Electronic device submissions addressed in FDA guidance
A new final guidance from the US Food and Drug Administration (FDA) lays the framework for electronic submissions for medical devices. The agency advised that more specifics about the nuts and bolts of electronic submissions, as well as the timing of implemention, will be provided in upcoming guidances.One guidance document is insufficient for describing and implementing electronic formats for all types of submissions covered under the statutory requirements, said FDA in the newly issued guidance, which delineates the agency’s plans for implementing the requirements of section 745A(b)(3) of the FDA Reauthorization Act of 2017 (FDARA). The newly issued final guidance follows a draft guidance issued in September 2019. (RELATED: Electronic device submissions: FDA drafts guidance, Regulatory Focus, 25 September 2019)
The guidance does clarify the types of guidance that must be submitted electronically. These include premarket notification submissions (501k submissions); De Novo submissions; premarket approval applications (PMAs), including transitional and modular PMAs; product development protocols, investigational device exemption applications of all types; humanitarian device exemptions, Emergency Use Authorizations; and certain investigational new drug (IND) applications such as those intended for use in screening donor blood.
Also included are biological license applications (BLAs) regulated by CBER as biological products, regardless of whether an IND submission is required before the BLA submission. Though Q-submission types aside from pre-submissions are not required to be in electronic format, “FDA recommends that all Q-submissions be submitted in electronic format to facilitate efficient review,” according to the guidance.
Subsequent submissions to an original submission must also be submitted electronically if the original submission had to be in electronic format, even for single-page submissions, clarified the agency.
Some submissions are now exempted, or may be exempted in upcoming guidances, said FDA. Currently, expanded access compassionate use requests and emergency use reports, as well as adverse event reports are not required to be submitted electronically, though electronic submission is still encouraged to facilitate review.
Master Access Files, 513(g) requests for information, as well as Clinical laboratory Improvement Amendments of 1988 (CLIA) categorization requests and waiver applications, do not fall under the requirements for electronic submission, though voluntary electronic submission will become an option as templates are developed and issued, said FDA.
FDA will develop individual draft guidance documents “to specify the electronic formats, subject matter, and scope of applicability for submissions under section 745A(b),” with the intent of releasing the draft guidances sequentially in order to allow for phase implementation. The timeline for requiring electronic submissions will also be specified for each submission type in the upcoming individual guidances.