Notice2021-16944
Genus Medical Technologies LLC Versus Food and Drug Administration; Request for Information and Comments
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Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 9, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing that implementation of a decision from the U.S. Court of Appeals for the District of Columbia Circuit in Genus Med. Techs., LLC v. FDA, 2021 U.S. App. Lexis 10928 (April 16, 2021) is expected to require some approved products to transition from drug status to device status. This notice provides information for stakeholders and solicits public comment to inform the Agency's deliberations about products potentially impacted by the Genus decision and the way in which impacted products should be transitioned from drug to device status.
Full Text
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<title>Federal Register, Volume 86 Issue 150 (Monday, August 9, 2021)</title>
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[Federal Register Volume 86, Number 150 (Monday, August 9, 2021)]
[Notices]
[Pages 43553-43555]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-16944]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0843]
Genus Medical Technologies LLC Versus Food and Drug
Administration; Request for Information and Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for information and comments.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
that implementation of a decision from the U.S. Court of Appeals for
the District of Columbia Circuit in Genus Med. Techs., LLC v. FDA, 2021
U.S. App. Lexis 10928 (April 16, 2021) is expected to require some
approved products to transition from drug status to device status. This
notice provides information for stakeholders and solicits public
comment to inform the Agency's deliberations about products potentially
impacted by the Genus decision and the way in which impacted products
should be transitioned from drug to device status.
DATES: Submit either electronic or written information and comments by
October 8, 2021.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before October 8, 2021. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of October 8, 2021. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the 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:
<bullet> 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.
<bullet> 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-2021-N-0843 for ``Genus Medical Technologies LLC v. Food and Drug
Administration; Request for Information and Comments.'' Received
comments, those received in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Alexandra Lucas, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993, 301-796-0230,
<a href="/cdn-cgi/l/email-protection#2a6e585f4d756e4f5c43494f757e584b4459435e4345447563445b5f4358536a4c4e4b04424259044d455c"><span class="__cf_email__" data-cfemail="a6e2d4d3c1f9e2c3d0cfc5c3f9f2d4c7c8d5cfd2cfc9c8f9efc8d7d3cfd4dfe6c0c2c788ceced588c1c9d0">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
On April 16, 2021, the U.S. Court of Appeals for the District of
Columbia Circuit issued its decision in Genus Med. Techs., LLC v. FDA,
2021 U.S. App. Lexis 10928 (April 16, 2021). The U.S. Government has
decided not to appeal this decision.
At issue in the Genus litigation was FDA's regulatory
classification of certain barium sulfate contrast imaging agents as
drugs. Barium sulfate contrast imaging agents are used to improve
visualization of the gastrointestinal tract in radiographic diagnostic
studies. They meet the definition of drug in section 201(g) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(g))
because they are articles intended for use in the diagnosis of disease.
In its January 10, 2019, designation letter for Genus's barium sulfate
contrast imaging agents, FDA explained that it has regulated barium
sulfate contrast imaging agents as drugs even though they also appear
to meet the definition of device in section 201(h) of the FD&C Act.
Although FDA has generally regulated products that meet the device
definition under the device authorities of the FD&C Act, we have
regulated as drugs certain types of products that meet the drug
definition and may also meet the device definition. FDA's
classification of all contrast imaging agents, including barium
[[Page 43554]]
sulfate contrast agents, as drugs allowed us to regulate them
consistently under the same authority in the Center for Drug Evaluation
and Research (CDER) and was intended to be consistent with a previous
court decision, Bracco Diagnostics, Inc. v. Shalala, 963 F. Supp. 20
(D.D.C. 1997).
In the Genus litigation, both the District Court and the Court of
Appeals, as a matter of statutory interpretation, disagreed with FDA's
view that the Agency had discretion to regulate products meeting the
device definition as drugs. The Court of Appeals determined that FDA
cannot classify as a drug any product that meets the definition of
device, stating ``[e]xcepting combination products, . . . devices must
be regulated as devices and drugs--if they do not also satisfy the
device definition--must be regulated as drugs.''
