On March 16, 2012, the U.S. Food and Drug Administration (“FDA”) announced its issuance of a proposed rule intended to lower the regulatory classification for nucleic acid-based tuberculosis tests. These tests, which are currently classified as Class III medical devices, are used in the detection of tuberculosis (“TB”) from a patient’s mucus (sputum) sample. With this classification downgrade, device sponsors will be able to bring devices to the market with both greater ease and less expense. In addition to the proposed rule, the FDA issued a draft guidance to aid in the transition from Class III to Class II.
The FDA regulates medical devices on a three-tier, risk-based approach. Class I devices, the lowest risk devices, generally do not require FDA clearance prior to marketing. However, these devices are still considered “regulated” by the Agency and device sponsors must comply with establishment registration and device listing requirements, among other regulations. More information about Class I devices may be found here. Class II devices, considered moderate-risk devices, largely require FDA clearance prior to marketing. Known as a premarket notification or “510(k) clearance” because of the statutory section necessitating this requirement, these devices must demonstrate substantial equivalence to previously cleared devices prior to being legally marketed. More information about the premarket notification process can be accessed here. Finally, Class III devices, or high-risk devices, are subject to the most stringent requirements, including the submission of a premarket approval application (“PMA”). Contrasted with the 510(k) clearance, the PMA process is more rigorous because it requires a device sponsor to demonstrate that its device is safe and effective for its intended use, based on scientific evidence. More information about the PMA process may be found here.
While the particular regulations accompanying each device class may be complicated, the professionals at the Law Office of Katherine Giannamore, P.A. are here to help. For more information about the FDA’s device classification scheme or assistance with marketing your device legally, contact us at contact@sglawfl.com.