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CDRH Says It has Improved Its Processes. Do you Agree?


Posted in Regulatory and Compliance by Heather Thompson on January 25, 2013

The agency is touting its medical device review record as it plans for 2013.

 

Has CDRH turned the corner? The center has been publicly battered in recent years for allegedly letting undeserving medical devices onto the market and is still facing litigation from former employees who blew the whistle on its sins. Nonetheless, CDRH closed out 2012 by issuing glowing, full-color reports touting its record of product reviews and promoting its mission to protect the public. 

The first, “Improvements in Device Review,” is 24 pages long, including references. It contends that in the two years since the center announced its action plan, “the speed and predictability of device review have improved for the first time in almost a decade, including significant reductions in the time it takes FDA to review applications and the size of application backlogs.” 

Better than glossy reports is more meaningful transparency from the center.

CDRH rounded the numbers up when it comes to the time frame in that statement. First, the “almost a decade” is really eight years (the benchmark year is 2005). Further, the period of improvement is likely somewhat short of two years because the report says it “began” happening in 2011 but doesn’t say precisely when.

Management’s eagerness to polish the center’s public image through Web-based, one-way communication channels is understandable. Unverifiable reports say there is low internal morale stemming from the public abuse from Congress and the media generated by whistleblower complaints dating back to 2005. But exaggerating achievements with fuzzy numbers—if that’s what’s going on—is an unnecessary tactic.

Overlooking the shaky timeline, this report tells us CDRH’s 510(k) backlog has dropped by almost two-thirds since 2010, and PMA decision times have been reduced by about one-third. Further, the percentage of submitted 510(k)s cleared and PMAs approved has also increased.

The report says these results have been achieved even though its revamp plan is not yet fully implemented. The center expects review times and reductions in backlogs to continue to improve, particularly because the recently renewed user fee program includes additional enhancements.

For six consecutive years, the percentage of 510(k) substantial equivalence (SE) determinations “steadily decreased,” reaching a low of 73% in 2010,  according to the report. “In 2011, SE determinations rose to 78% and in 2012, SE determinations rose to 80%,” it says. “This has occurred without any decrease in the standards for clearance, suggesting that the increase may be due to better quality 510(k) submissions and more consistent decision making.”

The percentage of 510(k)s for which CDRH requested additional information from the manufacturer during the first review cycle has begun to decrease, the report says. From 2002 through 2010, more information requests were issued, caused by increasing device complexity, mid-stream changes in data requirements, and poor-quality applications, the center says. Its revamp plan “addresses each of those problems and the number of requests for additional information has now begun to decrease,” it says.

The center said in conclusion that its plan of action “has successfully increased the predictability, consistency, transparency, efficiency, and timeliness of premarket review.” Further, the report notes, “Over the previous decade, important indicators of the efficiency of the FDA’s device review program, including the average length of review and the size of the backlog of overdue applications, had steadily worsened. Since the FDA began implementing the Plan, almost every major indicator has reversed and is now pointing in the right direction for the first time in many years.”

Better than glossy reports is more meaningful transparency from the center. The second CDRH publication released is its “2013 Strategic Priorities.” That report, at least, features hard action dates for the center’s targeted accomplishments this year. The 12-page document lists six priorities:

  • To ensure U.S. patients have access to high-quality, safe, and effective medical devices of public health importance first in the world.
  • To ensure the U.S. is the world’s leader in regulatory science, medical device innovation and manufacturing, and radiation-emitting product safety.
  • To make sure U.S. postmarket surveillance quickly identifies poorly performing devices, accurately characterizes real-world performance, and facilitates device approval or clearance.
  • To make sure devices are legally marketed in the United States and remain safe, effective, and of high quality.
  • To ensure consumers, patients, their caregivers, and providers have access to understandable science-based information about medical devices and use this information to make healthcare decisions.
  • To strengthen the CDRH workforce and workplace.

The priorities have hard action dates, an example of the center sticking its neck out. For example, under Priority 1, the document says that in 2013, CDRH will continue to strengthen its premarket review plan of action. By March 31, the center will improve management of premarket review content and processes by incorporating commercial technologies and standardized information management practices. By August 31, CDRH will collect public input on deciding when to submit a 510(k) for a change to an existing device (i.e., 510(k) modifications). One exception is the guidance on deciding when to submit a 510(k) for a change to an existing medical device. By September 30, the center has said it will finalize all already issued draft guidance documents identified in the plan of action to strengthen premarket review. By December 31, CDRH will take steps to modernize the infrastructure and processes for the review of premarket applications. The December-31 deadline also marks the date in which CDRH will launch a pilot with industry for the electronic submission of 510(k)s.

Is it time to stop beating up on CDRH? Is the center as good as it says it is? I suspect the people who know best might not be able to discuss. 

 

More Washington Wrap-Up

FDA-Industry Consortium to Speed Device Reviews

CDRH Answers Slowness Critics on Patient Blog

 


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