83774 Federal Register / Vol. 88, No. 229 / Thursday, November 30, 2023 / Proposed Rules 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 878 

[Docket No. FDA–2023–N–3392] 

RIN 0910–A126 

Medical Devices; General and Plastic 

Surgery Devices; Classification of 

Certain Solid Wound Dressings; 

Wound Dressings Formulated as a Gel, 

Creams, or Ointment; and Liquid 

Wound Washes 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 

are proposing to classify certain types of 

wound dressings and liquid wound 

washes containing antimicrobials and/ 

or other chemicals (unclassified, 

preamendments devices) as solid 

wound dressings; wound dressings 

formulated as a gel, cream, or ointment; 

and liquid wound washes. FDA 

currently regulates these unclassified 

devices as devices requiring premarket 

notification (510(k) requirements), with 

the product codes FRO, GER, MGP, 

MGQ, and EFQ, but FDA intends to 

create new product codes for these 

proposed classifications upon 

finalization of this classification action. 

FDA is proposing to classify certain 

wound dressings and liquid wound 

washes containing antimicrobials with a 

high level of antimicrobial resistance 

(AMR) concern (i.e., medically 

important antimicrobials) into class III. 

In addition, FDA is proposing to classify 

certain wound dressings and liquid 

wound washes containing 

antimicrobials with a medium or low 

level of AMR concern and/or other 

chemicals, into class II (subject to 

special controls and 510(k) 

requirements). 

DATES: Either electronic or written 

comments on the proposed rule must be 

submit by February 28, 2024. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

February 28, 2024. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

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– 

2023–N–3392 for ‘‘Medical Devices; 

General and Plastic Surgery Devices; 

Classification of Certain Solid Wound 

Dressings; Wound Dressings Formulated 

as a Gel, Creams, or Ointment; and 

Liquid Wound Washes.’’ Received 

comments, those filed 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: 

Brandon Kitchel, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4626, Silver Spring, 

MD 20993–0002, 301–796–6055, 

brandon.kitchel@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Executive Summary 

A. Purpose of the Proposed Rule 

B. Summary of the Major Provisions of the 

Proposed Rule 

C. Legal Authority 

D. Costs and Benefits 

II. Table of Abbreviations/Acronyms 

Commonly Used Acronyms in This 

Document 

III. Background 

A. Need for the Regulation 

B. Terminology 

C. FDA’s Current Regulatory Framework 

D. History of This Rulemaking 

IV. Legal Authority 

V. Description of the Proposed Rule 

A. Scope/Applicability 


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1We refer to these products as devices because of 

their device mode of action, although, as noted later 

in the document, many of the products with wound 

management claims, based on a broad interpretation 

of such claims, have previously been generally 

identified as combination products. As explained 

later in the document, one of the purposes of this 

rulemaking is to clarify the intended uses of these 

products for classification purposes, based on the 

recommendations of the General and Plastic 

Surgery Devices Panel, by proposing not to include 

broad ‘‘wound management’’ claims in product 

labeling and be clarified to reflect the specific 

functions discussed in this document (e.g., ‘‘to 

protect and cover a wound’’). Products that 

continue to have broad wound management claims, 

which may be unclear or misleading or indicate an 

objective intent outside of the clarified intended 

uses, will not be covered by and benefit from this 

proposed rulemaking and classification. After this 

proposed rule is finalized and the classification 

becomes effective, such products could be subject 

to a different type of marketing authorization, 

depending on the product claims. For example, 

products containing antimicrobials that make 

certain wound managements claims may be 

considered combination products or drugs and 

regulated as such. 

2FDA’s Center for Devices and Radiological 

Health (CDRH) uses product codes to help 

categorize and assure consistent regulation of 

medical devices. A product code consists of three 

characters that are assigned at the time a product 

code is generated and is unique to a product type. 

The three characters carry no other significance and 

are not an abbreviation. 

3See ‘‘Medical Device Classification Product 

Codes—Guidance for Industry and FDA Staff,’’ 

available at: https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/ 

medical-device-classification-product-codesguidance-industry-and-food-and-drugadministration-staff. 

4See definition of combination product at 21 CFR 

3.2(e). 

5For information on the classification of products 

as drugs, devices, or biological products, please see 

the guidance ‘‘Classification of Products as Drugs 

and Devices and Additional Product Classification 

Issues,’’ available at https://www.fda.gov/media/ 

80384/download. 

6For the purposes of this proposed rule and 

classification action, medically important 

antimicrobials are antimicrobial drugs that are 

important for therapeutic use in humans and 

associated with a high level of AMR concern. WHO 

has worked to categorize medically important 

antimicrobials based on the level of importance 

these drugs play in human medicine (https://

www.who.int/publications/i/item/9789241515528). 

While the Agency has made similar efforts to 

categorize medically important antimicrobials, such 

as the work to address the use of medically 

important antimicrobial drugs in food-producing 

animals (https://www.fda.gov/media/172347/ 

download?attachment), the current classification 

efforts do not attempt to further stratify the degree 

of importance of these antimicrobial drugs. 

7For the purposes of this proposed rule and 

classification action, antimicrobial resistance is the 

ability of a microorganism (e.g., bacteria or fungi) 

to resist the effects of an antimicrobial. 

B. Device Description 

C. Risks to Health and Public Health 

Benefits 

D. Proposed Classification and FDA’s 

Findings 

VI. Proposed Effective/Compliance Dates 

A. Devices That Are Proposed To Be 

Classified Into Class III 

B. Devices That Are Proposed To Be 

Classified Into Class II 

VII. Preliminary Economic Analysis of 

Impacts 

VIII. Analysis of Environmental Impact 

IX. Paperwork Reduction Act of 1995 

X. Federalism 

XI. Consultation and Coordination With 

Indian Tribal Governments 

XII. References 

I. Executive Summary 

A. Purpose of the Proposed Rule 

FDA is proposing to classify certain 

unclassified, preamendments wound 

dressings and liquid wound washes 

containing antimicrobials and/or other 

chemicals into three separate 

classification regulations: (1) solid 

wound dressings; (2) wound dressings 

formulated as a gel, cream, or ointment; 

and (3) liquid wound washes. A list of 

examples of antimicrobials and a list of 

categories and examples of other 

chemicals contemplated by this 

proposed rule are found in table 2 and 

table 3, respectively. For solid wound 

dressings, the intended use is to cover 

and protect a wound, to absorb exudate, 

and to maintain appropriate moisture 

balance within the wound. For wound 

dressings formulated as a gel, cream, or 

ointment, the intended use is to 

maintain appropriate moisture balance 

within the wound. For liquid wound 

washes, the intended use is to 

mechanically irrigate and physically 

remove debris from external wounds. It 

is also to moisten solid wound dressings 

to maintain appropriate moisture 

balance within the dressing. 

FDA currently regulates these 

unclassified devices 1 as devices 

requiring premarket notification (510(k) 

requirements), with the product codes 

FRO, GER, MGP, MGQ, and EFQ.2 FDA 

intends to create new product codes for 

these proposed classifications upon 

finalization of this classification action.3

This proposed classification is based, in 

part, on the recommendations of 

multiple General and Plastic Surgery 

Devices Panel meetings (held on 

November 27, 1998 (Ref. 1), August 25 

and 26, 2005 (Ref. 2), and September 20 

and 21, 2016 (Ref. 3)) regarding the 

classification of wound dressings, 

public comments received on such 

recommendations, FDA’s experience 

with these wound dressings and liquid 

wound washes, and other available 

information. 

As discussed further in this preamble, 

FDA believes that with clarification of 

intended use claims, wound dressings 

and liquid wound washes subject to this 

proposed rule, including those with 

antimicrobials, should be regulated only 

as ‘‘devices’’ and not as combination 

products.4 These products, though 

perhaps previously identified as 

combination products, are within the 

scope of this classification. 

Additionally, wound dressings and 

liquid wound washes that do not 

contain a component that achieves a 

primary intended purpose of the 

product through chemical action within 

or on the body are considered devices, 

even if these products contain 

components that are regulated as drugs 

in other contexts.5 Further discussion of 

these products is included in the 

intended use(s) section under section 

V.B. 

The proposed classification for solid 

wound dressings is intended to be a 

split classification. FDA is proposing to 

classify solid wound dressings 

containing medically important 

antimicrobials acting as protectants (Ref. 

4) 6 into class III due to their high level 

of antimicrobial resistance (AMR) 7

concern (as discussed in Section III.B 

Terminology). Table 1 of the World 

Health Organization’s (WHO) 2018 

publication ‘‘Critically Important 

Antimicrobials for Human Medicine: 

6th Edition’’ (Ref. 4) has a list of all 

classes of medically important 

antimicrobials. For the purposes of this 

proposed rule, an antimicrobial is 

considered medically important if, and 

only if, it falls within any of these 

classes regardless of the level of 

importance specified by the WHO (i.e., 

critically important, highly important, 

or important). FDA is proposing this 

classification as FDA believes that 

insufficient information exists to 

determine that general controls and 

special controls would provide 

reasonable assurance of safety and 

effectiveness for such wound dressings, 

and these dressings present a potential 

unreasonable risk of illness or injury. 

FDA is proposing, by proposed order 

published elsewhere in this issue of the 

Federal Register, to require the filing of 

premarket approval applications (PMAs) 

for such devices. 

FDA is proposing to classify solid 

wound dressings containing 

antimicrobials that are acting as 

protectants with medium or low level of 

AMR concern and/or other chemicals 

into class II (special controls). Please see 

Section III.B Terminology for more 

information on antimicrobials that are 

acting as protectants and on other 

chemicals. Antimicrobials acting as 

protectants are used to reduce microbial 

growth within the dressing while in use 

or to provide an antimicrobial barrier to 

microbial penetration through the 

dressing. FDA is proposing this 

classification action based on the 

determination that general controls 


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alone are not sufficient to provide 

reasonable assurance of the safety and 

effectiveness of these solid wound 

dressings, and there is sufficient 

information to establish special 

controls, in combination with general 

controls, to provide such assurance. 

Similarly, FDA is proposing a split 

classification for wound dressings 

formulated as a gel, cream, or ointment. 

FDA is proposing to classify wound 

dressings formulated as a gel, cream, or 

ointment containing medically 

important antimicrobials acting as 

preservatives into class III due to their 

high level of AMR concern. FDA is 

proposing this classification as FDA 

believes that insufficient information 

exists to determine that general controls 

and special controls would provide 

reasonable assurance of safety and 

effectiveness for such wound dressings 

and that these dressings present a 

potential unreasonable risk of illness or 

injury. FDA is proposing, by proposed 

order published elsewhere in this issue 

of the Federal Register, to require the 

filing of PMAs for such devices. 

FDA proposes to classify wound 

dressings formulated as a gel, cream, or 

ointment containing antimicrobials 

acting as preservatives (as discussed in 

Section III.B Terminology) with medium 

or low AMR risk and/or other chemicals 

into class II. Antimicrobials acting as 

preservatives are used to maintain shelf 

life for a nonsterile, single-use wound 

dressing or a multiple-use wound 

dressing for single patient use only with 

compromised sterility after opening and 

using for a defined period. FDA is 

proposing this action based on the 

determination that general controls 

alone are not sufficient to provide 

reasonable assurance of the safety and 

effectiveness of these wound dressings, 

and there is sufficient information to 

establish special controls, in 

combination with general controls, to 

provide such assurance. 

FDA is also proposing a split 

classification for liquid wound washes. 

FDA is proposing to classify liquid 

wound washes containing medically 

important antimicrobials acting as 

preservatives into class III due to their 

high level of AMR concern. FDA is 

proposing this classification as FDA 

believes that insufficient information 

exists to determine that general controls 

and special controls would provide 

reasonable assurance of safety and 

effectiveness for such liquid wound 

washes and these washes present a 

potential unreasonable risk of illness or 

injury. FDA is proposing, by proposed 

order published elsewhere in this issue 

of the Federal Register, to require the 

filing of PMAs for such devices. 

FDA is proposing to classify liquid 

wound washes containing 

antimicrobials acting as preservatives 

with medium or low level AMR concern 

and/or other chemicals into class II. 

FDA is proposing this classification 

action based on the determination that 

general controls alone are not sufficient 

to provide reasonable assurance of the 

safety and effectiveness of these wound 

washes and that there is sufficient 

information to establish special 

controls, in combination with general 

controls, to provide such assurance. 

Additionally, if this proposed rule is 

finalized, FDA plans to publish a notice 

in the Federal Register announcing its 

intent to exempt liquid wound washes 

containing water or 0.9 percent saline 

only, which do not contain 

antimicrobials, other chemicals, or 

animal-derived materials, from the 

requirements of submitting a 510(k), 

subject to certain limitations, under the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act). 

B. Summary of the Major Provisions of 

the Proposed Rule 

This rule proposes to classify certain 

of the following unclassified, 

preamendments wound dressings and 

liquid wound washes containing 

antimicrobials and/or other chemicals: 

(1) solid wound dressings; (2) wound 

dressings formulated as a gel, cream, or 

ointment; and (3) liquid wound washes. 

The proposed rule, if finalized, would 

establish the identifications and 

classifications for certain solid wound 

dressings; wound dressings formulated 

as a gel, cream, or ointment; and liquid 

wound washes. 