II. Discussion
A. Product Classification Decisions Going Forward
FDA has issued guidance on its approach to classification decisions
for drugs and devices. (See FDA's guidance for industry and FDA staff
``Classification of Products as Drugs and Devices & Additional Product
Classification Issues'' (September 2017), available at <a href="https://www.fda.gov/media/80384/download">https://www.fda.gov/media/80384/download</a>.) That guidance reviews the
definitions of the terms drug and device found in section 201(g) and
(h) of the FD&C Act, respectively. Both definitions include similar
``intended use'' clauses, with drugs including ``articles intended for
use in the diagnosis, cure, mitigation, treatment, or prevention of
disease in man or other animals . . . and articles (other than food)
intended to affect the structure or any function of the body of man or
other animals'' and devices including certain articles ``intended for
use in the diagnosis of disease or other conditions, or in the cure,
mitigation, treatment, or prevention of disease, in man or other
animals . . . or [articles] intended to affect the structure or any
function of the body of man or other animals.'' A medical product meets
the device definition if it (1) is an instrument, apparatus, implement,
machine, contrivance, implant, in vitro reagent, or other similar or
related article, including any component, part, or accessory, and (2)
does not achieve its primary intended purposes through chemical action
within or on the body, and (3) is not dependent upon being metabolized
for the achievement of its primary intended purposes.
Going forward, in accordance with Genus, FDA intends to regulate
products that meet both the device and drug definition as devices,
except where the statute indicates that Congress intended a different
classification, and we further intend to bring previously classified
products into line with the Genus decision. Accordingly, FDA will
examine product classifications, paying particular attention to those
products that have been regulated as drugs even though they may satisfy
the device definition. We expect the determining factor in many cases
to be whether the product achieves its primary intended purposes
through chemical action within or on the body or is dependent upon
being metabolized for the achievement of its primary intended purposes.
Historically, FDA has not always examined these factors in determining
how to regulate certain types of medical products--e.g., imaging
agents, which are discussed further below--because the Agency believed
it had discretion to regulate such products as drugs even if they met
the device definition. In determining product classification in the
future, FDA will consider these factors. FDA will also examine whether
other statutory provisions--beyond the drug and device definitions--
indicate Congress intended a type of product to be regulated under
either the drug or device authorities.
B. Imaging Agents
Some medical imaging techniques can depend solely on an imaging
device to produce and display images. These techniques include
ultrasound, computerized tomography (CT), magnetic resonance imaging
(MRI), and traditional radiology. However, imaging agents are sometimes
used in conjunction with these imaging devices to provide image
enhancement. For example, with CT and MRI, the addition of an imaging
agent may improve the visualization of tissues, organs, and physiologic
processes in part by increasing the relative difference of imaging
signal intensities in adjacent regions of the body. In other cases,
such as radiopharmaceutical imaging, including single photon emission
computerized tomography and positron emission computerized tomography,
the device alone cannot produce a usable image, and it is necessary to
administer an imaging agent to the patient before using the imaging
device.
For the past two decades, FDA has generally regulated the imaging
agents used in these procedures as drugs without consideration of
whether they appear to achieve their primary intended purposes through
chemical action within or on the body or whether they are dependent
upon metabolization for the achievement of their primary intended
purposes. Following the Genus decision, we intend to reexamine whether
individual imaging agents meet the device definition, including whether
they achieve their primary intended purposes through chemical action
within or on the body or are dependent upon being metabolized for the
achievement of their primary intended purposes. As noted above, we
intend to reexamine other product categories as well, as appropriate.
C. Product Transition Issues
Implementation of the Genus decision will require FDA to transition
some approved products from drug status to device status. FDA will aim
to effect necessary product transitions in a way that does not disrupt
the supply of these important medical products or place undue burden on
manufacturers or on the healthcare delivery system. Some operational
issues raised by product transitions necessitated by Genus are
discussed briefly below.
1. Categories of Products Implicated by Genus
Stakeholders are invited to submit comments regarding categories of
products currently regulated as drugs that may be required to
transition to device status under Genus. Comments are also welcome
regarding statutory provisions other than the drug and device
definitions that may indicate Congressional intention regarding the
appropriate regulatory pathway (i.e., drug or device) for certain types
of products.
2. Transition Process
FDA currently anticipates that it will publish in a future Federal
Register notice a list of approved drug products that we tentatively
determine should transition to device status under Genus. Stakeholders
would then have an opportunity to comment on those tentative
determinations before classification determinations are made.
3. Transition Timing
We recognize that there are differences between the drug regulatory
requirements and the device regulatory requirements and that sponsors
of transitioning marketed products will need time to transition from
compliance with one to the other. For example, sponsors of
transitioning products may need to update labeling, bring facilities
into compliance with quality system regulations, prepare for device
inspections, and come into compliance
[[Page 43555]]
with other statutory and regulatory provisions that pertain to devices.
