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Monday, June 17, 2024 1:09:52 PM
Some company might. My understanding is that when a company’s FDA - cleared product patent expires, another entity cannot use the existing clearance(s) by simply replicating the product. They must submit a new application(s) for FDA clearance that complies with current regulations and guidelines.
How long would that process take?
BIEL has 5 FDA clearances inclusive of musculoskeletal.
Who in their right mind would go through seeking clearances, especially given the NOPAIN Act and possible CMS insurance being right around the corner?
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