[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
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Partial
Product exemption
21 CFR section Device type code limitation (if
applicable)
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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