Therefore, stakeholders are invited to submit comments on timelines
necessary for this transition and how FDA can facilitate this
transition in a way that does not disrupt the supply of these important
medical products or place undue burden on manufacturers or on the
healthcare delivery system.
4. User Fee Transitions
CDER assesses user fees for certain new drug applications (NDAs)
and products approved under those NDAs under the Prescription Drug User
Fee Amendments (PDUFA). CDER also assesses user fees for certain
abbreviated new drug applications (ANDAs) and products approved under
those ANDAs under the Generic Drug User Fee Amendments (GDUFA). The
PDUFA and GDUFA user fee programs both include specific fees assessed
annually for certain marketed approved products.
In the case of PDUFA, with certain exceptions or exemptions, annual
prescription drug program fees are assessed for each strength of a
prescription drug identified in an approved NDA, as of October 1 of
each fiscal year (FY), provided the product is included in the
``Prescription Drug Product List'' (the ``active section'') of Approved
Drug Products with Therapeutic Equivalence Evaluations (commonly known
as the ``Orange Book'').
In the case of GDUFA, annual GDUFA program fees are assessed with
respect to approved ANDAs, and fee amounts are tiered based on the
number of approved ANDAs owned by an entity (including its affiliates)
as of October 1 of each fiscal year. GDUFA also includes an annual
facility fee for each facility referenced in an approved ANDA as a
producer of an active pharmaceutical ingredient or finished dosage form
covered by the ANDA.
FDA does not anticipate that the identification and transitioning
of products from drug status to device status pursuant to the Genus
decision will be completed before October 1, 2021. Persons assessed an
annual fee with respect to a product identified in an approved NDA or
ANDA as of that date should pay the assessed FY 2022 fees by the due
date to avoid being placed on the arrears list and incurring other
penalties associated with failure to pay user fees by the due date.
Payors of the annual FY 2022 fee with respect to a product that the
payor believes should transition to device status under Genus are
encouraged to request refunds of user fees attributable to those
products. FDA anticipates that, for approved products that transition
from drug status to device status under the process described above,
refund requests for PDUFA and GDUFA fees that are received on time
under section 736(i) or 744B(m) of the FD&C Act (21 U.S.C. 379h(i) or
379j-42(m)), respectively, will be granted. This would include requests
for refund of the FY 2022 prescription drug program fees assessed under
PDUFA, or FY 2022 generic drug applicant program fees assessed under
GDUFA that may result in a lower fee tier for an ANDA holder, as well
as any GDUFA facility fees for a facility referenced in one or more
ANDAs that will transition, if that facility is not also reported in
other ANDAs that will not transition. Under PDUFA, to qualify for
consideration for a refund, a written request must be submitted to FDA
not later than 180 calendar days after the fee is due (see section
736(i) of the FD&C Act). Under GDUFA, to qualify for a return of a fee,
a written request justifying the return must be submitted within 180
calendar days from the date of the fee payment (see section 744B(m) of
the FD&C Act).
More information about PDUFA and GDUFA fees and the submission of
refund requests is available on FDA's website at <a href="https://www.fda.gov/industry/fda-user-fee-programs/prescription-drug-user-fee-amendments">https://www.fda.gov/industry/fda-user-fee-programs/prescription-drug-user-fee-amendments</a>
(PDUFA) and <a href="https://www.fda.gov/industry/fda-user-fee-programs/generic-drug-user-fee-amendments">https://www.fda.gov/industry/fda-user-fee-programs/generic-drug-user-fee-amendments</a> (GDUFA).
5. Determining Drug or Device Status
FDA intends to establish a process for the orderly and efficient
determination of which products currently regulated as drugs must be
regulated as devices under Genus. We encourage sponsors of potentially
affected products to comment on this notice, await the publication of
our future notice identifying products that we have tentatively
determined should transition to device status, and, in the meantime,
reach out to FDA with time-sensitive questions.
FDA has established the following contact point for all questions
concerning the Genus decision and transition activities:
<a href="/cdn-cgi/l/email-protection#f1b5838496aeb59487989294aea583909f829885989e9faeb89f8084988388b1979590df999982df969e87"><span class="__cf_email__" data-cfemail="2d695f584a7269485b444e4872795f4c435e44594442437264435c58445f546d4b494c0345455e034a425b">[email protected]</span></a>.
Dated: August 2, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16944 Filed 8-6-21; 8:45 am]
BILLING CODE 4164-01-P
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