Recently, the FDA issued a final rule to amend regulations on medical device premarket submissions to remove requirements for paper and multiple copies. Instead, sponsors will submit a single submission in electronic format. Because a medical device premarket submission in electronic format is easily reproducible, the requirement for multiple copies, whether in electronic format or paper form, is no longer necessary. The rule is effective as of January 15, 2020.
The rule affects a variety of submission types including:
- Premarket Notification (510(k)) submissions (21 CFR 807.90)
- Confidentiality of Information Certifications (21 CFR 807.95)
- Investigational Device Exemption (IDE) applications (21 CFR 812.20)
- Premarket Approval Applications (PMAs) (21 CFR 814.20)
- PMA supplements (21 CFR 814.39)
- Humanitarian Device Exemption (HDE) Applications (21 CFR 814.104)
These regulations cover both the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) regulated devices.
FDA believes it is beneficial to the public to limit any burden and expense to submitters caused by requiring additional copies. However, in order to achieve these benefits, sponsors will need an efficient process for producing eCopy submissions to the FDA.
“We estimate that the final rule will result in annualized benefits of $1.76 million at a 3 percent discount rate and $1.76 million at a 7 percent discount rate, over 10 years. We also estimate that the final rule will result in annualized costs of $0.75 million at a 3 percent discount rate and $0.87 million at a 7 percent discount rate, over 10 years.”
FDA
Ennov’s Dossier solution is a cost-effective solution for producing eCopy submissions. This web-based solution automates the production of eCopy by:
- Building eCopy submissions including the table of contents
- Enforcing validation rules to eliminate common mistakes
- Managing hyperlinks within the eCopy submission
- Adding documents by drag and drop from Ennov Doc
- Managing document updates to ensure that the eCopy dossier has the right versions of documents
Ennov Dossier also supports eCTD, paper CTD, NeeS, and VNees formats. Contact us to learn more about how Ennov can support your publishing needs.