Emergo Group, a worldwide medical device regulatory compliance firm, says the Food and Drug Administration’s (FDA) more rigorous – and more frequent – inspections during the Obama administration have resulted in the uptick in citations.
The inspections hit a seven-year low in 2008 – with 1,423 investigations – and have increased ever since, reaching 2,121 by 2011 and dipping slightly last year to just more than 2,000.
“Medical device firms should expect the trend of stepped-up FDA inspections to continue through the Obama administration's second term,” writes Emergo Group in the report.
The FDA annually inspects medical device manufacturers to “ensure they comply with medical device safety and effectiveness regulations,” according to the website. The warning letters are one way to alert the companies about violations in regulatory codes and are posted on its website.
When given a warning letter, the firms are expected to write back to the regulator with how it plans on how to fix the compliance issues.
Most of the letters sent to companies last year had to do with quality control issues, according to the firm’s review.