FDA Reauthorization Act of 2017

[AI summary unavailable — showing source text] FDA Reauthorization Act of 2017 Prescription Drug User Fee Amendments of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to extend through FY2022 and revise Food and Drug Administration (FDA) user fees for new drug applications. User fees are eliminated for supplements to new drug applications and drug manufacturing facilities. Medical Device User Fee Amendments of 2017 The bill extends through FY2022 and revises FDA user fees for medical devices. A user fee is established for requests to classify devices that are not substantially equivalent to marketed devices. The FDA is no longer granted the discretion to waive or reduce fees in the interest of public health. The FDA must establish a pilot program to accredit testing laboratories to determine whether medical devices conform to performance standards. The bill revises the types of medical devices that the FDA may accredit third parties to review. Generic Drug User Fee Amendments of 2017 The bill extends through FY2022 and revises FDA user fees for generic drugs. User fees are eliminated for supplements to generic drug applications. An annual fee is assessed on holders of approved generic drug applications. Biosimil…