Everyone Agrees the FDA 510(k) Process Needs to be Fixed

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Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Both sides played it pretty nice at yesterday’s press conference unveiling a new study analyzing the FDA’s 510(k) review process, but there’s a tension underneath it all: Industry generally thinks the FDA is way too slow and inconsistent in its 510(k) review process and threatens medical device innovation in the US, and FDA seems to agree that the review process needs some tinkering but isn’t so bad and that much of the problem lay with industry anyway.

While he thanked the Institute for Health Technology (InHealth) for conducting the survey and putting together this forum, FDA Director of CDRH Jeffrey Shuren cautioned that its findings should not be accepted without putting them in some perspective. He noted that the survey was only answered by about 10% of industry, and that those respondents were those who tended to have more complicated than average 510(k) situations.

That said, Shuren acknowledged that CDRH has to do a better job preventing high levels of employee turnover. InHealth’s survey found that one of six or seven reviewers left during the 510(k) review process they were working on, which clearly slows the process and makes life more difficult for medical device companies, especially smaller ones.

Shuren also said FDA and CDRH should and will produce more guidances and will work to address consistency issues. He also said that CDRH should do a better job of identifying those 510(k) applications that won’t be approved as early in the process as possible, therefore spending less time on those.

But Shuren also noted that industry, especially smaller device companies, isn’t doing such a hot job on its 510(k) submissions. For example, a recent FDA study found that about half of all submissions arrived at the agency missing key information out of the gate. He also challenged companies, again especially smaller ones, to take more advantage of pre-submission meeting opportunities with FDA.

The survey is part of “A Comprehensive Analysis of the FDA 510(k) Process: Industry Practice and the Implications for Reform,” a study funded by the Institute for Health Technolog (InHealth), a nonprofit foundation that supports research and analysis into the role of medical technology in advancing healthcare and patient quality of life. Bottom-line, it found that the vast majority of respondents (68%) say it is critically important that the regulatory process be predictable, and that 85% said they’d seen “substantive changes” from FDA in its 510(k) review process in the past three years.

The survey offered a number of recommendations it said would improve the process:

Enhance predictability

  • Increase number of guidance documents
  • Timely update of guidance documents
  • Clear and timely communication of new FDA expectations before publication in guidance

Increase process consistency

  • Increase training (particularly implementation of current regulations)
  • Reduce perceived differences in agency follow-through (by enhanced communication)
  • Reduce reviewer turnover

Ensure efficient review process

  • Preparation of clear and complete submissions
  • Eliminate repeat requests of information already provided
  • Timely access to meetings
  • Increased use of interactive review concept

Close gap with international systems

  • Continued harmonization efforts (GHTF)
  • Sharing best practices (particularly on process side), while acknowledging differences in regulatory requirements

Increase attention to specific needs of small companies (while maintaining a level playing field)

  • Improve opportunities for interaction
  • Provide training support in areas where small companies tend to face particular challenges

Monitor effect of process changes

  • Evaluate impact of any process changes through appropriate performance metrics
  • Work with industry to monitor process performance over time

It appears that FDA and industry agree that the 510(k) process is broken. But things get more complicated when they begin to discuss how badly its broken, and what’s needed to fix it.



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