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Glossary Term
Equivalence in 510(k) Submissions
Definition
Equivalence in 510(k) submissions refers to the demonstration that a new medical device is substantially equivalent to a legally marketed device (predicate device) in terms of safety, effectiveness, and intended use. This is a key requirement for obtaining FDA clearance under the 510(k) pathway, which allows manufacturers to market devices without undergoing a full premarket approval (PMA) process.
Relevance to the MedTech Industry
The concept of equivalence streamlines regulatory approval by enabling manufacturers to leverage existing devices as benchmarks. It accelerates market entry for new products while maintaining safety and efficacy standards, fostering innovation without duplicating extensive clinical testing.
Additional Information & Related Terms
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