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Description
Assuming any necessary clinical data is already available and does not need to be gathered, many companies find that compiling a premarket application (PMA) for a high-risk device often takes 12-24 months, a de novo is 9-12 months, and a 510(k) is 4-6 months

doi: 10.1007/978-981-13-1435-3_12 56

[42] The first six amino acids of GLP-1 are missing

doi: 10.1038/s41387-021-00161-4

Pharmaceutics 13 (2), 211
