Acceptance Review for De Novo Classification Requests; Guidance for Industry and Food and Drug Administration Staff; Availability, 47310-47312 [2019-19350]
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Federal Register / Vol. 84, No. 174 / Monday, September 9, 2019 / Notices
Application No.
Drug
Applicant
NDA 020937 ...............
Optimark (gadoversetamide) Injection, 330.9 mg/mL .........
NDA 020947 ...............
Pennsaid (diclofenac sodium) Topical Solution, 1.5%
weight by weight (w/w).
Optimark (gadoversetamide) Injection, 330.9 mg/mL .........
Optimark (gadoversetamide) Injection, 330.9 mg/mL .........
Magnevist (gadopentetate dimeglumine) Injection, 469.01
mg/mL.
Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160
mg; and Phenazopyridine HCL Tablets, 200 mg.
Ketek (telithromycin) Tablets, 300 mg and 400 mg ............
Liebel-Flarsheim Co., LLC., 1034 South Brentwood Blvd.,
Suite 800, Richmond Heights, MO 63117.
Nuvo Pharmaceuticals, Inc., c/o Dwayne R.J. Moore, 41
Campus Dr., Suite 202, New Gloucester, ME 04260.
Liebel-Flarsheim Co., LLC.
Do.
Bayer HealthCare Pharmaceuticals, Inc.
NDA 020975 ...............
NDA 020976 ...............
NDA 021037 ...............
NDA 021105 ...............
NDA 021144 ...............
NDA 021178 ...............
NDA 021235 ...............
NDA 021490 ...............
NDA 022011 ...............
NDA 022154 ...............
NDA 022328 ...............
NDA 050456 ...............
NDA 204553 ...............
Eli Lilly and Co.
Allergan Pharmaceuticals International Limited, c/o
Allergan Sales, LLC., 5 Giralda Farms, Madison, NJ
07940.
Novartis Pharmaceuticals Corp.
Do.
Purdue Pharmaceutical Products L.P., 1 Stamford Forum,
Stamford, CT 06901–3431.
Alcon Laboratories, Inc., 6201 South Freeway, Mail Stop:
TC–45, Fort Worth, TX 76134–2099.
Tyzeka (telbivudine) Tablets, 600 mg .................................
Tyzeka (telbivudine) Solution, 100 mg/5 mL .......................
Intermezzo (zolpidem tartrate) Sublingual Tablets, 1.75
mg and 3.5 mg.
Statrol (neomycin sulfate and polymyxin B sulfate ophthalmic solution, USP) EQ 3.5 mg base/mL; equal to
16,250 units polymyxin B/mL.
ColPrep Kit (magnesium sulfate, potassium sulfate, and
sodium sulfate) for Oral Solution, 1.6 grams (g)/3.13 g/
17.5 g.
Dated: September 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–19348 Filed 9–6–19; 8:45 am]
BILLING CODE 4164–01–P
jbell on DSK3GLQ082PROD with NOTICES
Sanofi-Aventis U.S., LLC., 55 Corporate Dr., Bridgewater,
NJ 08807.
Bristol-Myers Squibb Co., P.O. Box 4000, Mail Stop:
D.2341, Princeton, NJ 08543–4000.
Glucovance (glyburide and metformin hydrocholoride
(HCl)) Tablets, 1.25 mg/250 mg, 2.5 mg/500 mg, 5 mg/
500 mg.
Prozac Weekly (fluoxetine delayed-release capsules) 90
mg.
Femcon Fe (ethinyl estradiol and norethindrone tablets,
0.035 mg/0.4 mg; and ferrous fumarate tablets, 75 mg).
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of October 9,
2019. Approval of each entire
application is withdrawn, including any
strengths and dosage forms
inadvertently missing from the table.
Introduction or delivery for introduction
into interstate commerce of products
without approved new drug
applications violates section 301(a) and
(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(a) and (d)).
Drug products that are listed in the table
that are in inventory on October 9, 2019
may continue to be dispensed until the
inventories have been depleted or the
drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
VerDate Sep<11>2014
Able Laboratories, Inc., 1 Able Dr., Cranbury, NJ 08512.
20:43 Sep 06, 2019
Jkt 247001
Gator Pharmaceuticals, Inc., 194 Inlet Dr., Saint Augustine, FL 32080.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–6069]
Acceptance Review for De Novo
Classification Requests; Guidance for
Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Acceptance Review
for De Novo Classification Requests.’’