The proposed classification action 

proposes to classify into class III and 

require the filing of a PMA for wound 

dressings and liquid wound washes 

(i.e., solid wound dressings; wound 

dressings formulated as a gel, cream, or 

ointment; and liquid wound washes) 

containing medically important 

antimicrobials used for preservative or 

protectant purposes. This proposed 

classification action proposes also to 

classify solid wound dressings 

containing antimicrobials acting as 

protectants with a medium or low level 

of AMR concern and/or other chemicals 

into class II. Wound dressings 

formulated as a gel, cream, or ointment 

and liquid wound washes containing 

antimicrobials acting as preservatives 

with a medium or low level of AMR 

concern and/or other chemicals are 

being proposed for classification into 

class II. These certain class II wound 

dressings and liquid wound washes 

would be classified with special 

controls that require specific 

information relating to performance 

testing and technical specifications, 

specific labeling requirements, and 

other requirements to mitigate the risks 

to health and demonstrate a reasonable 

assurance of safety and effectiveness, in 

combination with general controls. 

If this proposed rule is finalized, FDA 

plans to exempt from 510(k) certain 

liquid wound washes containing water 

or 0.9 percent saline only, which do not 

contain antimicrobials, other chemicals, 

or animal-derived materials, subject to 

certain limitations. An exemption from 

the requirement of 510(k) does not mean 

that the device type is exempt from any 

other statutory or regulatory 

requirements unless such exemption is 

explicitly provided by order or 

regulation. 

C. Legal Authority 

The Agency is proposing this 

classification under the authority of 

section 301 of the FD&C Act (21 U.S.C. 

301). Specifically, the relevant authority 

related to the proposed classification 

includes sections 513(a) through (d) of 

the FD&C Act regarding device classes, 

classification, and panels; section 515 of 

the FD&C Act regarding PMAs; and 

section 701(a) of the FD&C Act (21 

U.S.C. 371(a)). 

D. Costs and Benefits 

If the proposed rule is finalized, 

society may experience welfare gains 

from reductions in AMR due to the rule. 

These welfare gains would be in the 

form of decreased mortality, morbidity, 

and medical costs. Unfortunately, the 

magnitude of these potential benefits is 

difficult to forecast, and we do not 

quantify these impacts in the analysis. 

The quantifiable benefits of the 

proposed rule, if finalized, accrue to 

manufacturers of wound dressings and 

liquid wound washes and FDA. These 

benefits are the result of clarifications in 

the 510(k) submission process, 

specifically defined regulatory 

classification, and published special 

controls. This additional clarity in 

requirements should result in fewer 

additional information submissions to 

FDA. 

We estimate annualized cost savings 

ranging from approximately $1.12 

million to $6.31 million at a 3 percent 

discount rate, and approximately $1.14 

million to $6.42 million at a 7 percent 

discount rate. Our primary annualized 

estimates are approximately $2.66 

million at a 3 percent discount rate and 

$2.71 million at a 7 percent discount 

rate. The primary estimates of the 

present value of total cost savings in the 

10 years following any final rule that 

may be issued based on this proposed 


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8Some products cleared under this product code 

are within scope for this proposed rule and 

proposed classification action. Other products 

under this product code are not within scope of this 

proposed rule and will be addressed via a separate 

classification action. 

9 Ibid. 

10 Ibid. 

11 Ibid. 

12 Ibid. 

rule are $24.55 million at a 3 percent 

rate of discount and $19.02 million at a 

7 percent rate of discount. 

The costs of the proposed rule, if 

finalized, are associated with costs to 

industry for reading and understanding 

the rule, preparing and submitting 

PMAs, and other costs related to the 

PMA process and maintaining the class 

III designation. FDA also incurs costs 

from reviewing PMAs, annual and 

supplemental reports, and inspection 

activities. When annualized over a 

period of 10 years, we estimate these 

costs range from approximately $0.72 

million to $1.25 million at a 3 percent 

discount rate, and approximately $0.65 

million to $1.17 million at a 7 percent 

discount rate. Our primary annualized 

estimates are approximately $0.92 

million at a 3 percent discount rate and 

$0.85 million at a 7 percent discount 

rate. The primary estimates of the 

present value of total costs in the 10 

years following any final rule that may 

be issued based on the proposed rule are 

approximately $7.23 million at a 3 

percent discount rate and $6.48 million 

at a 7 percent discount rate. 

II. Table of Abbreviations/Acronyms 

Commonly Used Acronyms in This 

Document 

Abbreviation/acronym What it means 

510(k) .............................. Premarket Notification. 

AMR ................................ Antimicrobial Resistance. 

CDC ................................ Centers for Disease Control and Prevention. 

CDRH .............................. Center for Devices and Radiological Health. 

CFR ................................. Code of Federal Regulations. 

FD&C Act ........................ Federal Food, Drug, and Cosmetic Act. 

FDA ................................. Food and Drug Administration. 

FRO ................................ The current product code for unclassified, preamendments wound dressings containing antimicrobials and/or other 

chemicals.8

GER ................................ The product code for unclassified, preamendments devices known as external gauze with drug/biologic/animal 

source material.9

MGP ................................ The product code for unclassified, preamendments devices known as occlusive wound and burn dressing.10

MGQ ............................... The product code for unclassified, preamendments devices known as wound and burn hydrogel dressing with drug 

and/or biologic.11

EFQ ................................. The product code for unclassified, preamendments devices known as internal gauze and sponge.12

HHS ................................ Department of Health and Human Services. 

PHMB .............................. Polyhexamethylene Biguanide. 

PMA ................................ Premarket Approval Application. 

OIRA ............................... Office of Information and Regulatory Affairs. 

U.S .................................. United States. 

WHO ............................... World Health Organization. 

III. Background 

A. Need for the Regulation 

Currently, certain solid wound 

dressings; wound dressings formulated 

as a gel, cream, or ointment; and liquid 

wound washes that contain 

antimicrobials and/or other chemicals 

are unclassified devices subject to 

premarket notification (510(k)) under 

section 510(k) of the FD&C Act (21 

U.S.C. 360(k)). Until an unclassified 

device type has been formally classified 

by regulation, and such formal 

classification may or may not require a 

different type of premarket submission 

depending on the classification, 

marketing of new devices within this 

device type requires FDA clearance of a 

510(k). As described below, these 

devices have generally been subject to 

premarket review through the 510(k) 

pathway and have been cleared for 

marketing if their intended use and 

technological characteristics are 

‘‘substantially equivalent’’ to devices 

that were in commercial distribution 

prior to the passage of the Medical 

Device Amendments on May 28, 1976. 

Wound dressings and liquid wound 

washes subject to this proposed rule and 

classification action can be 

subcategorized into three broad 

categories based on their physical form, 

including: (1) solid wound dressings; (2) 

gels, creams, or ointments; and (3) 

liquid wound washes. Irrespective of 

physical form, these wound dressings 

and liquid wound washes have typically 

been indicated for use on a variety of 

acute (e.g., traumatic wounds, surgical 

wounds, etc.) and chronic (e.g., venous 

stasis ulcers, diabetic foot ulcers, 

arterial ulcers, etc.) wounds. Solid 

wound dressings have also been cleared 

with uses such as to provide or support 

a moist wound environment, absorb 

wound exudate, and protect against 

external contamination. Wound gels, 

ointments, and creams have been 

cleared to provide or support a moist 

wound environment. Liquid wound 

washes have been cleared to rinse or 

irrigate a wound and to remove foreign 

material, such as debris and wound 

exudate. Refer to table 1 for a tabular 

overview of the wound dressings and 

liquid wound washes within the scope 

of this proposed classification action. 


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13FDA Premarket Approval, Integra Omnigraft 

Dermal Regeneration Matrix, https://

www.accessdata.fda.gov/scripts/cdrh/cfdocs/ 

cfpma/pma.cfm?id=P900033S042. 14 Drugs at FDA, Silver Sulfadiazine Cream, 

https://www.accessdata.fda.gov/drugsatfda_docs/ 

label/2016/017381s053lbl.pdf. 15FDA Premarket Approval, OrCelTM (Bilayered 

Cellular Matrix), https://www.accessdata.fda.gov/ 

scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010016. 

16Coresistance occurs when there are different 

resistance determinants present on the same genetic 

element. Cross-resistance occurs when the same 

genetic determinant is responsible for resistance to 

multiple types of antimicrobials, such as antibiotics 

and metals. See Baker-Austin C., M. Wright, R. 

Stepanauskas, et al., ‘‘Co-Selection of Antibiotic 

and Metal Resistance,’’ Trends in Microbiology, 

14(4), 2006. Available at https://www.cell.com/ 

trends/microbiology/fulltext/S0966-842X(06)00051- 

5. 

TABLE 1—PROPOSED CLASSIFICATION OF THE WOUND DRESSINGS AND LIQUID WOUND WASHES CONTAINING

ANTIMICROBIALS AND/OR OTHER CHEMICALS

Proposed classification 

Solid wound dressings containing 

antimicrobials and/or other chemicals 

(Proposed new 21 CFR 878.4016) 

Wound dressings formulated as a gel, 

cream, or ointment containing antimicrobials 

and/or other chemicals 

(Proposed new 21 CFR 878.4017) 

Liquid wound washes 

(Proposed new 21 CFR 878.4019) 

Class III (Proposing to require the filing of a 

PMA).

Products containing medically important 

antimicrobials acting as protectants (Proposed § 878.4016(b)(1)).

Products containing medically important 

antimicrobials acting as preservatives 

(Proposed § 878.4017(b)(1)).

Products containing medically important 

antimicrobials acting as preservatives 

(Proposed § 878.4019(b)(1)). 

Class II (Special Controls 

+ General Controls) 

Subject to 510(k) Requirements.

Products containing antimicrobials acting as 

protectants with a medium or low level of 

AMR concern, and/or other chemicals 

(Proposed § 878.4016(b)(2)).

Products containing antimicrobials acting as 

preservatives with a medium or low level 

of AMR concern, and/or other chemicals 

(Proposed § 878.4017(b)(2)).

Products containing antimicrobials acting as 

preservatives with a medium or low level 

of AMR concern, and/or other chemicals 

(Proposed § 878.4019(b)(2)). 

Outside of the scope for this 

rulemaking, FDA has previously 

classified certain wound dressings 

(which have similar intended uses as 

the products in scope for this proposed 

rule, but do not contain antimicrobials 

or other chemicals) as class I and 

exempt from 510(k) requirements (see 

21 CFR 878.4014, 878.4018, 878.4020, 

and 878.4022). FDA has also previously 

determined wound dressings intended 

to accelerate the normal rate of wound 

healing that serve as a replacement for 

full-thickness skin grafting (e.g., 

artificial skin substitute) or treat fullthickness (i.e., third degree) burns to be 

class III medical devices. An example of 

a class III wound dressing is the Integra 

Omnigraft Dermal Regeneration Matrix 

that was approved through PMA 

P900033.13 In addition to wound care 

products regulated by Center for Devices 

and Radiological Health (CDRH), the 

Center for Drug Evaluation and Research 

regulates certain drugs used in wound 

care, such as silver sulfadiazine cream 

indicated for the prevention and 

treatment of wound sepsis,14 and the 

Center for Biologics Evaluation and 

Research regulates certain wound care 

products, such as the OrCel Bilayered 

Cellular Matrix composed of human 

allogeneic skin cells (PMA P010016).15

Wound dressings and liquid wound 

washes containing antimicrobials and/ 

or other chemicals play a critical role in 

wound care for patients in the United 

States. Human skin wounds pose 

substantial risks to patients and 

increasing challenges to the U.S. public 

health (Ref. 5). The prevalence rate for 

chronic, nonhealing wounds is ∼2 

percent of the general population (Ref. 

6). This prevalence rate is similar to that 

of heart failure, but unlike heart failure, 

little is known regarding the outcome of 

these patients or the comparative 

effectiveness of the treatment they 

receive (Ref. 7). An aging population 

and its requisite medical interventions, 

the continuing rise in diabetes and 

obesity, and the increase in traumatic 

wounds all translate to large increases 

in skin wounds needing treatment (Refs. 

6 and 8). Patients with the hardest to 

heal wounds include those with 

diabetes, obesity, sickle cell ulcers, 

vasculitis, and scleroderma (Refs. 6 and 

8). 

The cost of wound care in the United 

States alone exceeds $50 billion 

annually (Refs. 9–12). It is estimated 

that chronic, nonhealing wounds affect 

approximately 6.5 million people 

annually in the United States (Ref. 13). 

Often, these wounds become infected, 

interrupting and delaying wound 

healing and leading to increased 

treatment times, suffering, risk of severe 

complications, and expenses (Ref. 14). 

The annual wound care products market 

is expected to reach $22 billion by 2024, 

which demonstrates the magnitude of 

their impact on public health (Ref. 15). 

B. Terminology 

1. Medically Important Antimicrobial 

For the purposes of this proposed rule 

and this classification action, the term 

‘‘medically important’’ antimicrobial 

refers to an antimicrobial drug that is 

important for therapeutic use in humans 

(Ref. 16). Table 1 of the WHO’s 2018 

publication entitled ‘‘Critically 

Important Antimicrobials for Human 

Medicine: 6th Edition’’ (Ref. 4) has a list 

of all classes of medically important 

antimicrobials. For the purposes of this 

proposed rule and classification action, 

an antimicrobial is considered 

medically important if, and only if, it 

falls within any of these classes 

regardless of the level of importance 

specified by the WHO (i.e., critically 

important, highly important, or 

important). 

