Study: FDA Enforcement Growing for Medical Device Companies

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Turns out that some paranoid people have a reason to, well, be paranoid.

Researchers from the London Business School issued a report last year finding that many people at work who thought they were being talked about were probably right.

Maybe some in the medical device industry can be forgiven for thinking the FDA has come down harder on them in recent years.  A new study kind of backs their “paranoia,” too.

FDA efforts since 2009 to strengthen key policies has resulted in more medical device enforcement that will have a “long-lasting” effect on the industry, says an independent study from Greenleaf Health’s enforcement and compliance team. It was overseen by former FDA Associate Commissioner for Regulatory Affairs, Michael Chappell.

The Medical Device Enforcement Report focused on four specific area of medical device enforcement data: FDA inspections, 483s, warning letters and product recalls.

Medical Device Recalls

There is a general correlation between CDRH and FDA increasing recall numbers. In 2007, 1,279 medical device products were recalled – that number soared to 3,211 in 2011.

Here’s are some of the more telling stats:

  • Since 2005, CDRH inspections have accounted for 10 – 12% of all FDA inspections.
  • CDRH inspection numbers have increased at a rate consistent with FDA inspection numbers, the report sats. In 2005, CDRH inspected 2,304 facilities compared to 3,369 in 2011.
  • In 2008, CDRH issued 152 warning letters, compared to 200 in 2010.
  • In 2007, 1,279 medical device products were recalled – that number soared to 3,211 in 2011, according to data collected by Greenleaf.
  • Over the last five years, 483s issued to device manufacturers have accounted for 6% of all 483. The number of 483s issued by FDA – for all regulated products – has increased from less than 4,000 in 2008, to nearly 5,000 issued in 2010. The number of 483s issued for CDRH regulated products has remained steady over the 5-year period annually.

Greenleaf’s team suggests that these rising numbers can be attributed to a conscious FDA policy shift that includes more efficient review of warning letters, increased prosecution of misdemeanors, creation of the “Bad Ad” program, and the increased role and responsibility of FDA enforcement officials.

Here’s the $64,000 question: If you are paranoid that something bad is happening to you, and then you learn you may be right and not paranoid, is that a relief?

We’ll let those in the medical device industry speak for themselves on that one.

To purchase the full study, go to www.greenleafhealthllc.com

 

 

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Study: FDA Enforcement Growing for Medical Device Companies
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Study: FDA Enforcement Growing for Medical Device Companies
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FDA efforts since 2009 to strengthen key policies has resulted in more medical device enforcement that will have a "long-lasting" effect on the industry, says an independent study from Greenleaf Health's enforcement and compliance team.
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AssurX
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  • […] Are we dealing with a new FDA? I posed this question last summer. In the past couple years, CQ has had quite a few engagements to help medical device companies during FDA inspections and to correct FDA 483 and warning letter observations. Data also supports my anecdotal experience as reported in a recent post on the AssurX blog: […]

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