On September 26, 2014, The United States Court of Appeals for the District of Columbia Circuit ruled that the FDA had “short circuited” its procedural requirements, pertaining to device reclassification and formal rulemaking, when it reevaluated a medical device being sold on the market in an effort to require the device to obtain further approval. The medical device that was the subject of the controversy was an absorbable surgical mesh, designed for use in knee replacement surgeries, called the Collagen Scaffold. In 2008, the device manufacturer obtained clearance from the FDA, through the 510(k) process, to market the Collagen Scaffold. After the device was cleared and being marketed in the United States, the FDA later attempted to rescind the clearance, amidst pressures arguing that the Agency improperly cleared the device. This rescission was given by notifying the Company that the clearance was “in error” and that the Company must seek approval under the Premarket Approval (“PMA”) process. The FDA then issued an order, which rescinded its original decision clearing the Collagen Scaffold through substantial equivalence and immediately took the product off the market.Ultimately, this resulted in what the Court considered to be an improper device reclassification.
The Court found that the FDA would have to utilize formal device reclassification procedures if the Agency wanted to make changes to the device’s status. Device reclassification, which is accomplished through the formal rulemaking process, removes a device from the market, requiring the device to go through the approval process before it can be marketed again. This process includes a notice and public comment period before the device reclassification is finalized and the device may be removed from the market. Accordingly, by finding that the FDA must actually reclassify a cleared device in order to have the authority to effectively change its previous determination, the Court found that the FDA had exceeded its authority in the present case. In addition, the Court struck down the FDA’s assertion that it had “inherent reconsideration authority” when reclassifying a device. The court’s holding reinforces the importance of the device reclassification procedures outlined in the Federal Food, Drug, and Cosmetic Act (“FFDCA”), which include notice and public comment through formal rulemaking.
The Federal Food, Drug, and Cosmetic Act mandates that the FDA classify medical devices into one (1) of three (3) categories, Class I, Class II, and Class III. Class I devices generally pose little to no risk and are subject to the least amount of regulatory controls. Class II devices are higher risk devices that require increased regulatory controls and typically must receive clearance prior to marketing. Class III devices are the highest risk devices and are subject to the strictest regulatory control; Class III devices must be approved by the FDA prior to being released to the market.
Generally, prior to marketing a Class II device, the device sponsor must utilize the Premarket Notification process, as prescribed in Section 510(k) of the FFDCA. For more information on Section 510(k) please visit our website. Failure to comply with Section 510(k) can result in serious consequences. For Class III devices, Premarket Approval, as distinguished from clearance, is required, unless it falls under the exemptions found in applicable FDA regulations.
With respect to device reclassification, the FDA must take very specific steps, as outlined in section 515 of the FFDCA, in order to properly reclassify a device. In particular, the FDA must do five (5) things before a device can be reclassified:
- Collect existing scientific information from scientific experts in the medical community and assess the risks and benefits of the medical device type subject to the device reclassification;
- Convene a meeting of the medical device advisory committee to request input on the device reclassification;
- Issue a proposed order reclassifying the device type into Class I, II or III;
- Review and consider comments submitted by the public, and
- Issue a final order reclassifying the device type into Class I, II or III.
If you are marketing a medical device, compliance with the FDA regulations is important. If you have any questions about compliance with FDA regulations, please contact us at firstname.lastname@example.org