The Advanced Medical Technology Assn. said it is “generally pleased” with what it saw from the Food & Drug Administration’s proposed plan to re-vamp the process by which a majority of medical devices are cleared for market but warned that the proof is in the pudding.
The Washington D.C. based industry council told reporters during a conference call that while it believes the 510(k) process is fundamentally sound, its slower pace, especially when compared to other country’s regulatory systems harm innovation and patient access to new technologies.Therefore the council said it will turn its attention to the pace at which the 25 announced changes are implemented.
The modifications are a step in the right direction and “generally adheres to our principal that changes should be targeted, have a corresponding health benefit and support timely access treatments and cures,” AdvaMed senior executive vice president David Nexon said during the call.
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But Nexon warned that those steps are only the first part of what he called a “very complicated set of implementation steps”.
The FDA plans to roll out its new plan through a process of guidance documents and proposals for new rules, both of which will be open to public comment while in development.
There will be at least eight guidance documents that the agency needs to put out over the coming year, according to Nexon, and how those come out “will make a big difference in whether the FDA continues to move in the right direction,” he said.
Nexon said many of the proposals released yesterday have the potential to improve the timeliness and consistency of the review process such as enhancing reviewer training, involving external scientific experts, improving the consistency of reviews by developing device-specific guidance documents and streamlining the de novo process for medical devices without a predicate.
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“I think that the FDA was pretty exhaustive in its proposals that it put forward for consideration and what they’re doing in terms of the implementation plan,” he said.
Click here (PDF) to download a schedule for the FDA’s changes to the 510(k) process.
The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
