[Federal Register Volume 82, Number 70 (Thursday, April 13, 2017)]
[Notices]
[Pages 17841-17844]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-07468]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1610]


Medical Devices; Exemptions From Premarket Notification: Class I 
Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has 
identified a list of class I devices that are now exempt from premarket 
notification requirements, subject to certain limitations. FDA is 
publishing this notice of that determination in accordance with 
procedures established by the 21st Century Cures Act. This notice 
represents FDA's final determination with respect to the class I 
devices included in this document. FDA's action will decrease 
regulatory burdens on the medical device industry and will eliminate 
private costs and expenditures required to comply with certain Federal 
regulation.

FOR FURTHER INFORMATION CONTACT: Bryce Bennett, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993, 301-348-1446, email: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Under section 513 of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 360c), FDA must classify devices into one of three 
regulatory classes: Class I, class II, or class III. FDA classification 
of a device is determined by the amount of regulation necessary to 
provide a reasonable assurance of safety and effectiveness. Under the 
Medical Device Amendments of 1976 (1976 amendments) (Pub. L. 94-295), 
and the Safe Medical Devices Act of 1990 (Pub. L. 101-629), devices are 
classified into class I (general controls) if there is information 
showing that the general controls of the FD&C Act are sufficient to 
assure safety and effectiveness; into class II (special controls), if 
general controls, by themselves, are insufficient to provide reasonable 
assurance of safety and effectiveness, but there is sufficient 
information to establish special controls to provide such assurance; 
and into class III (premarket approval), if there is insufficient 
information to support classifying a device into class I or class II 
and the device is a life sustaining or life supporting device, or is 
for a use which is of substantial importance in preventing impairment 
of human health, or presents a potential unreasonable risk of illness 
or injury.
    Most generic types of devices that were on the market before the 
date of the 1976 amendments (May 28, 1976) (generally referred to as 
preamendments devices) have been classified by FDA under the procedures 
set forth in section

[[Page 17842]]

513(c) and (d) of the FD&C Act through the issuance of classification 
regulations into one of these three regulatory classes. Devices 
introduced into interstate commerce for the first time on or after May 
28, 1976 (generally referred to as postamendments devices), are 
classified through the premarket notification process under section 
510(k) of the FD&C Act (21 U.S.C. 360(k)). Section 510(k) of the FD&C 
Act and the implementing regulations, part 807 of Title 21 of the Code 
of Federal Regulations (CFR), require persons who intend to market a 
new device to submit a premarket notification (510(k)) containing 
information that allows FDA to determine whether the new device is 
``substantially equivalent'' within the meaning of section 513(i) of 
the FD&C Act to a legally marketed device that does not require 
premarket approval.
    The 21st Century Cures Act (Pub. L. 114-255) was signed into law on 
December 13, 2016. Section 3054 of that Act amended section 510(l) of 
the FD&C Act. As amended, section 510(l)(2) of the FD&C Act requires 
FDA to identify through publication in the Federal Register, any type 
of class I device that the Agency determines no longer requires a 
report under section 510(k) of the FD&C Act to provide reasonable 
assurance of safety and effectiveness. FDA is required to publish this 
determination within 120 days of the date of enactment of the 21st 
Century Cures Act and at least once every 5 years thereafter, as FDA 
determines appropriate. Section 510(l)(2) further provides that upon 
the date of publication of the Agency's determination in the Federal 
Register, a 510(k) will no longer be required for these devices and the 
classification regulation applicable to each such type of device shall 
be deemed amended to incorporate such exemption. In a final action, FDA 
intends to amend the codified language for each listed classification 
regulation to reflect the final determination with respect to 510(k) 
exemption. FDA's action will decrease regulatory burdens on the medical 
device industry and will eliminate private costs and expenditures 
required to comply with certain Federal regulation. Specifically, 
regulated industry will no longer have to invest time and resources in 
510(k) submissions for certain class I devices, including preparation 
of documents and data for submission to FDA, payment of user fees 
associated with 510(k) submissions, and responding to questions and 
requests for additional information from FDA during 510(k) review.

II. Criteria for Exemption

    As stated previously, section 3054 of the 21st Century Cures Act 
amended section 510(l) of the FD&C Act. In doing so, the amendments 
reorganized section 510(l) into subsections 510(l)(1) and (2). As such, 
subsection 510(l)(1) provides that a class I device is exempt from the 
premarket notification requirements under section 510(k) of the FD&C 
Act, unless the device is intended for a use which is of substantial 
importance in preventing impairment of human health or it presents a 
potential unreasonable risk of illness or injury (hereafter ``reserved 
criteria''). Based on these reserved criteria, FDA has evaluated all 
class I devices to determine which device types should be exempt from 
premarket notification requirements. In developing the list of exempt 
devices, the Agency considered its experience in reviewing premarket 
notifications for these devices, focusing on the risk inherent with the 
device and the disease being treated or diagnosed (e.g., devices with 
rapidly evolving technology or expansions of intended uses). The Agency 
also considered the history of adverse event reports under the medical 
device reporting program for these devices, as well as their history of 
product recalls. Following these considerations, FDA reached the final 
determination that the devices listed in table 1 do not meet the 
reserved criteria in that they are not intended for a use that is of 
substantial importance in preventing impairment of human health or 
present a potential unreasonable risk of illness or injury.

