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U.S. Department of Health and Human Services

Medical Device Exemptions 510(k) and GMP Requirements

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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 and list the generic category or classification name. Registration and listing information is submitted by using FDA’s Unified Registration and Listing System (FURLS)/ Device Registration and Listing Module (DRLM) at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053185.htm

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.


PART 868 - ANESTHESIOLOGY DEVICES Show All Parts
868.1030 manual algesimeter.  *
868.1040 powered algesimeter. (II)  
868.1575 gas collection vessel.  
868.1870 gas volume calibrator.  
868.1910 esophageal stethoscope.  
868.1930 stethoscope head.  
868.1965 switching valve (ploss).  *
868.1975 water vapor analyzer.  
868.2300 bourdon gauge flowmeter.  
868.2320 uncompensated thorpe tube flowmeter.  
868.2340 compensated thorpe tube flowmeter.  
868.2350 gas calibration flowmeter.  
868.2385 nitrogen dioxide analyzer. (II)  
868.2500 cutaneous oxygen (pco2) monitor. (II)  
868.2550 pneumotachometer. (II)  
868.2610 gas pressure gauge.  
868.2620 gas pressure calibrator.  
868.2700 pressure regulator.  
868.2875 differential pressure transducer.  
868.2885 gas flow transducer.  
868.2900 gas pressure transducer.  
868.5100 nasopharyngeal airway.  
868.5110 oropharyngeal airway.  
868.5115 device to relieve acute upper airway obstruction. (II)  
868.5180 rocking bed. (II)  
868.5220 blow bottle.  *
868.5240 anesthesia breathing circuit.  
868.5280 breathing tube support.  
868.5300 carbon dioxide absorbent.  
868.5310 carbon dioxide absorber.  
868.5320 reservoir bag.  
868.5340 nasal oxygen cannula.  
868.5350 nasal oxygen catheter.  
868.5365 posture chair for cardiac or pulmonary treatment.  
868.5375 heat and moisture condenser (artificial nose).  
868.5420 ether hook.  *
868.5460 therapeutic humidifier for home use.  
868.5530 flexible laryngoscope.  
868.5540 rigid laryngoscope.  
868.5550 anesthetic gas mask.  
868.5560 gas mask head strap.  
868.5570 nonrebreathing mask.  
868.5580 oxygen mask.  
868.5590 scavenging mask.  
868.5600 venturi mask.  
868.5620 breathing mouthpiece.  
868.5640 medicinal nonventilatory nebulizer (atomizer).  
868.5675 rebreathing device.  
868.5700 nonpowered oxygen tent.  
868.5760 cuff spreader.  *
868.5770 tracheal tube fixation device.  
868.5780 tube introduction forceps.  
868.5790 tracheal tube stylet.  
868.5795 tracheal tube cleaning brush.  *
868.5810 airway connector.  
868.5820 dental protector.  
868.5860 pressure tubing and accessories.  
868.5975 ventilator tubing.  
868.5995 tee drain (water trap).  
868.6100 anesthetic cabinet, table, or tray.  
868.6175 cardiopulmonary emergency cart.  *
868.6225 nose clip.  *
868.6250 portable air compressor. (II)  
868.6400 calibration gas.  
868.6700 anesthesia stool.  
868.6810 tracheobronchial suction catheter. 81  
868.6820 patient position support.  
868.6885 medical gas yoke assembly.  




Footnotes:

81 Device is not exempt from the design control requirements section of the GMP.
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