Introduction
Following is a breakdown of 510(k) exempt and Good Manufacturing Practice (GMP)/Quality System exemptions listed by device class. All devices in this list are 510(k) exempt unless further qualified by a footnote. Only devices annotated by (*) are also exempt from GMP except for general recordkeeping requirements and compliant files.
Class I Devices
FDA has exempted almost all class I devices (with the exception of Reserved Devices from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. Some 510(k) exemptions annotated with "\#\" are with certain limitations as noted in the footnotes. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR xxx.9, where xxx refers to Parts 862-892.
If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and FDA clearance is not required before marketing the device in the U.S. However, these manufacturers are required to register their establishment by submitting Form FDA 2891, "Initial Registration of Device Establishment," and list the generic category or classification name of the device by submitting Form FDA 2892, "Device Listing."
IMPORTANT NOTE: Only the class I devices with an asterisk (*) are also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile.
Class II Devices
The Food and Drug Administration (FDA) has also published a list of class II (special controls) devices (those devices are annotated as "(II)"), subject to certain limitations, that are now exempt from the premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet a requirement of the Modernization Act. Class II devices are annotated "(II)". Please note that class II devices are NOT exempt from GMP requirements.
Footnotes:
| 5 |
Exemption is limited to air-conduction hearing aids. |
| 17 |
510(k) exempt if the teething ring does not contain a fluid. |
| 18 |
Only chairs without operative unit device are 510(k) exempt.
Dental chair with operative unit, product code KLC, requires 510(k) clearance.
Dental chair without operative unit, product code NRU, is exempt from 510(k). |
| 19 |
Only accessories are 510(k) exempt. |
| 20 |
510(k) exempt only if the device is made of inert materials and is not coated or impregnated with chemicals intended to provide a therapeutic benefit or interact with tissues of the oral cavity. |
| 21 |
Only the accessories tray to the unit is 510(k) exempt.
Dental operative unit, product code EIA, requires 510(k) clearance.
Oral cavity evacuator, product code EHZ , is exempt from 510(k).
Saliva ejector mouthpiece, product code DYN , is exempt from 510(k).
Suction operatory unit, product code EBR, is exempt from 510(k).
Operative dental unit accessories, product code NRD, is exempt from 510(k). |
| 88 |
If the device does not meet the following special control guidance, a 510(k) is required. ``Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations; Guidance for Industry and FDA.'' |
| 90 |
Reprocessed diamond-coated bur, product code NME, requires 510(k) clearance. |
| 91 |
Prescription denture cleanser, product code NUX, requires 510(k) clearance. An Rx denture cleanser is an effervescent tablet
for the removal of micro-organisms from removable dentures and retainers.
Over the counter denture cleanser, product code EFT, is 510(k) exempt. |
| 92 |
Reprocessed diamond dental instrument, product code NLD, requires 510(k) clearance.
Diamond dental instrument, product code DZP, is 510(k) exempt. |
| 93 |
If the device is made of the same materials that were used in the device before May 28, 1976, it is exempt from the
premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in ยง872.9.
The following three product codes associated with this regulation require 510(k) clearance. There are 59 product codes
associated with this regulation that are exempt from 510(k).
Dental lapping tool kit, product code NYG, requires 510(k) clearance.
Parallelometer, product code EGI, requires 510(k) clearance.
(Dental) irrigating syringe, product code EIB, requires 510(k) clearance. |
| 94 |
Reprocessed dental needle, product code NMW, requires 510(k) clearance.
Dental needle, product code DZM, is exempt from 510(k).
|
| 95 |
Reprocessed orthodontic metal bracket, product code NQS, requires 510(k) clearance.
Product codes ECI, DYO, ECM, EJF, ECN, DYJ, ECO, DZD, DZC, are exempt from 510(k). |
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