Glossary Term
Approval Pathway
Definition
An Approval Pathway refers to the regulatory process a medical device, drug, or therapy must undergo to gain market authorization from a governing body, such as the FDA in the U.S. or the European Medicines Agency (EMA) in the EU. The pathway determines the steps required based on the product’s risk classification, intended use, and technological novelty.
Relevance to the MedTech Industry
The Approval Pathway ensures that medical devices meet stringent safety, efficacy, and quality standards before reaching the market. It provides a structured framework for evaluating the device’s compliance with regulatory requirements, fostering patient safety and public trust in MedTech innovations. In the US, device manufacturers must decide between a range of possible pathways offered by the FDA: Pre-Market Approval (PMA), 510(k), De Novo, Humanitarian Device Exemption (HDE), Breakthrough, Expedited Access, or Investigational Device Exemption (IDE).
Additional Information & Related Terms
510(k) Clearance A common FDA Approval Pathway for demonstrating substantial equivalence to a predicate device.
De Novo Classification Request An FDA pathway for novel, low- to moderate-risk devices with no predicate.
Premarket Approval (PMA) A rigorous FDA process for high-risk devices requiring extensive clinical data.
Post-Market Surveillance Ongoing safety and efficacy monitoring required by many Approval Pathways.