The purpose of this guidance is to
explain the procedures and criteria FDA
intends to use in assessing whether a
request for an evaluation of automatic
class III designation (De Novo
classification request or De Novo
request) meets a minimum threshold of
acceptability and should be accepted for
substantive review. This guidance
discusses De Novo acceptance review
policies and procedures, ‘‘Refuse to
Accept’’ principles, and the elements of
the De Novo Acceptance Checklist and
the Recommended Content Checklist
and is being issued to be responsive to
an explicit deliverable identified in the
SUMMARY:
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Fmt 4703
Sfmt 4703
Medical Device User Fee Amendments
of 2017 (MDUFA IV).
DATES: The announcement of the
guidance is published in the Federal
Register on September 9, 2019.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
E:\FR\FM\09SEN1.SGM
09SEN1
Federal Register / Vol. 84, No. 174 / Monday, September 9, 2019 / Notices
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
jbell on DSK3GLQ082PROD with NOTICES
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2017–D–6069 for ‘‘Acceptance Review
for De Novo Classification Requests.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
VerDate Sep<11>2014
20:43 Sep 06, 2019
Jkt 247001
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance
document is available for download
from the internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the guidance
document entitled ‘‘Acceptance Review
for De Novo Classification Requests’’ to
the Office of the Center Director,
Guidance and Policy Development,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Rm. 5431, Silver Spring, MD 20993–
0002; or the Office of Communication,
Outreach, and Development, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, Silver Spring, MD 20993–0002.
Send one self-addressed adhesive label
to assist that office in processing your
request.
FOR FURTHER INFORMATION CONTACT:
Sergio de del Castillo, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1538,
Silver Spring, MD 20993–0002, 301–
796–6419; or Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
The automatic class III designation for
devices of a new type occurs by
operation of law and without any action
by FDA, regardless of the level of risk
posed by the device. Any device that is
of a new type that was not in
commercial distribution before May 28,
1976, is automatically classified as, and
remains within, class III and requires
premarket approval unless and until
FDA takes an action to classify or
reclassify the device under section
513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
360c(f)(1)). We refer to these devices as
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47311
‘‘postamendments devices’’ because
they were not in commercial
distribution prior to the date of
enactment of the Medical Device
Amendments of 1976.
FDA may classify a device through
the De Novo classification process,
which is the pathway authorized under
section 513(f)(2) of the FD&C Act. Upon
receipt of a De Novo request, FDA is
required to classify the device by
written order (section 513(f)(2)(A)(iii) of
the FD&C Act). The classification will
be according to the criteria under
section 513(a)(1) of the FD&C Act. Per
section 513(f)(2)(B)(i) of the FD&C Act,
the classification is the initial
classification of the device for the
purposes of section 513(f)(1) of the
FD&C Act.
We believe De Novo classification
enhances patients’ access to beneficial
innovation, in part by reducing
regulatory burdens. When FDA
classifies a device into class I or II via
the De Novo classification process, the
device can serve as a predicate for
future devices of that type, including for
510(k)s (section 513(f)(2)(B)(i)). As a
result, after a De Novo request is
granted, other device sponsors do not
have to submit a De Novo request or
premarket application under section 515
of the FD&C Act (21 U.S.C. 360e)) in
order to market a substantially
equivalent device (see 21 U.S.C. 360c(i),
‘‘defining substantial equivalence’’).
Instead, other device sponsors can use
the 510(k) process, when applicable, as
a pathway to market their device.
FDA is issuing this guidance to
provide clarity regarding the Agency’s
expectations for information to be
submitted in a De Novo request and
ensure predictability and consistency
for sponsors. Focusing the Agency’s
review resources on complete De Novo
requests will provide a more efficient
approach to ensuring that safe and
effective medical devices reach patients
as quickly as possible. Moreover, with
the enactment of MDUFA IV, FDA
agreed to issuance of draft and final
guidance, which includes a submission
checklist to facilitate a more efficient
and timely review process to assist with
new performance goals. Acceptance
review therefore takes on additional
importance in both encouraging quality
applications from De Novo requesters
and allowing the Agency to
appropriately concentrate resources on
complete applications.