2. High, Medium, and Low AMR 

Concern 

For the purposes of this proposed rule 

and this classification action, the level 

of AMR concern has been defined based 

on the following antimicrobial 

characteristics: 

• High-level of AMR concern results 

from wound dressings and liquid 

wound washes that contain a medically 

important antimicrobial as these 

products may directly contribute to the 

development and spread of organisms in 

the patient that are resistant to 

medically important antimicrobials, 

potentially further limiting a clinician’s 

therapeutic options. 

• Medium-level AMR concern results 

from wound dressings and liquid 

wound washes that contain a 

nonmedically important antimicrobial 

which may indirectly select for 

organisms with medically important 

antimicrobial resistance mechanisms via 

coselection mechanisms such as 

coresistance and cross-resistance.16

• Low-level AMR concern results 

from wound dressings and liquid 

wound washes that contain a 

nonmedically important antimicrobial 

which lacks the ability to coselect for 

organisms with medically important 

antimicrobial resistance mechanisms. 

As microbial resistance mechanisms are 

constantly evolving, the categorization 

of low level of AMR concern for a 

particular antimicrobial may be 

upgraded to a medium level of AMR 

concern based on future emerging 

resistance information, such as evidence 

of coresistance or cross-resistance to 

medically important antimicrobials. 


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17Based on FDA’s experience, in rare occasions, 

an antimicrobial may be added to a sterile, singleuse amorphous wound dressing as a manufacturing 

aid to reduce bioburden prior to the manufacturing 

of the final, finished device. 

18 Ingredients in the ‘‘wound protectant’’ category 

of ‘‘other chemicals’’ overlap in some cases with 

active ingredients included in the over-the-counter 

(OTC) drug product monograph for ‘‘skin protectant 

drug products,’’ which was codified in 21 CFR part 

347. These provisions now appear in the final order 

for skin protectant drug products under section 

505G of the FD&C Act (21 U.S.C. 355g), which was 

added by the Coronavirus Aid, Relief, and 

Economic Security Act, Public Law 116–136, 134 

Stat. 281 (2020). Orders for OTC monograph drugs 

can be found at https://dps.fda.gov/omuf. Under 

section 3621 of the Food and Drug Omnibus Reform 

Act of 2022, Public Law 117–328, 136 Stat 4459, 

which added section 503(h) to the FD&C Act (21 

U.S.C. 353(h), products meeting the definition of 

‘‘OTC monograph drug’’ under section 744L of the 

FD&C Act (21 U.S.C. 379j–71), including certain 

skin protectants, are deemed to be drugs. When 

intended for marketing in accordance with this 

proposed rule, however, products containing these 

ingredients, which may be included as ‘‘wound 

protectants,’’ would not be considered OTC 

monograph drugs or otherwise considered drug 

constituent parts. Please note that to be considered 

a ‘‘wound protectant’’ in accordance with this 

proposed rule and classification action, an 

ingredient cannot achieve its primary intended 

purpose through chemical action. Products 

containing such ingredients are outside the scope 

of this proposed rule and classification action. 

3. Antimicrobials as Preservatives or 

Protectants 

To be within the scope of this 

proposed rule and classification action, 

antimicrobials could only be included 

within these wound dressings and 

liquid wound washes for two functions 

or roles to support the use of the 

dressing or wash: (1) a preservative or 

(2) a protectant of the product. 

For the purposes of this proposed rule 

and proposed classification action, an 

antimicrobial is considered a 

preservative when added to wound 

dressings formulated as a gel, cream, or 

ointment and liquid wound washes 

solely to prevent or reduce 

contamination or deterioration thereof 

while in its packaging during shelf 

storage.17 This preservative role helps 

maintain product integrity and safety 

throughout a defined shelf life and/or 

use life. A preservative may be included 

in wound dressings formulated as a gel, 

cream, or ointment or liquid wound 

washes when there is a scientific need 

for the inclusion of the preservative. For 

example, preservatives may be needed 

when the product is provided to the 

user nonsterile, or when the product is 

provided as a sterile single-patient, 

multiple-use product which contains a 

preservative to reduce microbial growth 

in the product over a specified period 

after the sterile seal has been broken. In 

these situations, the preservative may be 

used to maintain sufficiently low 

bioburden and to prevent or retard 

deterioration of the product prior to 

application of the wound dressings 

formulated as a gel, cream, or ointment 

or liquid wound washes. 

Antimicrobials that are not used 

solely to support the use of the wound 

dressings formulated as a gel, cream, or 

ointment or liquid wound washes by 

preventing or reducing contamination or 

deterioration thereof while in its 

packaging, or those in which the use is 

not scientifically needed, are not 

considered preservatives for the 

purposes of this proposed rule. As 

discussed later, other uses, such as 

delivery of antimicrobials to the wound, 

suggest an intent for the treatment of 

infection, which is generally achieved 

through chemical action within or on 

the wound and may not fall under 

CDRH’s jurisdiction. Additionally, as 

solid wound dressings are generally 

provided as sterile, single-use products, 

the inclusion of antimicrobial 

preservatives in solid wound dressings 

would not be necessary. 

For the purposes of this proposed rule 

and proposed classification action, an 

antimicrobial is considered a protectant 

when added to a solid wound dressing 

to prevent or reduce contamination or 

deterioration of the dressing while in 

contact with the wound. This protectant 

role supports the use of solid wound 

dressings (i.e., to cover and protect a 

wound, absorb exudate, and maintain 

appropriate moisture balance within the 

wound) throughout a defined use life. A 

protectant may be included in solid 

wound dressings when there is a 

scientific need for the inclusion of the 

protectant (e.g., solid wound dressings 

which may be applied to a wound for 

a period of multiple days and the 

dressing may be susceptible to microbial 

colonization and biofouling). FDA is 

unaware of a clinical need for including 

a protectant in wound dressings 

formulated as a gel, cream, or ointment 

or liquid wound washes, as an 

application of these products is not 

designed to remain on the body for 

sufficient time to justify clinical concern 

with microbial colonization of the 

product. Refer to table 2 for a tabular 

overview of examples of antimicrobials 

that are within the scope of this 

proposed classification action. 

TABLE 2—LIST OF EXAMPLES OF ANTIMICROBIALS * THAT ARE WITHIN THE SCOPE OF THE PROPOSED RULE AND THE

PROPOSED CLASSIFICATION ACTION FOR CERTAIN WOUND DRESSINGS AND LIQUID WOUND WASHES

Antimicrobials with high-level AMR concern * Antimicrobials with medium-level 

AMR concern Antimicrobials with low-level AMR concern 

Polymyxin B ........................................................ Silver ................................................................ Parabens. 

Silver sulfadiazine .............................................. Zinc .................................................................. Hypochlorous acid. 

Bacitracin ............................................................ Copper ............................................................. Peroxide. 

Chlorhexidine ................................................... Polyhexamethylene biguanide (PHMB). 

Benzalkonium chloride ..................................... Iodine. 

* As identified in the WHO’s ‘‘Critically Important Antimicrobials for Human Medicine,’’ Polymyxin B falls within the Polymyxcin class of medically important antimicrobials, Silver sulfadiazine falls within the Sulfonamide class of medically important antimicrobials, and Bacitracin falls within the Cyclic polypeptide class of medically important antimicrobials. 

4. Other Chemicals 

Wound dressings and liquid wound 

washes may contain other chemicals. 

Categories of other chemicals are wound 

protectants, honey, synthetic peptides, 

or botanical extracts. For the purposes 

of this proposed rule and proposed 

classification action, these ingredients 

are grouped as ‘‘other chemicals’’ and 

are only used to contribute to the uses 

of wound dressings and liquid wound 

washes by physical means (see table 3). 

Ingredients that achieve their primary 

intended purposes through chemical 

action would not fall under ‘‘other 

chemicals’’ for purposes of this 

proposed rule and proposed 

classification action and are therefore 

outside its scope. 

• Wound protectants.18 Wound 

dressings may contain wound 

protectants that provide a physical 

barrier to the external environment and 

help maintain moisture balance within 

the wound. 


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• Honey. Wound dressings may 

contain honey, which helps maintain 

moisture balance within the dressing. 

• Synthetic Peptides. Wound 

dressings may include synthetic 

peptides, which are used to create a 

fibrous scaffold and provide physical 

structure to the wound dressing. 

• Botanical extracts. Wound 

dressings may contain botanical 

extracts, which have such uses as to 

help maintain moisture balance within 

the dressing (e.g., as moisturizers, 

humectants, or emollients) and 

contribute to the physical structure of 

the dressing (e.g., as thickeners, 

emulsifiers, or stabilizers). A botanical 

extract is often a complex mixture of 

vegetable matter obtained from plants, 

algae, macroscopic fungi, and/or 

combinations of these species. For the 

purposes of this proposed rule, plantderived materials that are highly 

purified (e.g., cellulose) or wellcharacterized (e.g., cotton) are not 

considered as other chemicals. 

TABLE 3—CATEGORIES AND EXAMPLES OF OTHER CHEMICALS THAT ARE WITHIN THE SCOPE OF THE PROPOSED RULE

AND THE PROPOSED CLASSIFICATION ACTION FOR CERTAIN WOUND DRESSINGS

Categories of other 

chemicals Examples of other chemicals 

Wound Protectants ........ Petrolatum, mineral oil, cod liver oil, white petrolatum, lanolin, glycerin, dimethicone, lanolin, allantoin, zinc oxide, aluminum hydroxide, calamine, sodium bicarbonate, zinc acetate, zinc carbonate. 

Honey ............................. Manuka honey, buckwheat honey. 

Synthetic Peptides ......... RADA16 (RADARADARADARADA) peptide, self-assembling peptides. 

Botanical Extracts .......... Olive oil, grape seed extract, aloe, lavender, tea tree oil, vegetable oil, shea butter, sesame oil. 

5. Animal-Derived Materials 

Solid wound dressings, wound 

dressings formulated as a gel, cream, or 

ointment, and liquid wound washes 

may also contain animal-derived 

materials. Generally, these animalderived dressing materials are 

degradable, but may also contain 

nondegradable materials. This proposed 

rule excludes wound dressings and 

liquid wound washes containing 

animal-derived materials without the 

presence of antimicrobials or other 

chemicals, as these products are 

currently regulated as a distinct category 

under the product code KGN. More 

information regarding the categories of 

wound dressings and liquid wound 

washes that are outside the scope of this 

rulemaking is included in Section V.A 

Scope/Applicability of this proposed 

rule. 

6. Antimicrobial Resistance 

In the past century, the discovery and 

implementation of medically important 

antimicrobials (e.g., antibiotics) have 

revolutionized modern medicine, 

making once lethal infections readily 

treatable and extending the average 

human lifespan by 23 years (Ref. 17). 

Unfortunately, we now live in an era 

when people are dying from untreatable 

infections because of the emergence and 

spread of AMR—the ability of 

microorganisms (e.g., bacteria and fungi) 

to resist the effects of an antimicrobial. 

The development and spread of AMR 

are widely recognized as a serious 

public health threat. According to the 

U.S. Centers for Disease Control and 

Prevention (CDC), drug-resistant 

bacteria cause more than 35,000 deaths 

and 2.8 million illnesses each year in 

the United States (Ref. 18). In addition 

to the impact on patient morbidity and 

mortality, AMR infections require 

prolonged and costlier treatments, with 

estimates suggesting the U.S. economic 

impact to be around $55 billion per year 

(Ref. 19). 

With a lack of novel antibiotics being 

developed, it is critical to preserve the 

effectiveness of our current 

antimicrobial therapeutic options. Based 

on the 2016 National Quality Partners’ 

‘‘Antibiotic Stewardship in Acute Care: 

A Practical Playbook’’ (Ref. 20), 20 

percent to 50 percent of antibiotics 

prescribed in U.S. acute care hospitals 

are unnecessary or inappropriate, and 

this overuse and misuse of medically 

important antimicrobials have 

contributed to the cultivation of an 

abundance of drug-resistant organisms 

that are becoming increasingly difficult 

to treat. Changes to clinical practice 

patterns to promote appropriate use of 

antimicrobial drugs are essential, and in 

2014, the CDC called on all U.S. 

hospitals to implement antimicrobial 

stewardship programs (Ref. 21) that 

measure and improve how 

antimicrobials are prescribed and used 

by patients. Additionally, public health 

agencies in the Department of Health 

and Human Services, including FDA, 

are engaged in efforts to promote 

antimicrobial stewardship practices to 

maintain a more judicious use of 

antimicrobials and curb the spread of 

AMR (Ref. 22). 

While an antimicrobial is effective 

when applied at an appropriate 

concentration, this effectiveness is only 

exhibited on a limited segment of the 

microbial world. Some species of 

bacteria are naturally resistant to a given 

antimicrobial, while others may 

eventually acquire resistance (e.g., via 

random mutation or acquisition of a 

resistance gene) (Ref. 23). After decades 

of antimicrobial exposure, 

microorganisms have developed a vast 

array of antimicrobial resistance 

mechanisms, including the expression 

of hydrolytic enzymes, activation of 

efflux pump systems, and the alteration 

of cell wall permeability (Ref. 23). Many 

antimicrobial resistance genes are found 

on plasmids, which not only play an 

integral role in the horizontal transfer of 

resistance between organisms, but can 

also stack multiple resistance genes 

together on a single mobile element 

(Ref. 24). As a result, many of today’s 

hospital-acquired infections involve 

bacteria that are resistant to multiple 

classes of antimicrobials, which may 

include both medically important 

antimicrobials along with other broadspectrum antimicrobials (e.g., metals, 

biguanides, quaternary ammonium 

compounds) (Refs. 25 and 26). 

Although all antimicrobial resistance 

is important, additional consideration is 

needed based on the level of importance 

a particular antimicrobial plays in 

human medicine and the availability of 

other therapeutic options to treat or 

mitigate specific infections (Refs. 6, 27– 

29). While medically important 

antimicrobials (e.g., antibiotics) are the 

focal point of antimicrobial stewardship 

practices and resistance classification 

efforts, there are other antimicrobials 

that are routinely utilized in healthcare, 

such as antiseptics (which inhibit or kill 

microorganisms in or on living tissue, 

such as hand washes) and disinfectants 

(which inhibit or kill microorganisms 

on inanimate objects or surfaces) (Ref. 

30). 

Historically, wound dressings and 

liquid wound washes have utilized a 

wide range of antimicrobials as 

preservatives or protectants, each with a 

varying degree of AMR information 


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detailed in the literature. When 

evaluating the level of AMR concern 

associated with antimicrobials used as 

preservatives or protectants in wound 

dressings and liquid wound washes, the 

probable benefit of the wound dressing 

and liquid wound wash should 

outweigh the probable risk of 

contributing to the development and 

spread of resistance, and, particularly, 

resistance to medically important 

antimicrobials. As such, FDA is 

proposing a risk-based approach for 

assessing the level of AMR concern 

(high, medium, or low) associated with 

wound dressings and liquid wound 

washes containing antimicrobials, as 

described in Section III.B Terminology. 

Based on feedback from the 2016 

Panel, a high level of AMR concern is 

associated with the use of medically 

important antimicrobials (e.g., 

antibiotics), as this may present an 

unreasonable risk of illness or injury by 

directly contributing to the selection of 

organisms in the patient that are 

resistant to medically important 

antimicrobials, potentially further 

limiting a clinician’s therapeutic 

options. Likewise, it is important to 

understand and evaluate the potential 

for an antimicrobial to indirectly select 

for organisms with medically important 

antimicrobial resistance mechanisms via 

coselection mechanisms, such as 

coresistance and cross-resistance. 

As antimicrobial resistance is an 

evolving topic with emerging resistance 

mechanisms being routinely developed 

and discovered, this risk-based 

approach provides the flexibility needed 

to address changes in future 

antimicrobial utility and the expanding 

AMR landscape. Classifying these 

wound dressings and liquid wound 

washes will provide clarity and 

transparency regarding the regulatory 

requirements (e.g., general controls, 

special controls, or premarket approval) 

necessary to provide a reasonable 

assurance of safety and effectiveness. As 

antimicrobial resistance remains a 

priority for FDA, such an effort will 

further enhance our ongoing activities 

related to slowing the development of 

AMR to help ensure safe and effective 

use of antimicrobials in wound 

dressings and liquid wound washes 

intended for human use. 

C. FDA’s Current Regulatory Framework 

The FD&C Act (21 U.S.C. 301 et seq.), 

as amended by the Medical Device 

Amendments of 1976 (1976 

amendments) (Pub. L. 94–295), 

established a comprehensive system for 

the regulation of medical devices 

intended for human use. Section 513 of 

the FD&C Act (21 U.S.C. 360c) 

established three classes of devices, 

reflecting the regulatory controls needed 

to provide reasonable assurance of their 

safety and effectiveness: class I (general 

controls), class II (general controls and 

special controls), and class III 

(premarket approval and general 

controls). 

Section 513(a)(1) of the FD&C Act 

defines the three classes of devices. 

Class I devices are those devices for 

which the general controls of the FD&C 

Act (controls authorized by or under 

sections 501, 502, 510, 516, 518, 519, or 

520 of the FD&C Act (21 U.S.C. 351, 

352, 360, 360f, 360h, 360i, or 360j) or 

any combination of such sections) are 

sufficient to provide reasonable 

assurance of safety and effectiveness, or 

those devices for which insufficient 

information exists to determine that 

general controls are sufficient to provide 

reasonable assurance of safety and 

effectiveness or to establish special 

controls to provide such assurance, but 

because the devices are not purported or 

represented to be for a use in supporting 

or sustaining human life or for a use 

which is of substantial importance in 

preventing impairment of human 

health, and do not present a potential 

unreasonable risk of illness or injury, 

are to be regulated by general controls 

(section 513(a)(1)(A) of the FD&C Act). 

Class II devices are those devices for 

which general controls by themselves 

are insufficient to provide reasonable 

assurance of safety and effectiveness, 

but for which there is sufficient 

information to establish special controls 

to provide such assurance, including the 

promulgation of performance standards, 

postmarket surveillance, patient 

registries, development and 

dissemination of guidelines (including 

guidelines for the submission of clinical 

data in premarket notification 

submissions in accordance with section 

510(k)), recommendations, and other 

appropriate actions as the Secretary 

deems necessary to provide such 

assurance (section 513(a)(1)(B) of the 

FD&C Act). 

Class III devices are those devices for 

which insufficient information exists to 

determine that general controls (controls 

authorized by or under sections 501, 

502, 510, 516, 518, 519, or 520 of the 

FD&C Act or any combination of such 

sections) and special controls would 

provide a reasonable assurance of safety 

and effectiveness, and are purported or 

represented for a use in supporting or 

sustaining human life or for a use which 

is of substantial importance in 

preventing impairment of human 

health, or present a potential 

unreasonable risk of illness or injury 

(section 513(a)(1)(C) of the FD&C Act). 

Under section 513(d) of the FD&C Act, 

FDA refers to devices that were in 

commercial distribution before the 1976 

amendments as ‘‘preamendments 

devices.’’ FDA classifies these devices 

after the Agency: (1) receives a 

recommendation from a device 

classification panel (an FDA advisory 

committee); (2) publishes the panel’s 

recommendation for comment, along 

with a proposed regulation classifying 

the device; and (3) publishes a final 

regulation classifying the device 

(section 513(d)(1) of the FD&C Act). 

FDA has classified most 

preamendments devices under these 

procedures. 

A person may market a 

preamendments device that has been 

classified into class III through 

premarket notification procedures 

without submission of a PMA until FDA 

issues a final regulation order under 

section 515(b) of the FD&C Act (21 

U.S.C. 360e(b)) requiring premarket 

approval. FDA is also proposing, by 

proposed order published elsewhere in 

this issue of the Federal Register, to 

require the filing of PMAs for such 

devices. 

After the enactment of the 1976 

amendments, FDA undertook to identify 

and classify all preamendments devices 

in accordance with section 513(d) of the 

FD&C Act. As part of this effort, FDA 

has completed the classification process 

to classify four types of wound 

dressings, as class I medical devices: (1) 

nonresorbable gauze/sponge for external 

use at § 878.4014; (2) hydrophilic 

wound dressing at § 878.4018; (3) 

occlusive wound dressing at § 878.4020; 

and (4) hydrogel wound dressing and 

burn dressing at § 878.4022. However, 

wound dressings that contain 

antimicrobials and/or other chemicals 

were not included in these prior actions 

and have not been separately classified 

to date. 

D. History of This Rulemaking 

As described previously, certain solid 

wound dressings; wound dressings 

formulated as a gel, cream, or ointment; 

and liquid wound washes containing 

antimicrobials and/or other chemicals 

are unclassified, preamendments 

devices. These devices have been 

subject to premarket review through a 

510(k) submission and have been 

cleared for marketing if FDA considers 

the device to be substantially equivalent 

to a legally marketed predicate in 

accordance with section 513(i) of the 

FD&C Act. Currently, there are more 

than 500 legally marketed unclassified, 

preamendments wound dressings and 

liquid wound washes containing 

antimicrobials and/or other chemicals 


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which have been cleared through the 

510(k) pathway that would be subject to 

this proposed classification regulation. 

Consistent with the FD&C Act, FDA 

convened the General and Plastic 

Surgery Devices Panel of the Medical 

Devices Advisory Committee and held 

multiple meetings regarding the 

classification of wound dressings on: (1) 

November 27, 1998 (Ref. 1); (2) August 

25 and 26, 2005 (Ref. 2); and (3) 

September 20 and 21, 2016 (Ref. 3). 

From these meetings, and FDA’s 

research and findings, the Agency 

understands that wound dressings and 

liquid wound washes containing 

medically important antimicrobials pose 

more AMR risk than other wound 

dressings and liquid wound washes. 

Elsewhere in this issue of the Federal 

Register, FDA is proposing to classify 

unclassified, preamendments wound 

dressings and liquid wound washes 

containing medically important 

antimicrobials into class III. FDA is 

proposing this classification as FDA 

believes that insufficient information 

exists to determine that general controls 

and special controls would provide 

reasonable assurance of the safety and 

effectiveness of these devices and these 

devices present a potential unreasonable 

risk of illness or injury. The proposed 

rule would also establish the 

identification, classification, and 

regulatory controls for certain solid 

wound dressings; wound dressings 

formulated as a gel, cream, or ointment; 

and liquid wound washes that contain 

antimicrobials and/or other chemicals. 

1. 1998 General and Plastic Surgery 

Devices Panel 

On November 27, 1998, FDA 

convened the General and Plastic 

Surgery Devices Panel (the 1998 Panel) 

to discuss the classification of five 

wound dressing categories and the 

reclassification of topical oxygen 

chambers for extremities (Ref. 1). At the 

meeting, FDA presented the following 

five types of unclassified, 

preamendments wound dressings for 

the 1998 Panel’s classification 

recommendations: (1) nonresorbable 

gauze/sponges for external use; (2) 

hydrophilic wound dressings; (3) 

occlusive wound dressings, (4) hydrogel 

wound dressings; and (5) porcine 

wound dressings. FDA requested the 

1998 Panel consider the proposed 

classifications for each of these wound 

dressings, including the product 

description and intended uses that 

should be included in the classification 

regulation for each dressing. FDA also 

requested the 1998 Panel discuss the 

risks to health for each dressing. FDA 

asked the 1998 Panel, as part of their 

deliberations, to consider the potential 

risk of viral transmission posed by 

porcine wound dressings. 

The 1998 Panel unanimously 

concurred with a recommendation that 

all five identified wound dressings be 

classified in class I. The 1998 Panel also 

recommended that four of the five 

dressings: (1) nonresorbable gauze/ 

sponges for external use; (2) hydrophilic 

wound dressings; (3) occlusive wound 

dressings; and (4) hydrogel wound 

dressings, be classified as exempt from 

premarket notification requirements. 

Subsequently, FDA classified these four 

dressing types under §§ 878.4014, 

878.4018, 878.4020, and 878.4022, 

respectively (Ref. 4). Therefore, since 

these four dressings were previously 

classified, they are outside the scope of 

this proposed rule and will not be 

discussed further in this proposed rule. 

The fifth dressing type, porcine wound 

dressings, remained unclassified 

following the 1998 Panel meeting. 

Although the 1998 Panel 

recommended that porcine wound 

dressings should be class I, the 1998 

Panel believed that porcine wound 

dressings should not be exempt from 

premarket notification requirements due 

to concerns of potential viral 

contaminants and infectious diseases. 

Since FDA believes the risks of porcine 

wound dressings identified at the 1998 

Panel meeting are also relevant to the 

wound dressings composed of animalderived materials described in this 

proposed rule, a brief summary of the 

1998 Panel discussion on porcine 

wound dressings is provided here. After 

considering the information provided by 

FDA, the open discussions during the 

1998 Panel meeting, and the 1998 Panel 

members’ experiences with these 

wound dressings at that time, the 1998 

Panel provided reasons in support of its 

recommendation for classifying porcine 

wound dressings used to provide or 

support a moist wound environment, to 

cover a wound, to absorb exudate, and/ 

or to minimize fluid loss into class I, not 

exempt from premarket notification 

requirements. 

2. 2005 General and Plastic Surgery 

Devices Panel 

On August 25 and 26, 2005, the 

General and Plastic Surgery Devices 

Panel (the 2005 Panel) met to provide 

advice and recommendations on the 

classification of five unclassified 

preamendments medical devices: (1) 

bone wax; (2) medical maggots; (3) 

medicinal leeches; (4) tissues 

expanders; and (5) wound dressings 

containing antimicrobials and/or other 

chemicals; however, for the purposes of 

this proposed rule, only the 2005 

Panel’s recommendations regarding 

wound dressings containing 

antimicrobials and/or other chemicals 

will be discussed (Ref. 2). At the 2005 

Panel meeting, FDA proposed to 

describe the intended uses for these 

wound dressings containing 

antimicrobials and/or other chemicals, 

whether sterile or nonsterile, as being 

used to cover a wound, to absorb 

exudate, to provide or support a moist 

environment within the dressing, and to 

control bleeding or fluid loss. These 

wound dressings consist of 

nonabsorbable materials and contain 

added antimicrobials and/or other 

chemicals. 

The 2005 Panel unanimously 

concurred to recommend that FDA 

classify wound dressings containing 

antimicrobials and/or other chemicals 

as class II medical devices requiring a 

510(k) submission, subject to special 

controls. Some of the major risks 

identified by the 2005 Panel included 

the possibility that the antimicrobials 

and/or other chemicals could contribute 

to antimicrobial resistance, could 

sensitize the skin, interfere with wound 

healing, or result in selective 

colonization. But the 2005 Panel agreed 

with FDA that there is sufficient 

information to establish special controls 

that, together with general controls, 

would mitigate the risks to health and 

provide a reasonable assurance of safety 

and effectiveness for these products. 

3. 2016 General and Plastic Surgery 

Devices Panel 

The most recent Panel, held on 

September 20 and 21, 2016 (the 2016 

Panel), met for the purposes of obtaining 

recommendations about the 

classification of products, including: (1) 

solid wound dressings; (2) wound 

dressings formulated as a gel, cream, or 

ointment; and (3) liquid wound washes. 

FDA held the 2016 Panel to obtain input 

on the benefits and risks of wound 

dressings and liquid wound washes that 

contain antimicrobials and/or other 

chemicals, as well as on the clinical 

relevance of certain indications. The 

2016 Panel was asked to recommend to 

FDA whether such wound dressings and 

liquid wound washes that contain 

antimicrobials and/or other chemicals 

should be classified into class III 

(subject to PMA and general controls), 

class II (subject to general and special 

controls), or class I (subject only to 

general controls). The 2016 Panel was 

also asked to discuss the types of 

evidence (including clinical evidence) 

that would be helpful to support certain 

indications, as well as the appropriate 

controls necessary to mitigate the risks 

to health and assure the safety and 


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effectiveness of these types of wound 

dressings and liquid wound washes. 

For each type of wound dressing and 

liquid wound wash, FDA presented the 

proposed risks to health and proposed 

mitigation measures. FDA identified 

risks to health applicable to wound 

dressings and liquid wound washes, 

including adverse tissue reaction, 

delayed wound healing, 

incompatibilities with other therapies, 

increased risk of AMR, infection, 

microbial growth, and product 

degradation. Further, FDA identified 

that additional risks to health applicable 

to solid wound dressings included loss 

of barrier function and retention of 

dressing material in the wound. FDA 

also identified that an additional risk 

applicable to liquid wound washes was 

the inability to remove wound debris. 

Following the 2016 Panel meeting, an 

additional risk to health was identified 

based on emerging reports in the 

literature (Refs. 31–37) regarding the 

understood role that our skin microbiota 

plays in the wound healing cascade. As 

such, antimicrobials that leach from 

wound dressings may inadvertently 

negatively impact the patient’s skin 

microbiota in the periwound area 

resulting in impaired wound healing. 

FDA presented information on the 

proposed mitigation measures for the 

risks to health of these wound dressings 

and liquid wound washes, which 

included biocompatibility, in vivo 

evaluation, clinical evaluation of 

dressings for specific intended uses and 

indications for use, labeling, evaluation 

and identification of any probable risk 

and mechanisms for AMR, sterilization 

and shelf-life validation, preservative 

effectiveness testing, and antimicrobial 

effectiveness testing. In addition to 

these identified mitigation measures, 

FDA proposed that the risk of loss of 

barrier function associated with solid 

wound dressings could be mitigated 

through microbial barrier effectiveness 

testing and water loss/moisture barrier 

effectiveness testing. Similarly, FDA 

proposed that the risk of inability to 

remove wound debris and foreign 

materials associated with liquid wound 

washes could be mitigated through 

appropriate bench performance testing. 

Regarding the understood risk that 

antimicrobials may inadvertently 

negatively impact the skin microbiota in 

the periwound area and impair wound 

healing, FDA proposes that this risk 

may be mitigated through antimicrobial 

characterization, performance testing, 

and labeling. 

Regarding the benefit and risk 

assessments, the 2016 Panel noted that 

it is important to consider the 

heterogeneity in wound types when 

evaluating whether labeling claims 

represent clinically meaningful benefit 

to patients. For example, a labeling 

claim specifying use for a specific 

amount of time may be highly beneficial 

for dressings intended to be placed over 

a central venous catheter, but may not 

be as beneficial for burn wounds. The 

2016 Panel also noted that when 

assessing the benefit-risk profile of a 

product, higher risk may be tolerated 

when known benefit is high, whereas 

lower risk should be tolerated when 

known benefit is low or not established. 

Regarding factors to consider when 

more than one antimicrobial is included 

in a single product, the 2016 Panel 

stated that it would be important to 

evaluate whether use of multiple 

antimicrobials in a single product 

would produce antagonistic, synergistic, 

or additive effects with respect to 

reducing bioburden and/or promoting 

AMR. The 2016 Panel noted that it is 

currently not well understood how the 

inclusion of more than one 

antimicrobial would impact the 

likelihood of developing AMR. When 

certain antimicrobials are used together, 

there is surveillance data that shows 

that the risk of selecting for resistance 

is higher. However, the 2016 Panel 

noted that sufficient surveillance data 

does not exist for many other groupings 

of antimicrobials. 

For solid wound dressings, a majority 

of the 2016 Panel members 

recommended that these products be 

classified into class II, subject to special 

controls, with the exception of certain 

solid wound dressings containing 

antimicrobials, such as antibiotics (with 

similar consideration to antimicrobial 

agents that may select for resistance in 

indirect ways). For these exceptions, 

several members of the 2016 Panel 

recommended that these wound 

dressings be classified into class III, 

with one Panel member noting that 

‘‘antibiotics should be held to an 

extremely high set of standards to prove 

value because of the risk of 

[antimicrobial] resistance]’’. Further, the 

2016 Panel meeting included discussion 

to note that special controls, such as 

testing in an animal model, could not be 

used to evaluate and/or mitigate the risk 

of AMR, supporting the assertion of 

several Panel members that solid wound 

dressings containing antibiotics should 

be classified as class III devices. As 

such, some of the 2016 Panel members 

recommended that the AMR risk posed 

by certain antimicrobials, such as 

antibiotics, could be mitigated through 

the increased controls of the PMA 

regulatory pathway that would be 

applied to these wound dressings as 

class III devices. 

Several of the 2016 Panel members 

stated that additional risks associated 

with solid wound dressings containing 

antimicrobials may include leaching 

and systemic absorption of the 

antimicrobials, delayed wound healing, 

retention of dressing material in the 

wound, and loss of barrier function. 

Regarding mitigation of risks, some 2016 

Panel members stated that bench testing 

could be a potential mitigation measure 

for the risk of retention of dressing 

material in the wound. One Panel 

member added that labeling would be 

an additional mitigation measure for 

loss of barrier function since barrier 

function would be dependent on proper 

application of the wound dressing. The 

risk of leaching and systemic adsorption 

of antimicrobials and/or other chemicals 

is also covered in adverse tissue 

reaction and toxicity. 

For wound dressings formulated as a 

gel, cream, or ointment, a majority of the 

2016 Panel members recommended that 

these products be classified into class II, 

subject to special controls, with the 

exception of certain wound dressings 

formulated as a gel, cream, or ointment 

containing antimicrobials, such as 

antibiotics (with similar consideration 

to antimicrobial agents that may select 

for resistance in indirect ways), for 

which some members of the 2016 Panel 

recommended class III. Several of the 

2016 Panel members referenced the 

prior discussion on solid wound 

dressings, wherein they recommended 

that classification should be stratified by 

the risk of the ingredients within the 

dressing. The reasons certain wound 

dressings formulated as a gel, cream, or 

ointment should be classified as class III 

devices, based on the inclusion of 

certain antimicrobials, such as 

antibiotics, aligned with the rationale 

discussed during the deliberations on 

solid wound dressings. Also, some 2016 

Panel members stated that cumulative 

residual material in the wound could 

present an additional potential risk that 

could be mitigated by specific labeling 

requirements. The risks of systemic 

absorption and topical toxicity were 

also concerning to the 2016 Panel. Some 

2016 Panel members questioned 

whether antimicrobials should be 

included in a gel, cream, or ointment at 

all when there may be physical or nonantimicrobial means to reduce 

bioburden in the product. 

For liquid wound washes, a majority 

of the 2016 Panel recommended that 

these products be classified into class I 

or class II, subject to special controls, 

depending on the toxicity of the 

product, with the exception of certain 

liquid wound washes containing 

antimicrobials, such as antibiotics (with 


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19More detail about the medical device names 

and associated information for the product codes 

listed here is available in the Product Code 

Classification Database, available at https://

www.accessdata.fda.gov/scripts/cdrh/cfdocs/ 

cfPCD/classification.cfm. 

20 87 FR 60691, October 6, 2022. Available at 

https://www.govinfo.gov/content/pkg/FR-2022-10- 

06/pdf/2022-21746.pdf. FDA will add a link to the 

meeting materials once they are publicly available. 

21These dressings are currently regulated under 

product code FRO, but FDA’s intent will be to 

assign a new product code for these wound 

dressings as they are out of the scope of this 

proposed rule and proposed classification action. 

22 Id. 

23The majority of the catheter securement 

dressings with antimicrobials are in scope for this 

proposed rule and proposed classification action. 

Catheter securement dressings containing 

antimicrobials that are intended for reduction or 

prevention of infection are outside the scope of this 

proposed rule. 

24These dressings are currently regulated under 

product code FRO, but FDA’s intent will be to 

assign a new product code for these wound 

dressings, as they are out of scope of this proposed 

rule and proposed classification action. 

25 Id. 

26 Id. 

similar consideration to antimicrobial 

agents that may select for resistance in 

indirect ways), for which some members 

of the 2016 Panel recommended class 

III. To support this opinion on 

classifying liquid wound washes 

containing antimicrobials, such as 

antibiotics, as class III devices, several 

of the 2016 Panel members referenced 

the prior discussion regarding solid 

wound dressings, where it was noted 

that special controls could not mitigate 

the risks posed by these products and 

that classification of these products 

should be stratified based on risk of 

AMR. Some of the 2016 Panel members 

felt that the identified risk of ‘‘inability 

to remove wound debris and foreign 

materials’’ would be better refined as 

‘‘inadequate or possible incomplete 

removal of wound debris and foreign 

materials.’’ The 2016 Panel discussed 

the clinical value of debridement and 

irrigation and questioned the value of 

added agents. There was agreement that 

agents in the liquid wound wash would 

affect the wound directly, and there was 

skepticism regarding whether these 

products should contain antimicrobials 

at all. 

IV. Legal Authority 

The Agency is proposing this 

classification under the authority of 

section 301 of the FD&C Act (21 U.S.C. 

301). Specifically, the relevant authority 

related to the proposed classification 

includes sections 513(a) through (d) of 

the FD&C Act regarding device classes, 

classification, and panels; section 515 of 

the FD&C Act regarding PMAs; and 

section 701(a) of the FD&C Act (21 

U.S.C. 371(a)). 

V. Description of the Proposed Rule 

A. Scope/Applicability 

We are proposing to amend subpart E 

of 21 CFR part 878 by adding § 878.4016 

to classify solid wound dressings 

containing antimicrobials and/or other 

chemicals used to cover and protect a 

wound, to absorb exudate, and to 

maintain appropriate moisture balance 

within the wound; § 878.4017 to classify 

wound dressings formulated as a gel, 

cream, or ointment containing 

antimicrobials and/or other chemicals 

used to maintain appropriate moisture 

balance within the wound; and 

§ 878.4019 to classify liquid wound 

washes used to mechanically irrigate 

and physically remove debris from 

external wounds and to moisten solid 

wound dressings in accordance with 

section 513(d) of the FD&C Act. Please 

note that wound dressings and liquid 

wound washes generally achieve the 

maintenance of a moist wound 

environment through nonchemical 

action (e.g., by acting as a barrier). 

Wound dressings and liquid wound 

washes that achieve the maintenance of 

a moist wound environment through 

chemical action would be outside the 

scope of this proposed rule and may be 

drugs or combination products. For 

information on the classification of 

products as drugs, devices or biological 

products, see the guidance 

‘‘Classification of Products as Drugs and 

Devices and Additional Product 

Classification Issues’’ (Ref. 38). 

Examples of antimicrobials and 

categories and examples of other 

chemicals are identified in tables 2 and 

3, respectively. This proposed 

classification rule applies to certain 

wound dressings and liquid wound 

washes currently regulated under the 

product codes FRO, GER, MGP, MGQ, 

and EFQ. The proposed rule only 

applies to wound dressings and liquid 

wound washes that are for use on 

external cutaneous (skin) wounds. 

The following categories of wound 

dressings are outside the scope of this 

proposed rule and classification action 

because they are currently regulated 

either as a distinct category within the 

product code FRO or under a different 

product code,19 as identified: 

• Wound dressings composed of 

animal-derived materials without the 

presence of antimicrobials and/or other 

chemicals, as they are currently 

regulated under product code KGN. 

• Wound dressings with or without 

an added antimicrobial or biologic (e.g., 

thrombin) that is used to provide 

hemostasis through accelerated blood 

clotting when combined with manual 

compression, as they were discussed in 

October 2022 at a Classification 

Panel.20 21

• Absorbable synthetic wound 

dressings without antimicrobials that 

are intended to degrade and be resorbed 

into the wound.22

• Catheter securement dressings 

containing antimicrobials that are 

intended for reduction or prevention of 

infection (e.g., central line-associated 

bloodstream infection).23 24

• Dressings with topical analgesics, 

such as lidocaine or benzocaine.25

• Dressings with hydrocortisone.26

• Wound dressings used on mucosa, 

such as for oral uses or use in the 

gastrointestinal tract. The following 

categories of wound dressings are 

outside the scope of this proposed rule 

and classification action because FDA 

has previously classified them: 

• Nonresorbable gauze/sponge for 

external use at § 878.4014 (Product 

Codes: MAC, OVR, LZM, NAB, OHO, 

PKD, PXY, PYJ, PYK, PYL); 

• Hydrophilic wound dressing at 

§ 878.4018 (Product Codes: KOZ, MGO, 

NAC); 

• Occlusive wound dressing at 

§ 878.4020 (Product Code: NAD); 

• Hydrogel wound dressing and burn 

dressing at § 878.4022 (Product Codes: 

NAE, OJJ, PXQ); 

• Wound dressing with poly (diallyl 

dimethyl ammonium chloride) 

(pDADMAC) additive at § 878.4015 

(Product Code: NYS). 

(Refs. 39–40) 

B. Device Description 

1. Solid Wound Dressings Containing 

Antimicrobials and/or Other Chemicals 

Solid wound dressings containing 

antimicrobials and/or other chemicals 

are used to cover and protect a wound, 

to absorb exudate, and to maintain 

appropriate moisture balance within the 

wound (see intended uses in section 

V.B). The antimicrobials (see table 2) 

contained in solid wound dressings are 

used as a protectant to prevent or reduce 

contamination or deterioration of the 

dressing while in contact with the 

wound. A solid wound dressing may 

contain one or more of the 

antimicrobials (see table 2) and/or other 

chemicals (see table 3). Such a wound 

dressing may also contain animalderived materials (e.g., collagen, gelatin, 

decellularized extracellular matrix). 

The dressing materials are resorbable 

or nonresorbable, synthetic or naturally 

derived materials (including animalderived materials), which are provided 


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27See definition of combination product in 21 

CFR 3.2(e). 

sterile in a form able to hold structural 

integrity permanently or temporarily. 

Solid wound dressings containing 

antimicrobials and/or other chemicals 

may be in the form of a woven or 

nonwoven fabric pad, foam, or as a 

cross-linked hydrogel that has sufficient 

structural integrity to hold a physical 

form, such as a scaffold or matrix. Some 

wound dressings are multilayered, with 

each layer made of a different solid 

form, such as a four-layered dressing 

with a woven layer, foam layer, 

hydrocolloid layer, and occlusive 

adhesive backing layer. The types of 

materials used in these wound dressings 

generally include polyester, cellulose, 

polyurethane, nylon, poly(vinyl 

alcohol), alginate, cross-linked collagen, 

poly(ethylene glycol), and poly(lacticco-glycolic acid). 

2. Wound Dressings Formulated as a 

Gel, Cream, or Ointment Containing 

Antimicrobials and/or Other Chemicals 

A wound dressing formulated as a gel, 

cream, or ointment containing 

antimicrobials and/or other chemicals is 

used to maintain appropriate moisture 

balance within the wound (see intended 

uses in section V.B). The antimicrobials 

contained in such wound dressings are 

used for preservative purposes to 

maintain shelf life for a nonsterile 

wound dressing or a multiple-use 

wound dressing for single patient use 

only (see table 2). A wound dressing 

formulated as a gel, cream, or ointment 

may contain one or more of the 

antimicrobials (see table 2) and/or other 

chemicals (see table 3). Such a wound 

dressing may also contain animalderived materials. 

The wound dressing materials are 

synthetic or naturally derived materials 

(including animal-derived materials), 

which are provided in an amorphous 

form. Wound dressings formulated as a 

gel, cream, or ointment containing 

antimicrobials and/or other chemicals 

are amorphous and can have high water 

content with thickening agents or 

consist of an oil-water emulsion. These 

products are generally packaged in 

tubes or containers that can be for single 

use only or labeled for multiple use for 

single patient use only after the package 

has been opened. While some wound 

dressings are terminally sterilized and 

labeled for single use, many other 

wound dressings cannot be terminally 

sterilized given the sensitivity of the 

materials to sterilization methods, or 

they may require a preservative for 

multiple-use wound dressings for single 

patient use only. 

3. Liquid Wound Washes 

A liquid wound wash is a water-based 

solution used to mechanically irrigate 

and physically remove debris from 

external wounds. It is also used to 

moisten solid wound dressings to 

maintain appropriate moisture balance 

within the dressing (see intended use(s) 

in section V.B). The antimicrobials 

contained in such liquid wound washes 

are used for preservative purposes to 

maintain shelf life for a nonsterile liquid 

wound wash or a multiple-use liquid 

wound wash for single patient use only 

(see table 2). Some liquid wound 

washes are terminally sterilized and 

labeled for single use, or they may 

require a preservative for multiple-use 

liquid wound washes for single patient 

use only. Liquid wound washes may 

contain one or more of the 

antimicrobials (see table 2) and/or other 

chemicals (see table 3). 

Liquid wound washes are generally 

water- or saline-based liquid solutions. 

They are typically packaged in bottles 

with plain caps or pump sprays and 

may or may not be terminally sterilized. 

Such liquid wound washes may also 

contain animal-derived materials. 

4. Proposed Intended Use(s) 

Based on the collective 

recommendations from the 2005 and 

2016 Panels, FDA’s experience with 

these wound dressings and liquid 

wound washes, and other available 

information, FDA proposes the 

following intended uses for the three 

wound dressing and liquid wound wash 

types discussed in this proposed rule. 

Additionally, since the utilization of 

these wound dressings and liquid 

wound washes is not to treat an 

infection, FDA is proposing that the 

intended uses for these wound dressings 

and liquid wound washes remain the 

same whether the product is used for an 

infected or noninfected wound because 

the role of the antimicrobial is limited 

to acting within the dressing and not on 

the wound itself. The proposed uses are 

the following: 

• Solid Wound Dressings Containing 

Antimicrobials and/or Other Chemicals: 

A solid wound dressing containing 

antimicrobials and/or other chemicals is 

used to cover and protect a wound, to 

absorb exudate, and to maintain 

appropriate moisture balance within the 

wound. 

• Wound Dressings formulated as a 

Gel, Cream, or Ointment Containing 

Antimicrobials and/or Other Chemicals: 

A wound dressing formulated as a gel, 

cream, or ointment containing 

antimicrobials and/or other chemicals is 

used to maintain appropriate moisture 

balance within the wound. 

• Liquid Wound Washes: A liquid 

wound wash is a water-based solution 

used to mechanically irrigate and 

physically remove debris from external 

wounds. It is also used to moisten solid 

wound dressings to maintain 

appropriate moisture balance within the 

dressing. 

Within those intended uses, 

antimicrobials may support the 

intended use through the following 

means: 

• Antimicrobial preservative: An 

antimicrobial preservative is used in 

wound dressings formulated as a gel, 

cream, or ointment or liquid wound 

washes to maintain low bioburden 

while in its packaging during storage to 

improve its shelf life. An antimicrobial 

preservative use is not appropriate for a 

sterile, single-use product. Further, 

preservative effectiveness claims are 

within the scope of this proposed rule 

for the proposed classifications only 

when used for a specified period of use 

for multiple-use wound dressings and 

liquid wound washes for single patient 

only use. 

• Antimicrobial protectant: An 

antimicrobial protectant, when added to 

a sterile, single-use solid wound 

dressing, is intended to support the use 

of the wound dressing by reducing 

degradation or biofouling of the dressing 

while in use. Antimicrobial protectant 

claims are within the scope of this 

proposed rule for the proposed 

classifications only when used for 

reducing microbial growth within the 

solid wound dressing for a specified 

maximum period of clinical use. 

Prior to this proposed rulemaking, 

wound dressings and liquid wound 

washes containing antimicrobials 

intended for wound management were 

generally identified as combination 

products.27 This was because the term 

‘‘wound management’’ could be 

interpreted broadly, encompassing uses 

not only including to cover and protect 

a wound, to absorb exudate, and to 

maintain appropriate moisture balance, 

but also uses such as treatment of 

wounds/wound infection. As discussed 

in more detail below, for a product to 

be within the scope of this proposed 

rulemaking and benefit from the 

proposed classification action, FDA is 

proposing that the term ‘‘wound 

management’’ not be included in the 

product labeling and the product 

labeling be clarified to reflect the 


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28See section 201(h) of the FD&C Act (21 U.S.C. 

321(h))—for the definition of device. For guidance 

on how products are classified as devices, please 

see the guidance ‘‘Classification of Products as 

Drugs and Devices and Additional Product 

Classification Issues’’ (https://www.fda.gov/media/ 

80384/download). 

29 In rare cases, antimicrobials can be included as 

a process control to reduce bioburden during 

manufacturing, and this should be supported with 

proper justification and discussed with the review 

team. No performance claims should be made 

regarding the use of antimicrobials as 

manufacturing process controls. 

explicit uses described above (e.g., ‘‘to 

protect and cover a wound’’). 

FDA has considered the intended use 

of these products in this category 

limited to the uses expressly discussed 

above (including to cover and protect a 

wound, to absorb exudate, to maintain 

appropriate moisture balance, to 

mechanically irrigate). However, with 

the inclusion of ‘‘wound management’’ 

and based on feedback during the 2016 

Panel (Ref. 3), these limited intended 

uses were not clear to all users and, 

thus, created a broader objective intent. 

Within the scope of this proposed rule, 

FDA is making manufacturers aware 

that, for their products to be within the 

scope of this proposed rulemaking and 

benefit from the proposed classification 

action, manufacturers must clarify their 

labeling to not include ‘‘management’’ 

but instead explicitly include the 

relevant uses described above. 

Otherwise, the product could be subject 

to a different type of marketing 

authorization, depending on the product 

claims. In many cases, refinement of the 

indications will require revisions to the 

labeling. 

FDA believes that, with such 

clarification of statements in the 

labeling and the indications, wound 

dressings and liquid wound washes in 

this category, including those with 

appropriate amounts of antimicrobial, 

should be regulated only as ‘‘devices’’ 

and not as combination products. This 

is because the antimicrobial, when 

included in a product that only covers 

and protects a wound, absorbs exudate, 

irrigates a wound, and/or maintains 

appropriate moisture balance would not 

achieve its primary intended purpose 

through chemical action within or on 

the body of man.28

Manufacturers who do not intend to 

update their products’ labeling to clarify 

such claims (i.e., update to remove 

wound management and other 

misleading claims discussed below) 

would not be in compliance with the 

special controls when the rule is 

finalized. Hence, these manufacturers’ 

products could be subject to submission 

of their wound dressing or liquid 

wound wash to FDA for review via a 

different type of marketing 

authorization, depending on the product 

claims. For example, wound dressings 

containing antimicrobials that make 

certain wound management claims may 

be considered combination products or 

drugs and regulated as such. 

FDA proposes that the following 

labeling claims are not appropriate for 

the wound dressings and liquid wound 

washes proposed for classification in 

this proposed rule as these claims may 

be unclear or misleading or indicate an 

objective intent outside of the intended 

uses discussed above. While some of 

these uses may have been previously 

reviewed in submissions for wound 

dressings and liquid wound washes 

within the scope of this rule, FDA is 

proposing to clarify, consistent with the 

recommendations of the 2005 and 2016 

Panels and FDA’s experience with these 

dressings and washes, that such uses are 

inappropriate for the wound dressings 

and liquid wound washes being 

proposed for classification through this 

rulemaking. These uses include the 

following: 

• Wound Management: While the 

term has been widely used, it is not 

consistently used and is unclear from a 

clinical perspective. Based on the 2016 

Panel discussion, the Panel members 

agreed that specific functions of wound 

dressings and liquid wound washes had 

clear benefits, including covering and 

protecting a wound, keeping the 

dressing moist, and washing or 

irrigating a wound. Although the term 

‘‘wound management’’ was presented as 

a typical part of the indications and 

intended use of wound dressings and 

liquid wound washes, the 2016 Panel 

members acknowledged that there was 

not a consistent or frequent use of the 

term ‘‘wound management’’ in 

describing how the products are used. 

The 2016 Panel members questioned 

whether the wound dressings and liquid 

wound washes are intended to treat the 

wound or to achieve wound healing. 

Therefore, consistent with the 2016 

Panel’s feedback, this proposed 

rulemaking is clarifying that the term 

‘‘wound management’’ be replaced with 

the specific functions of the wound 

dressing and liquid wound washes (e.g., 

cover and protect the wound in the case 

of solid wound dressings). 

• Use of the word ‘‘may’’ (e.g., ‘‘may 

reduce the risk of infection’’): The word 

‘‘may’’ is ambiguous and could mislead 

the end users when describing a specific 

use (e.g., ‘‘may reduce the risk of 

infection’’); instead, intended uses, 

indications, and claims should be 

clearly stated and supported by 

appropriate data. This is supported by 

the fact that the 2016 Panel discussed 

whether the term ‘‘may reduce the risk 

of infection’’ represented a clinically 

meaningful benefit to the patient, and 

noted that such a claim does not appear 

to be meaningful and is likely confusing 

to patients. 

• Treatment of or cure for wounds: 

This use is for wound healing through 

active interaction with the wound. Such 

a use falls within the scope of product 

codes MGR or MDD, which are 

regulated as a postamendments class III 

device, subject to PMA. 

