Guideline

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Draft Guidance: Likelihood of Facilities Inspections When Modifying Devices Subject to Premarket Approval
Internet:	http://www.fda.gov/cdrh/comp/likehood.pdf
Origin/Publisher:	FDA http://www.fda.gov/cdrh/comp/likehood.pdf
Content:	This draft guidance document will help firms determine whether a FDA inspection is needed and more easily manage the time frames associated with implementing changes in manufacturing facilities, manufacturing methods or procedures, labeling, design or performance.
Status:	Draft
Document Type:	Guideline