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Medical Devices › EAP

Morgan Lewis

21st Century Cures Act and Medical Device Regulatory Pathways

Morgan Lewis on

These seven key provisions will affect the premarket requirements for medical devices. The US Senate passed the 21st Century Cures Act on December 7, and President Barack Obama is expected to sign the bill into law....more

Knobbe Martens

FDA’s Expedited Access Program: A Year in Review

Knobbe Martens on

A new blog post by The Food and Drug Administration (FDA) published earlier this month provides an update regarding the implementation of the year-old Expedited Access Pathway (EAP) program, which was created in April 2015 by...more

King & Spalding

FDA Initiates Expedited Access Pathway Program for Medical Devices via Final Guidance Document

King & Spalding on

The U.S. Food and Drug Administration (FDA) initiated an Expedited Access Pathway (EAP) Program, effective April 15, 2015, for certain medical devices that are subject to premarket approval applications (PMAs) or de novo...more

Knobbe Martens

Expedited Access Program Begins For Medical Devices

Knobbe Martens on

On April 15th, the U.S. Food and Drug Administration (FDA) began its Expedited Access Program (EAP), which is designed to get certain medical devices to market sooner. Under the EAP program, device sponsors collaborate...more

Saul Ewing LLP

FDA Seeks Comments for Draft Guidance Regarding Expedited Access for Premarket Approval of Medical Devices Intended for Unmet...

Saul Ewing LLP on

The Food and Drug Administration (FDA) released a draft guidance on April 23, 2014 titled Expedited Access for Premarket Approval [of] Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly...more

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