Dive Brief:

• FDA released draft guidance Wednesday on the submission of medical device filings in an electronic format.

• In the draft text, FDA lists 510(k) filings, premarket approval applications and investigational device exemption submissions among the regulatory requests that will need to be processed electronically once the rules come into force.

• The draft is the precursor to a series of documents that will detail the submission formats and implementation timelines for specific types of regulatory applications.

Dive Insight:

The FDA Reauthorization Act of 2017 and MDUFA IV commitment letter require FDA to transition to electronic formats for medical device applications. One requirement of the documents is for FDA to create draft guidance on the topic by the start of October. The draft issued this week is intended to fulfill that requirement, although it is the start, not the end, of the process.  

FDA opted against creating a single guidance document covering electronic formats for all the filings, arguing it is not feasible to address everything in one text. Instead, FDA has published a general draft and plans to follow up with documents that address the specifics of each type of filing.

The general draft guidance lists the types of filings that will ultimately need to be sent electronically and states that compassionate use requests and adverse event reports are exempt from rules. FDA is encouraging organizations that file these types of requests or reports to do so electronically, but will not make the format mandatory.   

FDA has deferred establishing a position on many other key questions. The agency will discuss the criteria for waiving the requirement to submit electronically in the guidance documents on specific types of filing. FDA will also establish timelines for implementation in those specific documents.

The rest of the general draft guidance covers the process FDA will follow for the specific documents, which it plans to release for consultation.

After finalizing a document in light of feedback, FDA will publish it and set a date on which the use of the electronic format will become mandatory. If FDA revises the texts, it will give companies time to adapt to the changes. 

FDA said it will accept feedback on the document for 60 days from publishing.