OBJECTIVES: The Affordable Care Act (ACA) has introduced several major changes which can impact product pricing, access and uptake in the United States. The objective of this analysis was to review all major new changes due to ACA and develop implications for market access for medical products.METHODS: The new pricing, access and coverage changes impacting the pharmaceutical and devices products were reviewed using the bill for ACA (H. R. 3590), 2011-2015 policy publications, reports by the Congressional Budget Office and Government Accountability Office, and the latest Centers for Medicare & Medicaid Services (CMS) guidelines for Essential Health Benefits (EHBs). Primary discussions with US private payers and ex-CMS policy experts were conducted to understand key issues for medical products. RESULTS: The ACA has introduced major changes for product pricing, deductible, coverage and uptake.  For pricing, major changes are a 50% discount for Part D population and an increased rebate of 23.1% for the Medicaid population. For deductibles, the patient costs are capped at $12,700. For uptake, an additional population is eligible based on expanded access to 30 million uninsured Americans, with more than half of them being under the age of 35 years (~59%). For access, the 2014 definition of Essential Drug Benefits is likely to either expand or reduce coverage depending upon the state and class of drugs. For example, for NSAIDs in CA only 20 drugs are covered, while in NY, 40 drugs are covered. During 2012-2014 Accountable Care Organizations (ACOs) have increased to ~600 organizations covering ~18 million lives, which has created a new stakeholder of an integrated provider-payer partnership. CONCLUSIONS: ACA has introduced major changes which will have a significant impact on converge, pricing and access of pharmaceutical and device products.