mdi ConsultantsFDA announces milestone
a new development in the field of medical device reporting – eMDR!!
FDA is looking in good stead to increase the efficiency in its processes and is evident from this recent development about eMDR. The FDA’s Center for Devices and Radiological Health (CDRH) is pleased to announce the Electronic Medical Device Reporting (eMDR) Final Rule and associated guidance. The eMDR final rule requires device manufacturers and importers to submit mandatory medical device reports (MDRs) to the FDA electronically, rather than in paper form. Electronic submission of medical device reports expedites processing and reduces the burden of data entry on the FDA, manufacturers, and importers.
Clients should take immediate note of the FDA’s development about medical device reporting. We felt that you be excited to know about this development and hence the following article will provide you with an insight about what this development is all about.
Full implementation of this rule is expected to:
- Reduce industry’s time and costs associated with transcribing data from internal data management systems to paper and mailing the paper reports to the FDA;
- Reduce FDA’s transcription errors, time, and costs associated with receiving paper reports and transcribing data to electronic format for review and analysis;
- Expedite FDA’s access to safety information in a format that supports efficient and comprehensive data analysis and reviews; and,
- Enhance FDA’s ability to communicate information about suspected problems to the medical device industry, health care providers, consumers, and other government Agencies.
FDA’s standpoint about this rule so far:
The final rule is effective 18 months from the publication date.
FDA is in the process of planning future outreach efforts to support compliance with the rule.
Please stay tuned for details and we look forward to hearing from you as we work together towards full implementation of electronic medical device reporting.
Additional useful links regarding this rule:
Questions and Answers about eMDR – Electronic Medical Device Reporting – Guidance for Industry, User Facilities and FDA Staff
Medical Device Reporting: Electronic Submission Requirements
IEmail us at info@mdiconsultants.com to know more about 510(k) applications or regulations for mobile medical apps and Ref: eMDR.