The United States Food and Drug Administration (USFDA), to enhance the submission process for medical devices, has introduced a final rule to replace the paper submissions with electronic submissions. The rule which was proposed in September 2018 is expected to come into effect in 2020. The final rule is aimed at improving the device's premarket submission program and targeted towards making the medical device submission process more efficient.

Submissions Required in Electronic Format

The criteria for electronic format extend to all forms of device submissions falling within the requirements of section 745A(b)(3) of the FD&C Act. Some of them include:

  • 510(k) submissions – Premarket notification submission
  • Evaluation of De Novo under 513(f)(2) for automatic class III designation request
  • Premarket approval applications (PMAs) including transitional PMAs as per 515(c) and 515(d)
  • Modular PMAs as per 515(d)(4)
  • Product development protocols (PDPs) under section 515(f)
  • Investigational device exemption (IDE) including the original IDEs, IDE Reports, IDE Supplements and Amendments
  • Humanitarian device exemption (HDE) as per section 520(m)
  • Emergency Use Authorizations (EUAs)

FDA may also identify and recommend electronic submission formats for the following:

  • Master Access Files (MAFs)
  • 513(g) Requests for Information (513(g)s)
  • Clinical Laboratory Improvement Amendments of 1988

Submissions Exempted from the Electronic Format

FDA has also established certain criteria for exceptions from the electronic format submission. The following forms of IDE submissions will be exempted from section 745A(b)(3) requirements:

  • Adverse event reports
  • Compassionate use requests

The final rule of electronic submissions for devices intends to increase cost savings without putting new Regulatory burdens on submissions and also reduces submission evaluation and review timelines for authority. 

To conclude, the FDA intends to finalize single electronic submission for medical devices only to overcome the multiple submissions and paper copies. The rule is expected to come into force from January 15, 2020. Thus, device manufacturers entering the U.S. market are required to comply with the new rules and binding and non-binding provisions. Stay updated. Stay compliant.


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