By Stewart Eisenhart, Emergo Group
New guidance from the US Food and Drug Administration spells out how medical device manufacturers and study sponsors should format standardized study data for electronic submission.
The guidance pertains to submissions of clinical and non-clinical data related to Investigational Device Exemptions (IDEs), premarket notifications (510(k)s) and premarket approval applications (PMAs) submitted to the Center for Devices and Radiological Health, the Center for Biologics Evaluation and Research and other medical device and pharmaceutical review divisions of the FDA.
Planning and Provision of Standardized Data
First, study sponsors should include descriptions of their standardized study submission plans in their IDEs. These plans must also be included in the Data Management Plan sections of sponsors’ IDE study protocols, and lay out which data standards sponsors intend to use. (Any studies that will not be standardized should also be described, along with explanations for using non-standardized studies.)
Second, the guidance recommends that study sponsors utilize terminology standards such as CDRH Event Problem Codes as part of their standardized electronic submission efforts. This makes FDA analysis of study data more efficient. The FDA Study Data Standards Resources Web Page lists all terminology standards currently accepted by agency divisions.
Standardization of Previously Collected Nonstandard Data
In cases where study data elements cannot be readily converted to standardized formats, sponsors should document why such data could not be fully standardized. In addition, sponsors should identify which studies contain nonstandard data that were converted to standard formats.
Sponsors should also conduct data validation prior to sending their submissions to the FDA. The agency recognizes two major validation rules: technical validation rules to ensure data submitted conforms to standards, and business validation rules to ensure that data will support relevant business processes as intended.
Finally, the guidance recommends using FDA-sponsor meetings such as pre-IDE meetings to point out any outstanding study data standardization issues. In addition, sponsors and manufacturers can send technical questions at any time to CDRH and/or CBER technical support teams.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.