III. Limitations on Exemptions

    FDA believes that the types of class I devices listed in this 
notice should be exempt from the premarket notification requirements 
found under section 510(k) of the FD&C Act. However, an exemption from 
the requirement of premarket notification does not mean that the device 
is exempt from any other statutory or regulatory requirements, unless 
such exemption is explicitly provided by order or regulation. FDA's 
determination that premarket notification is unnecessary to provide a 
reasonable assurance of safety and effectiveness for devices listed in 
this document is based, in part, on the assurance of safety and 
effectiveness that other regulatory controls, such as current good 
manufacturing practice requirements, provide.
    In addition to being subject to the general limitations to the 
exemptions found in 21 CFR 862.9, 864.9, 866.9, 872.9, 876.9, 878.9, 
880.9, 882.9, 884.9 and 886.9, FDA may also partially limit the 
exemption from premarket notification requirements to specific devices 
within a listed device type. In table 1, for example, FDA lists the 
exemption of the ataxiagraph device as 510(k) exempt, but limits the 
exemption to such devices that do not provide an interpretation or a 
clinical implication of the measurement. All other ataxiagraph devices 
are still subject to premarket notification requirements because FDA 
determined that premarket notification is necessary to provide a 
reasonable assurance of safety and effectiveness for these devices.

IV. List of Class I Devices

    FDA is identifying the following list of class I devices that no 
longer require premarket notification under section 510(k) of the FD&C 
Act, subject to the general limitations to the exemptions:

                        Table 1--Class I Devices
------------------------------------------------------------------------
                                                             Partial
                                             Product        exemption
    21 CFR section         Device type         code      limitation  (if
                                                           applicable)
------------------------------------------------------------------------
862.1410..............  Bathophenanthroli  CFM          ................
                         ne, Colorimetry,
                         Iron (Non-Heme).
862.1410..............  Photometric        JIY          ................
                         Method, Iron
                         (Non-Heme).
862.1410..............  Atomic             JIZ          ................
                         Absorption, Iron
                         (Non-Heme).
862.1410..............  Radio-Labeled      JJA          ................
                         Iron Method,
                         Iron (Non-Heme).
862.1415..............  Ferrozine          JMO          ................
                         (Colorimetric)
                         Iron Binding
                         Capacity.
862.1415..............  Resin, Ion-        JQD          ................
                         Exchange,
                         Thioglycolic
                         Acid,
                         Colorimetry,
                         Iron Binding
                         Capacity.
862.1415..............  Resin, Ion-        JQE          ................
                         Exchange,
                         Ascorbic Acid,
                         Colorimetry,
                         Iron Binding
                         Capacity.
862.1415..............  Bathophenanthroli  JQF          ................
                         ne, Iron Binding
                         Capacity.
862.1415..............  Radiometric,       JQG          ................
                         Fe59, Iron
                         Binding Capacity.

[[Page 17843]]

