[Federal Register Volume 86, Number 150 (Monday, August 9, 2021)]
[Notices]
[Pages 43553-43555]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     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 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-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 https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
     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.govinfo.gov/content/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, 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, 
Drug_Device_Transition_Inquiry@fda.hhs.gov.

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

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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 https://www.fda.gov/media/80384/download.) 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

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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 https://www.fda.gov/industry/fda-user-fee-programs/prescription-drug-user-fee-amendments 
(PDUFA) and https://www.fda.gov/industry/fda-user-fee-programs/generic-drug-user-fee-amendments (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: 
Drug_Device_Transition_Inquiry@fda.hhs.gov.

    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


