Alternative spellings: pre-market approval application, premarket approval application An application made by the manufacturer to the Food and Drug Administration (FDA) for approval to market a medical product in the United States. Note: This application includes the pertinent information documenting the safety and effectiveness of the product.

and • provides information on costs and financial impact. Note 2: The report may optionally discuss organisational considerations. Note 3: A “mini-HTA” may be as rigorous as an HTA report but typically has a restricted scope and so is quicker to produce. Note 4: Related terms include health technology, HTA report, rapid review, level of evidence