FDA anticipates that the Agency and
industry may need a period of time to
operationalize the policies within this
guidance. Therefore, if all criteria
necessary to meet a minimum threshold
of acceptability for De Novo requests as
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09SEN1
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Federal Register / Vol. 84, No. 174 / Monday, September 9, 2019 / Notices
outlined in this guidance are not
included in a De Novo request received
by FDA before or up to 60 days after the
publication of this guidance, FDA staff
does not generally intend to refuse to
accept.
FDA considered comments received
on the draft guidance that appeared in
the Federal Register of October 30, 2017
(82 FR 50144). FDA revised the
guidance as appropriate in response to
the comments.
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Acceptance
Review for De Novo Classification
Requests.’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations. This guidance is not
subject to Executive Order 12866.
III. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm. This
guidance document is also available at
https://www.regulations.gov or from the
Center for Biologics Evaluation and
Research at https://www.fda.gov/
BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in the following FDA
regulations, guidance, and forms have
been approved by OMB as listed in the
following table:
21 CFR Part; guidance; or FDA form
Topic
‘‘De Novo Classification Process (Evaluation of Automatic
Class III Designation)‘‘.
807, subpart E .........................................................................
814, subparts A through E .......................................................
800, 801, and 809 ....................................................................
3 ...............................................................................................
807, 812, and 814 ....................................................................
De Novo classification process ...............................................
0910–0844
Premarket notification .............................................................
Premarket approval .................................................................
Medical Device Labeling Regulations .....................................
Combination products; Request for Designation ....................
Human Subject Protection; Acceptance of Data from Clinical
Studies for Medical Devices.
Financial disclosure by clinical investigators ..........................
0910–0120
0910–0231
0910–0485
0910–0523
0910–0741
54 (Forms FDA 3454 and 3455) .............................................
Dated: September 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–19350 Filed 9–6–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–P–4186]
Determination That CALCIMAR
(calcitonin salmon) Injection, 200
International Units Per Milliliter, Was
Not Withdrawn From Sale for Reasons
of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that CALCIMAR (calcitonin
salmon) Injection, 200 International
Units per milliliter (IU/mL), was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for CALCIMAR
(calcitonin salmon) Injection, 200 IU/
SUMMARY:
jbell on DSK3GLQ082PROD with NOTICES
default.htm. Persons unable to
download an electronic copy of
‘‘Acceptance Review for De Novo
Classification Requests’’ may send an
email request to CDRH-Guidance@
fda.hhs.gov to receive an electronic
copy of the document. Please use the
document number 16055 to identify the
guidance you are requesting.
VerDate Sep<11>2014
20:43 Sep 06, 2019
Jkt 247001
mL, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT: Nam
Kim, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6272, Silver Spring,
MD 20993–0002, 301–796–3472.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
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OMB control No.
0910–0396
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
CALCIMAR (calcitonin salmon)
injection, 200 IU/mL, is the subject of
NDA 017769, held by Sanofi Aventis,
and initially approved on April 17,
1978. CALCIMAR is indicated for
Paget’s disease of bone, hypercalcemia,
and postmenopausal osteoporosis.
CALCIMAR (calcitonin salmon)
injection, 200 IU/mL, is currently listed
E:\FR\FM\09SEN1.SGM
09SEN1
]]>Agencies
[Federal Register Volume 84, Number 174 (Monday, September 9, 2019)]
[Notices]
[Pages 47310-47312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19350]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-6069]
Acceptance Review for De Novo Classification Requests; Guidance
for Industry and Food and Drug Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Acceptance Review for
De Novo Classification Requests.'' The purpose of this guidance is to
explain the procedures and criteria FDA intends to use in assessing
whether a request for an evaluation of automatic class III designation
(De Novo classification request or De Novo request) meets a minimum
threshold of acceptability and should be accepted for substantive
review. This guidance discusses De Novo acceptance review policies and
procedures, ``Refuse to Accept'' principles, and the elements of the De
Novo Acceptance Checklist and the Recommended Content Checklist and is
being issued to be responsive to an explicit deliverable identified in
the Medical Device User Fee Amendments of 2017 (MDUFA IV).
DATES: The announcement of the guidance is published in the Federal
Register on September 9, 2019.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the
[[Page 47311]]
public, submit the comment as a written/paper submission and in the
manner detailed (see ``Written/Paper Submissions'' and
``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2017-D-6069 for ``Acceptance Review for De Novo Classification
Requests.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Acceptance Review for De Novo Classification Requests'' to the Office
of the Center Director, Guidance and Policy Development, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002;
or the Office of Communication, Outreach, and Development, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request.
