U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health
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This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
This document is intended to describe FDA’s intent with regard to enforcement of premarket notification (510(k)) requirements for certain in vitro diagnostic and radiology devices under 21 CFR Part 807, Subpart E. FDA intends to propose the downclassification and exemption from 510(k) requirements of the class II devices that are the subject of this guidance document because it believes the safety and effectiveness of these devices is sufficiently well established and they have sufficiently controlled risks that general controls are sufficient and a 510(k) review is not necessary to assure the safety and effectiveness of such devices, subject to the limitations to the exemption criteria found in 21 CFR 862.9, 21 CFR 864.9, 21 CFR 866.9, and 21 CFR 892.9. For the Class I devices that are the subject of this guidance document, FDA intends to propose an amendment to the classification regulations to exempt these devices from 510(k) requirements that currently apply under the reserved criteria of section 510(l) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), subject to the limitations on exemption criteria found in 21 CFR 862.9. See 65 FR 2296. In the interim period while FDA proposes and finalizes such downclassification and exemption, FDA intends to exercise enforcement discretion with regard to 510(k) submission requirements for the devices listed in this guidance.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
FDA has identified certain Class I and Class II in vitro diagnostic (IVD) and radiology devices that have established safety and effectiveness profiles and for which it believes 510(k) review is not necessary to assure safety and effectiveness. While FDA intends to exempt these devices from the 510(k) requirement through rulemaking that would reclassify the Class II devices and amend the classification regulations of the Class I devices, FDA no longer believes it is necessary to review premarket notification (510(k)) submissions for these devices before they enter the market and intends to exercise enforcement discretion for these devices concerning the 510(k) requirement. The devices identified in this guidance as subject to enforcement discretion with regard to premarket notification requirements, subject to the limitations to the exemption criteria found in 21 CFR 862.9, 21 CFR 864.9, 21 CFR 866.9, and 21 CFR 892.9, are listed in section D. FDA intends to continue to enforce all of the FD&C Act’s other requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and 21 CFR 809.10); good manufacturing practice requirements as set forth in the Quality System regulation (QS reg) (21 CFR Part 820); and Medical Device Reporting (MDR) requirements (21 CFR Part 803). This action is being taken as an interim measure in anticipation of a rule reclassifying identified Class II devices as Class I and exempting all of these devices from premarket review.
The goal of this document is to outline FDA’s enforcement policy with regard to premarket notification requirements for certain in vitro diagnostic and radiology devices listed below in section D, subject to the limitations to the exemption criteria found in 21 CFR 862.9, 21 CFR 864.9, 21 CFR 866.9, and 21 CFR 892.9.
The devices subject to enforcement discretion:
Clinical Chemistry Devices
Devices classified under 21 CFR 862.1410 Iron (non-heme) test system, which includes the following product codes:
CFM - Bathophenanthroline, Colorimetry, Iron (Non-Heme)
JIY - Photometric Method, Iron (Non-Heme)
JIZ - Atomic Absorption, Iron (Non-Heme)
JJA - Radio-Labeled Iron Method, Iron (Non-Heme)
Devices classified under 21 CFR 862.1415 Iron-binding capacity test system, which includes the following product codes:
JMO - Ferrozine (Colorimetric) Iron Binding Capacity
JQD - Resin, Ion-Exchange, Thioglycolic Acid, Colorimetry, Iron Binding Capacity
JQE - Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity
JQF - Bathophenanthroline, Iron Binding Capacity
JQG - Radiometric, Fe59, Iron Binding Capacity
Devices classified under 21 CFR 862.1580 Phosphorous (inorganic) test system, which includes the following product code:
CEO - Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Devices classified under 21 CFR 862.1775 Uric acid test system, which includes the following product codes:
CDH - Acid, Uric, Phosphotungstate Reduction
CDO - Acid, Uric, Uricase (U.V.)
JHA - Acid, Uric, Uricase (Gasometric)
JHC - Acid, Uric, Uricase (Oxygen Rate)
KNK - Acid, Uric, Uricase (Colorimetric)
LFQ - Acid, Uric, Acid Reduction Of Ferric Ion
Devices classified under 21 CFR 862.3050 Breath - alcohol test system, which includes the following product code:
DJZ - Devices, Breath Trapping, Alcohol
Devices classified under 21 CFR 862.3220 Carbon monoxide test system, which includes the following product codes: