Federal Register / Vol. 86, No. 150 / Monday, August 9, 2021 / Notices 43553 

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. 

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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43554 Federal Register / Vol. 86, No. 150 / Monday, August 9, 2021 / Notices 

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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Federal Register / Vol. 86, No. 150 / Monday, August 9, 2021 / Notices 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 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/genericdrug-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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–0868] 

Development and Submission of Near 

Infrared Analytical Procedures; 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry entitled 

‘‘Development and Submission of Near 

Infrared Analytical Procedures.’’ This 

guidance provides recommendations to 

applicants to aid the development, 

validation, and use of near infrared 

(NIR)-based analytical procedures in 

evaluating the identity, strength, 

quality, purity, and potency of drug 

substances and drug products. The 

recommendations apply to new drug 

applications (NDAs), abbreviated new 

drug applications (ANDAs), and 

supplemental NDAs and ANDAs for 

small molecule drugs. The principles in 

this guidance also apply to drug 

substances and drug products covered 

in Type II drug master files. This 

guidance finalizes the draft guidance of 

the same title issued on March 31, 2015. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on August 9, 2021. 

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. 


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