Medical Device Exemptions 510(k) and GMP Requirements

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: https://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 exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) or the 21st Century Cures Act of 2016 (Cures 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 requirements of FDAMA and the Cures Act. Class II devices are annotated "(II)". Please note that class II devices are NOT exempt from GMP requirements.

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PART 884 - OBSTETRICAL AND GYNECOLOGICAL DEVICES Show All Parts

884.1040	viscometer for cervical mucus.
884.1550	amniotic fluid sampler (amniocentesis tray).
884.1630	colposcope. (II)
884.1690	hysteroscope and accessories.
884.1700	hysteroscopic insufflator.
884.1720	gynecologic laparoscope and accessories.
884.1730	laparoscopic insufflator.
884.2900	fetal stethoscope.
884.2990	breast lesion documentation system. (II)
884.3200	cervical drain. (II)
884.4400	obstetric forceps. (II)
884.4520	obstetric-gynecologic general manual instrument.
884.4530	obstetric-gynecologic specialized manual instrument. (II)
884.4530	obstetric-gynecologic specialized manual instrument.
884.4900	obstetric table and accessories. (II)
884.5150	nonpowered breast pump.
884.5200	hemorrhoid prevention pressure wedge. (II)
884.5390	perineal heater. (II)
884.5400	menstrual cup. (II)
884.5425	scented or scented deodorized menstrual pad. (II)
884.5425	scented or scented deodorized menstrual pad.
884.5435	unscented menstrual pad.
884.5900	therapeutic vaginal douche apparatus.
884.5920	vaginal insufflator.
884.5960	genital vibrator for therapeutic use. (II)
884.6120	assisted reproduction accessories. (II)
884.6130	assisted reproduction microtools. (II)
884.6150	assisted reproduction micromanipulators and microinjectors. (II)
884.6160	assisted reproduction labware. (II)
884.6180	reproductive media and supplements. (II)
884.6190	assisted reproductive microscopes and microscope accessories.

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Footnotes:

46	New definition: The amniotic fluid sampler (amniocentesis tray) is a collection of devices used to aspirate amniotic fluid from the amniotic sac via a transabdominal approach. Components of the amniocenteses tray include a disposable 3 inch 20 gauge needle with stylet and a 30 cc. syringe, as well as the various sample collection accessories, such as vials, specimen containers, medium, drapes, etc. The device is used at 16­18 weeks gestation for antepartum diagnosis of certain congenital abnormalities or anytime after 24 weeks gestation when used to assess fetal maturity. [510(k) exempt]
47	Only culdoscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources are 510(K) exempt. Such culdoscope accessory instruments include: lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (non­inflatable) scissors, and suction/irrigation probe.
48	Only hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources are 510(k) exempt. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors.
49	Only tubing and tubing/filter fits which only include accessory instruments which are not used to effect intrauterine access, e.g. hysteroscopic introducer sheaths, etc.; and single­use tubing kits used for only intrauterine insufflation are 510(k) exempt.
50	Only gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources are 510(k) exempt. Such gynecologic laparoscope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe.
51	Only tubing and tubing/filter kits which include accessory instruments which are not used to effect intra­abdominal access, Verres needles etc.; and single­use tubing kits used for only intra­abdominal insufflation (pneumoperitoneum) are 510(k) exempt.
52	Only amniotome, uterine tenaculum, nonmetal, fiber optic vaginal speculum, umbilical clamp and cutter, uterine curette, cervical dilator (fixed­size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps are 510(k) exempt.
53	510(k) exempt only if the device is using either a bulb or telescoping mechanism which does not develop more than 250 mm Hg suction, and the device materials that contact breast or breast milk do not produce cytotoxicity, irritation, or sensitization effects.
54	510(k) exempt only if the device is operated by gravity feed.
80	510(k) exempt only when the device is made of common celluosic and synthetic material with an established safety profile.