Originally Published MDDI January 2005
CDRH has not come as far as some other FDA centers in achieving the ability to handle electronic submissions. Nonetheless, some progress is being made. Thus, device companies should stay abreast of the center's capabilities and take advantage of them at the appropriate times, industry and FDA experts said at a session of the RAPS annual meeting.
"True electronic submissions in the premarket area is a concept that is well in the future," said Mitchell Shein, a senior cardiovascular devices reviewer at CDRH's Office of Device Evaluation. "We are still building an infrastructure. But we are getting there in other areas."
FDA reviewers are interested in electronic submissions because they enable reviewers to do automated searching, work on a review from different locations, and build review memos easily, he said. Not being able to lose pages is a bonus as well.
One significant project is the e510(k) initiative, for which CDRH is developing an application template for 510(k)s. "The long-term goal is to implement [electronic submissions] that can automatically populate a review memo with administrative and descriptive elements, freeing reviewers to focus on analysis and recommendations," Shein said. "In the first or second quarter of 2005, we expect to roll out a pilot program."
Other areas where CDRH has made progress with electronic submissions include the Office of In Vitro Diagnostics and in radiological health, he said.
Given CDRH's enthusiasm for electronic submissions, firms should set a strategy for how they will be handled in the future, said Marlene Peterson, regulatory manager at Medtronic Inc. (Minneapolis).
"It is imperative that you have upper-management support," she said. "Standardize templates and processes, develop strategies for user resistance, and keep abreast of regulatory initiatives."
She noted her firm has faced a number of challenges so far, including having source documents not readily attainable because they are stored in different locations, and not having standard cross-functional compatible templates or style guides.
While a large firm such as Medtronic is building a complex, multifunctional system to address the issue, smaller manufacturers should be able to go electronic by using "simple tools such as Adobe Acrobat," she said.
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