 
862.1580..............  Phosphomolybdate   CEO          ................
                         (Colorimetric),
                         Inorganic
                         Phosphorus.
862.1660..............  Electrolyte        JJR          ................
                         Controls
                         (Assayed and
                         Unassayed).
862.1660..............  Controls For       JJS          ................
                         Blood-Gases,
                         (Assayed and
                         Unassayed).
862.1660..............  Enzyme Controls    JJT          ................
                         (Assayed and
                         Unassayed).
862.1660..............  Urinalysis         JJW          ................
                         Controls
                         (Assayed and
                         Unassayed).
862.1660..............  Single             JJX          Exemption is
                         (Specified)                     limited to
                         Analyte Controls                controls not
                         (Assayed and                    intended for
                         Unassayed).                     use in donor
                                                         screening
                                                         tests.
862.1660..............  Multi-Analyte      JJY          Exemption is
                         Controls, All                   limited to
                         Kinds (Assayed).                controls not
                                                         intended for
                                                         use in donor
                                                         screening
                                                         tests.
862.1660..............  Tonometer          LCH          ................
                         (Calibration and
                         Q.C. of Blood-
                         Gas
                         Instruments),
                         Clinical.
862.1660..............  Kit, Serological,  MJX          Exemption is
                         Positive Control.               limited to
                                                         controls not
                                                         intended for
                                                         use in donor
                                                         screening
                                                         tests.
862.1660..............  Kit, Serological,  MJY          Exemption is
                         Negative Control.               limited to
                                                         controls not
                                                         intended for
                                                         use in donor
                                                         screening
                                                         tests.
862.1660..............  Kit, Direct        MJZ          Exemption is
                         Antigen,                        limited to
                         Positive Control.               controls not
                                                         intended for
                                                         use in donor
                                                         screening
                                                         tests.
862.1660..............  Kit, Direct        MKA          Exemption is
                         Antigen,                        limited to
                         Negative Control.               controls not
                                                         intended for
                                                         use in donor
                                                         screening
                                                         tests.
862.1775..............  Acid, Uric,        CDH          ................
                         Phosphotungstate
                         Reduction.
862.1775..............  Acid, Uric,        CDO          ................
                         Uricase (U.V.).
862.1775..............  Acid, Uric,        JHA          ................
                         Uricase
                         (Gasometric).
862.1775..............  Acid, Uric,        JHC          ................
                         Uricase (Oxygen
                         Rate).
862.1775..............  Acid, Uric, Acid   LFQ          ................
                         Reduction of
                         Ferric Ion.
862.3050..............  Devices, Breath    DJZ          ................
                         Trapping,
                         Alcohol.
862.3220..............  Spectral Absorb.   JKS          ................
                         Curve,
                         Oxyhemoglobin,
                         Carboxyhemoglobi
                         n, Carbon-
                         Monoxide.
862.3220..............  Gas                JKT          ................
                         Chromatograph,
                         Carbon-Monoxide.
862.3220..............  Enzyme             MKU          ................
                         Immunoassasy,
                         Nocotine and
                         Nicotine
                         Metabolites.
862.3240..............  Cholinesterase     DIG          ................
                         Test Paper.
862.3240..............  Colorimetry,       DIH          ................
                         Cholinesterase.
862.3240..............  Acetylcholine      DLI          ................
                         Chloride,
                         Specific Reagent
                         for Pseudo
                         Cholinesterase.
862.3240..............  Solution, M-       DMR          ................
                         Nitrophenol,
                         Specific Reagent
                         for
                         Cholinesterase.
862.3240..............  Electrometry,      DOH          ................
                         Cholinesterase.
862.3280..............  Heavy Metals       DIE          ................
                         Control
                         Materials.
862.3280..............  Drug Mixture       DIF          ................
                         Control
                         Materials.
862.3280..............  Digitoxin Control  DJK          ................
                         Serum, Ria.
862.3280..............  Alcohol Control    DKC          ................
                         Materials.
862.3280..............  Digoxin Control    DMP          ................
                         Serum, Ria.
862.3280..............  Drug Specific      LAS          ................
                         Control
                         Materials.
862.3280..............  Theophylline       LAW          ................
                         Control
                         Materials.
862.3280..............  Lidocaine Control  LAX          ................
                         Materials.
862.3280..............  Methotrexate       LAY          ................
                         Control
                         Materials.
862.3280..............  N-                 LAZ          ................
                         Acetylprocainami
                         de Control
                         Materials.
862.3280..............  Procainamide       LBA          ................
                         Control
                         Materials.
864.7040..............  ATP Release        JWR          ................
                         (Luminescence).
864.7040..............  Adenine            KHF          ................
                         Nucleotide
                         Quantitation.
866.2900..............  Device, Parasite   LKS          ................
                         Concentration.
872.4565..............  Parallelometer...  EGI          ................
872.4565..............  Syringe,           EIB          ................
                         Irrigating
                         (Dental).
876.5160..............  External Urethral  MNG          ................
                         Occluder,
                         Urinary
                         Incontinence-
                         Control, Female.
878.4014..............  Kit, First Aid,    OVR          ................
                         Talking.
880.5680..............  Pediatric          PRN          ................
                         Position Holder.
880.6250..............  Finger Cot.......  LZB          ................
880.6320..............  Device, Medical    KZF          ................
                         Examination, AC
                         Powered.
880.6320..............  Accessories to     PEQ          ................
                         Examination
                         Light.
880.6375..............  Lubricant,         KMJ          ................
                         Patient.
880.6760..............  Restraint,         BRT          ................
                         Patient,
                         Conductive.
880.6760..............  Restraint,         FMQ          ................
                         Protective.
880.6760..............  Patient Bed with   OYS          ................
                         Canopy/
                         Restraints.
882.1030..............  Ataxiagraph......  GWW          Exemption is
                                                         limited to
                                                         ataxiagraph
                                                         devices not
                                                         intended to
                                                         provide an
                                                         interpretation
                                                         or a clinical
                                                         implication of
                                                         the
                                                         measurement.
882.4060..............  Cannula,           HCD          ................
                         Ventricular.
882.4545..............  Instrument, Shunt  GYK          ................
                         System
                         Implantation.
884.5435..............  Pad, Menstrual,    NUQ          ................
                         Reusable.
884.5435..............  Pad, Interlabial.  NUR          ................

[[Page 17844]]

 
886.4070..............  Engine, Trephine,  HLD          ................
                         Accessories, Gas-
                         powered.
886.4070..............  Burr, Corneal,     HOG          ................
                         Battery-powered.
886.4070..............  Engine, Trephine,  HRF          ................
                         Accessories,
                         Battery-powered.
886.4070..............  Engine, Trephine,  HRG          ................
                         Accessories, AC-
                         powered.
886.4070..............  Burr, Corneal, AC- HQS          ................
                         powered.
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    Dated: April 7, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-07468 Filed 4-12-17; 8:45 am]
 BILLING CODE 4164-01-P