FDA Weighing Future of Third-Party Device Review

Third-party outsourcing of <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">medical device approval is under review, the Wall Street Journal is reporting. Apparently, medical device makers—the Journal cited Philips Electronics NV, Siemens AG, and General Electric Co., for example—do not necessarily need to start the approval process with the U.S. Food and Drug Administration (FDA) and can have third-party companies handle such reviews. These reviews are then typically approved by FDA officials, the Journal noted.

This fast-tracking has been met with great criticism, and the agency is considering putting an end to the process, citing review quality and the original purpose for these types of reviews, said the Journal, which was to save taxpaying Americans money.

An FDA official, speaking at a meeting late last year regarding device approvals, said the “real value to industry may be that this is perceived as a way to ‘sneak things,'” quoted the Journal, citing minutes it reviewed from that meeting. It seems, said the Journal, that some third-party reviewers market a speedier, friendlier process. For instance, the Web site for third-party company, Citech Inc., boasts it can move a product to market “months sooner,” saying that its “third-party review is also friendlier, less adversarial, than FDA review,” quoted the Journal.

Earlier last year we wrote that many critics of the FDA had long complained of safety problems, corruption, conflicts of interest, and budgeting and system problems that appeared to be routine at the agency under the former administration. With the Obama administration, new leaders were put in place and safety became an issue of importance at the FDA. Now, the agency is looking at how to better evaluate medical devices, especially in light of an array of issues with recalled and defective medical devices, said Reuters previously. Critics argue the third-party review process is overused and allows for problems following approval, while industry is concerned about increased review times and costs, said Reuters.

The Journal wrote that one-third, even more, of the devices involved in the program include X-ray and MRI machines and that the program enables these device makers to speed up the release process by about one month. Some 300 such devices received third-party approval in the year ending September 30, 2008; 185 reviews took place five years prior. Citing FDA information, it accepted over 80 percent of all third-party reviews for radiological devices over the past ten years with no additional action taken, said the Journal.

The FDA is also considering limiting the devices this program covers or providing the third-party reviewers with additional information on devices to better assist them, said the Journal. Citing minutes and agency interviews, Jeffrey Shuren, the device division director at the FDA, said the agency will release its proposal later this year.

We recently wrote that, not surprisingly, industry, consultants to industry, and investors argued against major changes saying that such changes could hamper innovation and emerging technology, said Reuters. Meanwhile, the minutes of the December 2009 meeting also said, wrote the Journal, that “third parties often don’t have appropriate expertise,” citing “poor quality of review documents—they often just repeat what is in the submission, and don’t provide any analysis of the data.”

This entry was posted in Defective Medical Devices. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.