Reducing the complexity of Regulatory submissions, the global Regulatory Authorities transformed all the submissions from paper to electronic format. Respectively, there are several electronic submission formats proposed by country-specific Regulatory bodies.
Recently, the US FDA issued a new guidance for electronic submission for medical devices, following a draft guidance issued in September 2019. Delineating FDA’s strategies, this new guidance concludes that it is not feasible to describe and implement the electronic formats that would apply to all submissions covered under the statutory requirements of section 745A(b)(3) of the FDA Reauthorization Act of 2017 (FDARA), in one guidance document. Accordingly, FDA interprets the requirements of section 745A(b)(3), which specify the following:
- Submission types must be submitted electronically
- Timetable and process for implementing the requirements
- Criteria for waivers and exemptions from the submissions
Electronic Format Submissions: Submissions solely in electronic format in accordance with section 745A(b)(3) of the FD&C Act, include:
- Pre-market notification submissions (510k submissions)
- De Novo submissions
- Pre-market Approval Applications (PMAs), including, transitional and modular PMAs
- Product development protocols
- Investigational Device Exemption (IDE) applications of all types; humanitarian device exemptions, Emergency Use Authorizations (EUAs)
- Certain Investigational New Drug (IND) applications such as, those intended for use in screening donor blood
- Biological License Applications (BLAs) regulated by CBER as biological products, regardless of whether an IND submission is required before the BLA submission
- All Q-submissions to facilitate efficient review
FDA also clarifies that all subsequent submissions to an original submission must be submitted electronically. Irrespective of a single-page submission or a multi-volume submission, all the proposed requirements are applicable for electronic submissions. Any submission that does not meet the electronic format defined in the guidance will not be filed or received, unless it has been exempted from the electronic submission requirements or if there are waivers with respect to that submission.
Exemptions from Electronic Format Submissions: FDA claims to exempt the following types of IDE submissions:
- Expanded access compassionate use requests
- Emergency use reports
- Adverse event reports
Though there are exemptions for the above categories, FDA encourages electronic format submissions, as submission templates become available, to facilitate the review process. Also, Master Access Files (MAFs), 513(g) Requests for Information, and Clinical Laboratory Improvement Amendments of 1988 (CLIA) categorization requests and waiver applications do not require electronic submission. But FDA identifies and recommends voluntary electronic submission, as submission templates become available.
FDA intends to develop individual draft guidance documents to specify the electronic formats, subject matter, and scope of applicability for submissions under section 745A(b). To allow an eventually phased implementation, these guidance documents are released sequentially. The timelines required for electronic submissions of each submission type will be specified in the upcoming individual guidance.
Henceforth, medical device manufacturers willing to step-in the U.S. market should comply with the aforementioned new eSubmission formats, to reduce review timelines and submission evaluation process. Prepare compliant eSubmission documents with the right Regulatory expertise. Stay safe. Stay informed. Stay compliant.