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Race was recoded to include: (1) White (55.4%), (2) Black (21.6%), (3) Asian (includes Chinese, Japanese, Filipino, and Other Asian) (5.1%), (4) Hispanic (15.1%), and (5) Other (includes American Indian, Hawaiian, Alaskan Native, Other, and Mixed Race) (2.8%)

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69 Following this, a manufacturer must submit a report detailing the minor modification and establishing that FDA has determined that the product is exempt from demonstrating substantial equivalence to a predicate product

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