• Deliver antimicrobials to the 

wound: Such use suggests an intent for 

the treatment or prevention of infection 

that generally would be achieved 

through chemical action within or on 

the wound and may not fall under 

CDRH’s jurisdiction. For the purposes of 

this classification action, the role of the 

antimicrobial(s) is limited to acting 

within the wound dressing or liquid 

wound wash as either a preservative or 

a protectant of the product. 

• Antimicrobial preservative claims 

for a sterile, single-use product: Use of 

a preservative in this context is limited 

only to nonsterile, single-use or 

multiple-use wound dressings for single 

patient use only.29

FDA encourages sponsors to consider 

the following in support of their 

proposed intended use(s) when 

demonstrating they fall within the scope 

of this proposed rule and classification 

action. 

• Preservative effectiveness claims for 

wound dressings formulated as a gel, 

cream, or ointment, and liquid wound 

washes should be defined for a specified 

period of shelf storage, and supported 

by appropriate in vitro testing as 

outlined in USP <51> ‘‘Antimicrobial 

Effectiveness Testing,’’ including 

following specific recommendations 

concerning test organisms and 

acceptance criteria. 

• Antimicrobial effectiveness claims 

for solid wound dressings should 

describe the general level of 

effectiveness (i.e., reduced microbial 

growth within the solid dressing or 

barrier to microbial penetration through 

a solid dressing over a specified period 

of use) and should be supported by in 

vitro test results from a broad selection 

of representative clinically relevant 

microbial species, as described in the 

proposed performance testing special 

controls identified in section V.B. 

However, due to the genetic diversity 

within the different microbial species, 

effectiveness claims on product labeling 

should only describe the general level of 

effectiveness, without listing specific 


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30Only the product code FRO was queried for the 

recall analysis, as the majority of the products in 

scope for this proposed rule fall within FRO. The 

types of recalls reported within FRO are expected 

to be representative of all products in scope for this 

proposed rule. 

test organisms, species, or strains 

(including drug resistant strains such as 

Methicillin-resistant Staphylococcus 

aureus). 

• Antimicrobial effectiveness claims 

for solid wound dressings should 

clearly distinguish the types of data 

used to support the claim; for example, 

whether the claim is based on results 

from in vitro testing, in vivo testing, or 

supporting clinical data. For claims that 

are solely supported by in vitro testing, 

the submission and product labeling 

should clearly state that the claims are 

solely based on in vitro testing and that 

clinical studies were not conducted or 

that the clinical benefit has not been 

evaluated. 

• Antimicrobial and preservative 

effectiveness claims for all wound 

dressings containing antimicrobials 

should not state or imply that these 

products have an antimicrobial impact 

on organisms in the wound 

environment since claims regarding 

effectiveness against wound 

microorganisms and biofilms would be 

outside the scope of this proposed rule. 

C. Risks to Health and Public Health 

Benefits 

In evaluating the risks to health 

associated with the use of wound 

dressings and liquid wound washes, 

FDA considered information from the 

1998 Panel, the 2005 Panel, and the 

2016 Panel regarding the classification 

of wound dressings and liquid wound 

washes; the adverse event reports for 

these wound dressings and liquid 

wound washes in FDA’s Manufacturer 

and User Facility Device Experience 

database examined through July 2022; 

and the published scientific literature, 

which is discussed in FDA’s executive 

summary for the 2016 Panel meeting 

(Ref. 3). 

FDA also considered scientific 

literature published since the 2016 

Panel meeting. A contemporary 

literature search was conducted in 

September 2022 and identified eight 

articles (Refs. 41–48) published since 

June 2016 that are relevant to the safety 

and effectiveness of wound dressings 

and liquid wound washes containing 

antimicrobials. In the review of these 

references, the information from the 

contemporary literature analysis is 

consistent with the findings of the prior 

literature analysis presented at the 2016 

Panel meeting. 

FDA also reviewed recalls reported 

under product code FRO from 2003 to 

July 2022.30 There were no recalls for 

solid wound dressings; wound dressings 

formulated as a gel, cream, or ointment; 

or liquid wound washes containing 

medically important antimicrobials 

acting as either protectants or 

preservatives during this same 

timeframe. Out of the 29 recalls 

identified for wound dressings and 

liquid wound washes containing 

medium or low level of AMR concern 

and/or other chemicals, there was 1 

class I recall, 23 class II recalls, and 5 

class III recalls. The reason for the one 

class I recall was potential microbial 

contamination of the product. Reasons 

for class II and class III recalls include 

erroneous device labeling, devices not 

meeting stability specifications, and 

potential sterility breach of the product. 

Based on this information, FDA believes 

the risks to health associated with the 

use of these wound dressings and liquid 

wound washes are those discussed 

below. 

Based on this information, FDA has 

identified the following risks to health 

to the different categories of wound 

dressings and liquid wound washes 

which are within the scope of this 

proposed rule and classification action: 

• Solid Wound Dressings: adverse 

tissue reaction, immunological reaction, 

transmission of pathogens and parasites, 

toxicity, delayed wound healing, 

incompatibilities with other therapies, 

contribution to the spread of AMR, 

infection, microbial growth within the 

product, product degradation during 

stated shelf storage, loss of barrier 

function, retention of dressing material 

in wound, and negatively impacting the 

skin microbiota in the periwound area 

resulting in impaired wound healing. 

• Wound Dressings Formulated as a 

Gel, Cream, or Ointment: adverse tissue 

reaction, immunological reaction, 

transmission of pathogens and parasites, 

toxicity, delayed wound healing, 

incompatibilities with other therapies, 

contribution to the spread of AMR, 

infection, microbial growth within the 

product, product degradation during 

stated shelf storage, and negatively 

impacting the skin microbiota in the 

periwound area resulting in impaired 

wound healing. 

• Liquid Wound Washes: adverse 

tissue reaction, immunological reaction, 

transmission of pathogens and parasites, 

toxicity, delayed wound healing, 

incompatibilities with other therapies, 

contribution to the spread of AMR, 

infection, microbial growth within the 

product, product degradation during 

stated shelf storage, inability to remove 

wound debris and foreign materials, and 

negatively impacting the skin 

microbiota in the periwound area 

resulting in impaired wound healing. 

Below is a brief description of each of 

the identified risks to health: 

• Adverse tissue reaction: Erythema, 

irritation, inflammation of the wound or 

host tissue, immune response, and 

hemolysis can occur as a result of an 

unwanted tissue response associated 

with the materials or leachables/ 

extractables in wound dressings and 

liquid wound washes. 

• Immunological reaction: This can 

result from a device derived from a new 

animal source or protein denaturation/ 

modification due to the manufacturing 

conditions. 

• Transmission of pathogens and 

parasites (e.g., bacteria, mycoplasma, 

fungi, viruses, and other transmissible 

spongiform encephalopathy agents): 

This can result from contaminated 

animal sources, feed, inadequate 

processing, and viral inactivation of the 

animal-derived materials. 

• Toxicity: Local and/or systemic 

toxicity, tissue necrosis, reduced tissue 

viability, and genotoxicity can occur 

due to toxic antimicrobials or other 

chemicals in the wound dressings or 

liquid wound washes, which can result 

in adverse tissue effects, leading to 

toxicity. This also includes allergic 

reaction and sensitization, as 

individuals with known sensitivity to 

the materials in the wound dressings 

and liquid wound washes may 

experience allergic reactions, which 

may be severe depending on the degree 

of sensitivity. 

• Delayed wound healing: 

Cytotoxicity resulting in dead or 

necrotic tissue can delay healing. 

• Incompatibilities with other 

therapies: An undesirable (e.g., 

antagonistic) reaction could occur 

between the materials contained in/on 

the wound dressings or liquid wound 

washes and other therapies applied to 

the wound. 

• Contribution to the spread of AMR: 

Use of antimicrobials in wound 

dressings and liquid wound washes can 

inadvertently select for and cultivate 

antimicrobial resistant organisms in 

patients and further limit a clinician’s 

therapeutic options to treat infections. 

• Infection: Unsafe methods of 

manufacturing processes, such as 

inadequate aseptic processing, 

inadequate packaging and/or product 

storage can result in contaminated 

product that may be a source of 

infection. This risk includes bacterial 

and fungal infections and 

superinfections which may result from 

the use of an antimicrobial-containing 


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wound dressing or liquid wound wash 

that introduces contaminating 

microorganisms to the wound or 

disrupts the natural balance of skin flora 

around the wound. 

• Microbial growth within the 

product: This can occur from 

inadequate sterilization, preservative 

effectiveness failure, unsafe methods of 

manufacturing processes, inadequate 

packaging and/or product storage. This 

can lead to a change in product 

composition or characteristics (e.g., loss 

of tensile strength, change in pH) and 

may also result in infection or adverse 

tissue reaction. 

• Product degradation during stated 

shelf storage: Inadequate packaging and/ 

or inappropriate storage of wound 

dressings or liquid wound washes can 

result in product degradation during 

storage. Product degradation can also 

change the composition or 

characteristics of the product over time 

and lead to patient harm. 

• Retention of dressing material in 

wound: This risk is generally applicable 

to solid wound dressings, which can 

occur due to a loss in solid dressing 

integrity or unintended degradation of 

solid wound dressings. It may also 

occur due to a healthcare provider 

inadvertently leaving material in the 

wound. This can lead to adverse tissue 

reaction, delay in wound healing, or 

infection. 

• Inability to remove wound debris 

and foreign materials: Ineffective 

washing of the wound can occur. Debris 

and foreign material remaining in the 

wound can delay healing or lead to 

infection. This risk is applicable to the 

liquid wound washes containing 

antimicrobials and/or other chemicals. 

• Loss of barrier function: This risk is 

applicable to solid wound dressings 

indicated as barriers to microbial 

penetration through the wound dressing 

(either via mechanical or antimicrobial 

properties). Loss of this barrier function 

can introduce microbial contamination 

from the environment into the wound 

and can lead to delay in wound healing 

or infection. 

• Impact to skin microbiota in the 

periwound area: This risk is applicable 

to each category of antimicrobialcontaining wound dressings. 

Inadvertent leaching of antimicrobials 

away from the dressing may negatively 

impact the skin microbiota in the 

periwound area by reducing the 

presence of beneficial commensal 

microorganisms that play a role in the 

wound healing cascade, resulting in 

impaired wound healing. 

The purported benefits associated 

with the use of wound dressings and 

liquid wound washes that are proposed 

to be classified into either class III or II 

are discussed below. 

In evaluating the benefits associated 

with the use of wound dressings and 

liquid wound washes containing 

antimicrobials and/or other chemicals, 

FDA considered information from the 

1998 Panel, the 2005 Panel, and the 

2016 Panel regarding the classification 

of wound dressings and liquid wound 

washes and the published scientific 

literature, including clinical guidelines 

for wound care, which is discussed in 

FDA’s executive summary for the 2016 

Panel meeting (Ref. 3). Based on this 

information, there appears to be a lack 

of clinical data to demonstrate a clear 

clinical benefit (e.g., improved clinical 

outcomes from the use of antimicrobial 

dressings over non-antimicrobial 

dressings for the prevention or 

treatment of local wound infections or 

to improve wound healing) regarding 

the use of wound dressings and liquid 

wound washes containing 

antimicrobials and/or other chemicals. 

It is generally understood from the 

literature review and discussion with 

the 2016 Panel members that the 

collection of such clinical data has been 

challenging, as a result of many factors 

(e.g., difficulties grouping patients with 

different wound types, lack of controls, 

unclear endpoints, other treatments 

including use of systemic antibacterial 

drugs, exclusion criteria, and 

identifying a sufficient number of 

patients to power these studies). Despite 

the lack of clear clinical data, several 

benefits to wound dressings and liquid 

wound washes containing 

antimicrobials and/or other chemicals 

have been identified, including the 

following: 

• Maintaining a moist wound healing 

environment: Clinical guidelines note 

that a moist wound environment is ideal 

for wound healing. Wound dressings 

can provide this benefit based on their 

ability to absorb and manage wound 

exudate levels. Wound dressings may 

include ingredients that aid in moisture 

management, for example, through 

acting as a humectant to manage 

moisture levels within the dressing or 

forming a barrier to moisture loss. 

• Providing effective barrier to 

environmental contaminants: This 

benefit applies to solid wound dressings 

that utilize either a mechanical barrier 

(e.g., polyurethane film layer) or an 

antimicrobial barrier to eliminate the 

penetration of external microorganisms 

through the dressing and into the 

wound. 

• Reducing microbial growth within 

the dressing: This benefit applies to 

solid wound dressings that utilize an 

antimicrobial to reduce microbial 

growth and colonization of dressings, 

which can reduce soiling and 

degradation of a dressing and extend the 

length of time a dressing may be applied 

before needing to be changed. 

• Extending the shelf life of nonsterile 

and/or multiuse wound dressings: This 

benefit applies to wound dressings 

formulated as a gel, cream, or ointment 

and liquid wound washes that utilize an 

antimicrobial as a preservative to reduce 

microbial growth within the product 

during shelf storage. This helps keep 

dressings from prematurely degrading or 

becoming a source of crosscontamination. 

