Medtronic Inc. (Medtronic) said a decades-old review by the Food and Drug Administration (FDA) of certain medical devices likely won't affect the company's sales. On April 8, 2009 FDA asked companies to submit data on devices, marketed prior to 1976, such as certain spine products and pacemaker components, the year the agency was given authority to review new medical devices. The FDA approved these devices with minimal testing.
The FDA was supposed to assess these products and decide whether they needed extensive testing. The agency’s work on the matter dragged on and the Government Accountability Office criticized the agency in January 2009 for taking in excess of 30 years to complete the review.
The devices in question fall into 25 categories, and since new devices are often based off old ones, some products approved as recently as previous month may need to undergo an FDA review.
Medtronic spokesman Chuck Grothaus said the firm plans on submitting data to the agency about its devices. The company is still determining which devices it will need to submit data on, but Grothaus said Medtronic doesn’t “foresee” any sales impact.
Grothaus said the company has in some cases 30 years of evidence to prove the devices are properly classified under the FDA’s guidelines and are safe and effective.
Companies have 120 days to submit data to FDA for review. The agency will then review the products and categorize them on a three-point scale. Devices classified as Class III may pose the most trouble to companies.
Class III devices, such as pacemakers, pose the most risk to consumers and require broad testing before they reach the market. The FDA generally allows low- and moderate-risk devices, such as powered wheel chairs and tongue depressors, to go to market without extensive human clinical trials.
If the agency determines the devices reviewed are Class III, companies have several options. They can submit clinical data, which they may or may not have, and hope it passes the FDA’s approval standards. Or they can withdraw the product from the market or keep selling it and face legal troubles from the government.
Grothaus said “in most cases” Medtronic has the necessary data for its devices but noted that pulling a product from the market is always an option. He said the company is “confident” its devices are safe and effective.
Another risk to companies is that components from older devices may be on newer devices, which means any concerns about the old product may call into question the safety of the newer product.
Grothaus said it’s “unlikely” that this will be a problem for Medtronic, though he added the company will know more once it identifies what products it needs to submit data for.