FOR FURTHER INFORMATION CONTACT: Sergio de del Castillo, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 1538, Silver Spring, MD 20993-0002,
301-796-6419; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
The automatic class III designation for devices of a new type
occurs by operation of law and without any action by FDA, regardless of
the level of risk posed by the device. Any device that is of a new type
that was not in commercial distribution before May 28, 1976, is
automatically classified as, and remains within, class III and requires
premarket approval unless and until FDA takes an action to classify or
reclassify the device under section 513(f)(1) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360c(f)(1)). We refer to
these devices as ``postamendments devices'' because they were not in
commercial distribution prior to the date of enactment of the Medical
Device Amendments of 1976.
FDA may classify a device through the De Novo classification
process, which is the pathway authorized under section 513(f)(2) of the
FD&C Act. Upon receipt of a De Novo request, FDA is required to
classify the device by written order (section 513(f)(2)(A)(iii) of the
FD&C Act). The classification will be according to the criteria under
section 513(a)(1) of the FD&C Act. Per section 513(f)(2)(B)(i) of the
FD&C Act, the classification is the initial classification of the
device for the purposes of section 513(f)(1) of the FD&C Act.
We believe De Novo classification enhances patients' access to
beneficial innovation, in part by reducing regulatory burdens. When FDA
classifies a device into class I or II via the De Novo classification
process, the device can serve as a predicate for future devices of that
type, including for 510(k)s (section 513(f)(2)(B)(i)). As a result,
after a De Novo request is granted, other device sponsors do not have
to submit a De Novo request or premarket application under section 515
of the FD&C Act (21 U.S.C. 360e)) in order to market a substantially
equivalent device (see 21 U.S.C. 360c(i), ``defining substantial
equivalence''). Instead, other device sponsors can use the 510(k)
process, when applicable, as a pathway to market their device.
FDA is issuing this guidance to provide clarity regarding the
Agency's expectations for information to be submitted in a De Novo
request and ensure predictability and consistency for sponsors.
Focusing the Agency's review resources on complete De Novo requests
will provide a more efficient approach to ensuring that safe and
effective medical devices reach patients as quickly as possible.
Moreover, with the enactment of MDUFA IV, FDA agreed to issuance of
draft and final guidance, which includes a submission checklist to
facilitate a more efficient and timely review process to assist with
new performance goals. Acceptance review therefore takes on additional
importance in both encouraging quality applications from De Novo
requesters and allowing the Agency to appropriately concentrate
resources on complete applications.
FDA anticipates that the Agency and industry may need a period of
time to operationalize the policies within this guidance. Therefore, if
all criteria necessary to meet a minimum threshold of acceptability for
De Novo requests as
[[Page 47312]]
outlined in this guidance are not included in a De Novo request
received by FDA before or up to 60 days after the publication of this
guidance, FDA staff does not generally intend to refuse to accept.
FDA considered comments received on the draft guidance that
appeared in the Federal Register of October 30, 2017 (82 FR 50144). FDA
revised the guidance as appropriate in response to the comments.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Acceptance Review for De Novo
Classification Requests.'' It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations. This guidance is not subject to Executive
Order 12866.
III. Electronic Access
Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov or
from the Center for Biologics Evaluation and Research at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to
download an electronic copy of ``Acceptance Review for De Novo
Classification Requests'' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number 16055 to identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in
the following FDA regulations, guidance, and forms have been approved
by OMB as listed in the following table:
------------------------------------------------------------------------
21 CFR Part; guidance; or FDA
form Topic OMB control No.
------------------------------------------------------------------------
``De Novo Classification Process De Novo 0910-0844
(Evaluation of Automatic Class classification
III Designation)``. process.
807, subpart E.................. Premarket 0910-0120
notification.
814, subparts A through E....... Premarket approval. 0910-0231
800, 801, and 809............... Medical Device 0910-0485
Labeling
Regulations.
3............................... Combination 0910-0523
products; Request
for Designation.
807, 812, and 814............... Human Subject 0910-0741
Protection;
Acceptance of Data
from Clinical
Studies for
Medical Devices.
54 (Forms FDA 3454 and 3455).... Financial 0910-0396
disclosure by
clinical
investigators.
------------------------------------------------------------------------
Dated: September 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-19350 Filed 9-6-19; 8:45 am]
BILLING CODE 4164-01-P
