Tag: submission

By - SebastianFeye

New premarket submission route: FDA’s eSTAR Program from pilot to production by Oct 1, 2023

In September of 2018, the FDA took their first step to improve and modernize the process of a 510(k) electronic submission. This commitment was established as part of the Food and Drug Administration Safety and Innovation Act (FDASIA) that was enacted on July 9, 2012, amending the FD&C Act by adding section 745A. As part of this Act, a program

Tagged : device, eCopy, electronic, FDA, Guidance, Health Canada, medical, modernization, PDF, Pilot, premarket, process, Program, submission

By - SebastianFeye

New Medical Device Pathway: Safety and Performance Based Pathway

In late 2019, the FDA introduced a new Safety and Performance Based Pathway which can potentially speed up the preparation and review process for certain submitters of pre-market notification medical device submissions. This optional pathway was created by the FDA to assist with well understood device types, in which a submitter references device specific guidance’s detailing the appropriate testing standards,

Tagged : 510(k), catheters, coils, contact lenses, cutaneous, device, eCopy, electrodes, FDA, foley, Guidance, industry, magnetic, medical, orthopedic, pathway, performance, plating, regulators, safety, screws, spinal, submission, washers

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Tag: submission

New premarket submission route: FDA’s eSTAR Program from pilot to production by Oct 1, 2023

New Medical Device Pathway: Safety and Performance Based Pathway