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Reminder! 5 May 2018 is the date for DMF (Drug Master File) and IND (Investigational New Drug) applications to comply with eCTD format submission. There has been a delay for Type III DMF files to comply. The FDA announced in April via their Guidance Document Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications that Type III DMF files will have until 5 May 2019 in order to comply with the eCTD format requirements. With the exception of Type III DMFs, all files not submitted in eCTD beginning 5 May 2018 will be rejected. Please see the FDA Drug Master File Tip Sheet for further information. If you have any questions, please do not hesitate to contact EAS.

We would like to bring to your attention the FDA draft Guidance Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria. Please note, comments on this draft are due to the FDA no later than 90 days after publication in the Federal Register(which was 12 April 2018). This draft guidance proposes to provide an optional pathway for certain well-understood device types which the FDA would identify on a list maintained on the FDA website. Rather than a direct comparison to the predicate device for a 510(k) submission, the FDA proposes to provide alternate objective performance criteria that would satisfy demonstrating substantial equivalence for performance relevant to safety and effectiveness. This will comply with the new congressional amendment to the FD & C Act for the “least burdensome” provisions for medical devices.

Guidance Document updates on the FDA website: CDER:






Posted in Drug and Device Corner, Drugs, Medical Devices.