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Understanding the FDA's regulatory system is the first objective for device manufacturers looking to sell in the U.S. The 510(k) Premarket Notification submission should be prioritized when developing a medical device. This pathway provides marketing clearance and the ability to sell your medical devices in the U.S. Before sales can occur companies have two options: 510(k) Premarket Notification (unless exempt); or Premarket Approval (PMA) approval. PMA’s are resource intensive, and so 510(k)’s are the ideal submission type.
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|Section 1: Classification|
Properly classify your medical devicePreview
|Section 2: Substantial Equivalence|
Identify a predicate device
|Section 3: Types of 510(k)|
Prepare 510(k) submission content
|Section 4: Labeling & Performance Testing|
Allocate resources for product development
|Section 5: Timelines & Important Considerations|
Save resources by utilizing key insights
QUALITY REMEDY provides regulatory support, quality management consulting, and product development solutions to medical device companies. As a regulated industry, medical device development is a complex world. This sector requires strict processes, robust records, internal/external auditing and much more in order to demonstrate product safety and effectiveness. Let us help you abide by the constantly evolving guidelines.