EMERGO SUMMARY OF KEY POINTS:

• US FDA wants only electronic submissions for most medical device premarket applications.
• US regulators currently require both paper and electronic copies of 510(k) and other premarket submissions.
• FDA will accept both eCopy and eSubmission formats as qualified electronic submissions.

Medical device regulators at the US Food and Drug Administration intend to eliminate requirements for paper and multiple copies of premarket applications in favor of single electronic submissions for agency review.

The FDA’s new proposed rule would apply to the following premarket application types:

• 510(k) premarket notifications
• Investigational Device Exemptions (IDE)
• Premarket Approvals (PMA) applications and supplements
• Humanitarian Device Exemptions (HDE)
• Applications to the Center for Biologics Evaluation and Research (CBER)

Qualified FDA electronic submission formats

FDA provides clear information on what the agency considers “electronic format” for premarket submissions. FDA will consider both eCopy submissions provided via CD, DVD or USB and mailed to the agency, and eSubmissions, submitted via the Internet, as qualified electronic submissions.

The proposed rule will go into effect 30 days following publication of its final version in the US Federal Register.

Related US FDA medical device regulatory information from Emergo:

• US FDA 510(k) registration consulting for medical device and IVD companies
• FDA submission consulting for medical devices and IVDs
• Whitepaper: Preparing a US FDA 510(k) submission
• Video overview: The US FDA medical device regulatory process