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  • Updated Electronic Submission Guidance for Device Manufacturers Reflects FDA's 'Experience to Date'

    US medical device regulators have released a newly updated guidance document on the submission of electronic copies of device submissions under a program known as "eCopy," expanding the guidance by several pages to include "clarifications" based on the agency's "experience to date with the program." The eCopy program was brought into law under Section 745A9b) of the Food and Drug Administration Safety and Innovation Act (FDASIA) . As explained by FDA, "An electronic co...
  • Draft Guidance Establishes Accreditation Process for Third-Party Medical Device Reviews

    A new draft guidance document from the US Food and Drug Administration (FDA) regarding the accreditation process for firms utilizing its Third Party Review Program (TPRP) aims to establish a regulatory framework that can later be harmonized with one under development by the International Medical Device Regulator's Forum (IMDRF). Background In October 2012, IMDRF , a regulators-only medical device harmonization group that succeeded the Global Harmonization Task Force ...
  • FDA Releases Guidance Document on Soon-To-Be-Mandatory Device Submission Program

    The US Food and Drug Administration (FDA) has released a new draft guidance document on a new digital medical device submission system. The system, known as the eCopy Program, is soon to be required of certain manufacturers under the terms of the recently passed FDA Safety and Innovation Act (FDASIA) , Section 745A(b). As explained by FDA, "An electronic copy (eCopy) is defined as an exact duplicate of the paper submission, created and submitted on a CD, DVD, ...