thereof. The full...
Read More
http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm313794.pdf
Read More
/docs/FDApremarketclassificationcodexemptionsAug2015.pdf
Read More
http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/ucm370879.htm
Read More
/docs/FDAEvaluatingSubstantialEquivalenceGuidance0714.pdf
Read More
http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm383206.htm#s5
Read More
http://www.fda.gov/downloads/ForIndustry/FDAeSubmitter/UCM319824.pdf
Read More
This topic contains a number of FDA guidances and SoftwareCPR training aides related to preparation of software information in premarket submissions for FDA including 510(k)s, PMAs, and IDEs.
Read More
Expand your access! Subscribe today!

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.