Finally, it is noted that selection of 

certain wound dressings and liquid 

wound washes is based on wound bed 

characteristics, and due to their 

heterogenous nature, no single wound 

dressing or liquid wound wash is 

suitable for all types of wounds. As 

such, the robust number and diversity of 

wound dressings and liquid wound 

washes currently on the market 

provides an overall benefit of choice for 

healthcare professionals and other end 

users to select wound dressings and 

liquid wound washes that are tailored to 

the wound characteristics of a particular 

patient. 

D. Proposed Classification and FDA’s 

Findings 

1. Level of AMR Concern and Medically 

Important Antimicrobials 

FDA is proposing the following riskbased paradigm for evaluating the level 

of AMR concern (high, medium, or low) 

associated with wound dressings and 

liquid wound washes containing 

antimicrobials discussed in this 

proposed classification rule. The 

proposed paradigm is based on a 

detailed characterization of the 

antimicrobials contained in wound 

dressings and liquid wound washes 

cleared by FDA under product codes 

FRO, GER, MGP, MGQ, and EFQ, and by 

relying on FDA’s experience in this 

area, literature review, the 2005 and 

2016 Panels’ recommendations, and 

other available information. 

To evaluate the level of AMR concern 

and the proposed risk-based paradigm, 

a literature review was conducted to 

identify the following attributes: (1) 

current applications of the 

antimicrobial, (2) known resistance 

mechanisms, (3) if any of the resistance 

genes are plasmid-mediated, (4) 

evidence of potential for coselection of 

medically important antimicrobial 

resistance via mechanisms such as 

coresistance or cross-resistance, and (5) 

known resistant microbial species. FDA 

is proposing to categorize certain wound 


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dressings and liquid wound washes as 

either having a high, medium, or low 

level of AMR concern, which then 

corresponds with the proposed 

classification of the wound dressings 

and liquid wound washes containing 

antimicrobials (as either being in class 

III or class II, based on the criteria in 

section 513(a)(1) of the FD&C Act). 

2. Proposed Classification of Solid 

Wound Dressings Containing 

Antimicrobials and/or Other Chemicals 

(Proposed § 878.4016) 

Based on FDA’s experience with 

certain wound dressings, the collective 

2005 and 2016 Panels’ 

recommendations, and other available 

information, FDA is proposing to 

classify solid wound dressings 

containing medically important 

antimicrobials used as protectants (see 

table 2) into class III when intended to 

be used to cover and protect a wound, 

to absorb exudate, and to maintain 

appropriate moisture balance within the 

wound (proposed § 878.4016(b)(1)). 

These wound dressings may 

additionally contain other chemicals 

(see table 3). FDA is proposing this 

classification as FDA believes that 

insufficient information exists to 

determine that general controls and 

special controls would provide 

reasonable assurance of safety and 

effectiveness for such wound dressings 

and these wound dressings present a 

potential unreasonable risk of illness or 

injury. FDA is also proposing, by 

proposed order published elsewhere in 

this issue of the Federal Register, to 

require the filing of a PMA if these 

wound dressings are classified into class 

III, which will only be finalized if FDA 

classifies such wound dressings as class 

III. 

In proposed § 878.4016(b)(2), FDA is 

proposing to classify solid wound 

dressings containing antimicrobial(s) 

used as protectants with a medium or 

low level of AMR concern (see table 2) 

and/or other chemicals (see table 3) into 

class II (special controls). FDA is 

proposing this action based on the 

determination that general controls 

alone are not sufficient to provide 

reasonable assurance of the safety and 

effectiveness of these wound dressings, 

and there is sufficient information to 

establish special controls to provide 

such assurance. 

The special controls proposed in 

§ 878.4016(b)(2)(i) through (vii) for these 

proposed class II wound dressings 

include performance testing and 

descriptive information, antimicrobial 

characterization and performance 

testing, AMR risk assessment, 

biocompatibility evaluation, risk 

management assessment for animalderived materials and/or botanical 

extracts, labeling, shelf life validation, 

and sterilization validation. 

3. Proposed Classification for Wound 

Dressings Formulated as a Gel, Cream, 

or Ointment Containing Antimicrobials 

and/or Other Chemicals (Proposed 

§ 878.4017) 

Based on FDA’s experience with 

certain wound dressings, the collective 

2005 and 2016 Panels’ 

recommendations, and other available 

information, FDA is proposing to 

classify wound dressings formulated as 

a gel, cream, or ointment containing 

medically important antimicrobials 

used as preservatives (see table 2), into 

class III when intended to maintain 

appropriate moisture balance within the 

wound (proposed § 878.4017(b)(1)). 

These wound dressings may 

additionally contain other chemicals 

(see table 3). FDA is proposing this 

classification as FDA believes that 

insufficient information exists to 

determine that general controls and 

special controls would provide 

reasonable assurance of the safety and 

effectiveness for such wound dressings 

and these wound dressings present a 

potential unreasonable risk of illness or 

injury. FDA is also proposing, by 

proposed order published elsewhere in 

this issue of the Federal Register, to 

require the filing of a PMA if these 

wound dressings are classified into class 

III, which will only be finalized if FDA 

classifies such wound dressings as class 

III. 

In proposed § 878.4017(b)(2), FDA is 

proposing to classify wound dressings 

formulated as a gel, cream, or ointment 

containing antimicrobials used as 

preservatives with a medium or low 

level of AMR concern (see table 2) and/ 

or other chemicals (see table 3) into 

class II (special controls). FDA is 

proposing this action based on the 

determination that general controls 

alone are not sufficient to provide 

reasonable assurance of the safety and 

effectiveness of these wound dressings, 

and there is sufficient information to 

establish special controls to provide 

such assurance. 

The special controls proposed in 

§ 878.4017(b)(2)(i) through (vii) include 

performance testing and descriptive 

information, antimicrobial 

characterization and preservative 

effectiveness testing, AMR risk 

assessment, biocompatibility evaluation, 

risk management assessment for animalderived materials and/or botanical 

extracts, labeling, shelf-life validation, 

and sterilization validation. 

4. Proposed Classification for Liquid 

Wound Washes (Proposed § 878.4019) 

Based on FDA’s experience with 

certain wound dressings and liquid 

wound washes, the collective 2005 and 

2016 Panels’ recommendations, and 

other available information, FDA is 

proposing to classify liquid wound 

washes containing medically important 

antimicrobials used as preservatives (see 

table 2) into class III when intended to 

irrigate the wound and to moisten solid 

wound dressings to maintain 

appropriate moisture balance within the 

dressing (proposed § 878.4019(b)(1)). 

These liquid wound washes may 

additionally contain other chemicals 

(see table 3). FDA is proposing this 

classification as it believes that 

insufficient information exists to 

determine that general controls and 

special controls would provide 

reasonable assurance of safety and 

effectiveness for such liquid wound 

washes and these washes present a 

potential unreasonable risk of illness or 

injury. FDA is also proposing, by 

proposed order published elsewhere in 

this issue of the Federal Register, to 

require the filing of a PMA if these 

liquid wound washes are classified into 

class III, which will only be finalized if 

FDA classifies such liquid wound 

washes as class III. 

In proposed § 878.4018(b)(2), FDA is 

proposing to classify liquid wound 

washes containing antimicrobials used 

as preservatives with a medium or low 

level of AMR concern (see table 2) or 

other chemicals (see table 3) into class 

II (special controls). FDA is proposing 

this action based on the determination 

that general controls alone are not 

sufficient to provide reasonable 

assurance of the safety and effectiveness 

of these liquid wound washes and there 

is sufficient information to establish 

special controls to provide such 

assurance. 

The special controls proposed in 

§ 878.4018(b)(2)(i) through (vii) include 

performance testing and descriptive 

information, antimicrobial 

characterization and preservative 

effectiveness testing, AMR risk 

assessment, biocompatibility evaluation, 

risk management assessment for animalderived materials and/or botanical 

extracts, labeling, shelf-life validation, 

and sterilization validation. 

In addition, if this proposed rule and 

classification is finalized, FDA plans to 

publish a notice in the Federal Register 

announcing its intent to exempt from 

the premarket notification requirements 

liquid wound washes containing water 

or 0.9 percent saline only, which do not 

contain antimicrobials, other chemicals, 


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or animal-derived materials, subject to 

certain limitations. FDA believes that a 

510(k) is not necessary to provide 

reasonable assurance of the safety and 

effectiveness of this wound wash type, 

in accordance with section 510(m) of 

the FD&C Act. 

5. Proposed Special Controls 

Based on the collective 2005 and 2016 

Panels’ recommendations, FDA’s 

experience with these wound dressings 

and liquid wound washes, and other 

available information, FDA is proposing 

the special controls identified in this 

section for wound dressings and liquid 

wound washes that are proposed to be 

classified into class II. FDA believes that 

these special controls, in addition to 

general controls, are necessary to 

provide a reasonable assurance of safety 

and effectiveness of the wound 

dressings and liquid wound washes 

containing antimicrobials used as either 

protectants or preservatives with a 

medium or low level of AMR concern 

(see table 2) and/or other chemicals (see 

table 3). Special controls were discussed 

at the 2016 Panel (Ref. 2, see section 

III.B of the Executive Summary). The 

2016 Panel agreed that the special 

controls as presented would provide a 

reasonable assurance of safety and 

effectiveness for these wound dressings 

and liquid wound washes, emphasizing 

in discussions, among other things, the 

need for adequate labeling, specific use 

claims, and sufficient data to support 

labeling claims. 

As noted in Section V.C Risks to 

Health and Public Health Benefits of 

this proposed rule, three risks 

(specifically, toxicity, transmission of 

pathogens and parasites, and 

immunological reaction) were added as 

separate risks since the 2016 Panel 

meeting, which resulted in changes to 

the corresponding proposed mitigation 

measures for the identified risks to 

health. Additionally, 2016 Panel 

members suggested we consider 

including leaching and systemic 

absorption of antimicrobials or other 

chemicals as risks. These risks are 

included within adverse tissue reaction 

and toxicity and mitigations are 

included to address them. However, 

FDA does not believe these need to be 

added as separate categories of risks to 

health. 

For several of the risks to health, 

additional mitigation measures are 

proposed compared to those identified 

during the 2016 Panel. The proposed 

mitigations are due to the specific 

attributes of the materials of the wound 

dressings and liquid wound washes, 

which require specific mitigation 

measures to address the risks identified 

(e.g., animal-derived materials, 

botanical extracts). The newly proposed 

mitigation measures include 

performance testing and descriptive 

information and a risk management 

assessment for animal-derived materials 

and/or botanical extracts. In addition, 

certain previously proposed mitigation 

measures (e.g., labeling, performance 

data) were recognized to have a role in 

mitigating more risks than initially 

proposed during the 2016 Panel 

meeting. Mitigations have been 

associated with the relevant identified 

risks as subsequently discussed in this 

proposed rule. Following the 2016 Panel 

meeting, an additional probable health 

risk was identified based on reports in 

the literature (Refs. 49–55) regarding the 

understood role that our skin microbiota 

plays in the wound healing cascade. 

As such, antimicrobials that leach 

from wound dressings may 

inadvertently impact the skin 

microbiota in the periwound area 

resulting in impaired wound healing. 

Antimicrobial preservative claims for 

wound dressings formulated as a gel, 

cream, or ointment and liquid wound 

washes; and protectant and microbial 

barrier claims for solid wound dressings 

may be supported by in vitro testing, 

limiting the stated period of 

effectiveness to that supported by 

simulated-use testing parameters, as 

described in the special controls in 

section V.D of this proposed rule. 

FDA believes that the special controls 

proposed for these wound dressings and 

liquid wound washes, in addition to the 

general controls, mitigate the risks to 

health discussed in Section V.C, Risks 

to Health and Public Health Benefits of 

this proposed rule and are necessary to 

provide reasonable assurance of safety 

and effectiveness. Tables 4–6 depict 

how each identified risk to health 

would be mitigated by the proposed 

special controls. 

TABLE 4—IDENTIFIED RISKS TO HEALTH AND PROPOSED MITIGATION MEASURES FOR SOLID WOUND DRESSINGS CONTAINING ANTIMICROBIALS WITH A MEDIUM OR LOW LEVEL OF AMR CONCERN FOR PROTECTANT PURPOSES ONLY

AND/OR OTHER CHEMICALS

Identified risks to health Proposed mitigation measure(s) 

Adverse tissue reaction ............................................................................ • Performance testing and descriptive information. 

• Biocompatibility evaluation. 

• Risk management assessment for the inclusion of animal-derived 

material and/or botanical extracts. 

• Labeling. 

Immunological reaction ............................................................................. • Performance testing and descriptive information. 

• Risk management assessment for the inclusion of animal-derived 

material and/or botanical extracts. 

• Labeling. 

Transmission of pathogens and parasites (e.g., bacteria, mycoplasma, 

fungi, viruses, and other transmissible spongiform encephalopathy 

agents).

• Performance testing and descriptive information. 

• Risk management assessment for the inclusion of animal-derived 

material. 

• Labeling. 

Toxicity ...................................................................................................... • Performance testing and descriptive information. 

• Biocompatibility evaluation. 

• Risk management assessment for the inclusion of animal-derived 

material and/or botanical extracts. 

• Labeling. 

Delayed wound healing ............................................................................ • Performance testing and descriptive information. 

• Biocompatibility evaluation. 

• Labeling. 

Incompatibilities with other therapies ....................................................... • Labeling. 


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TABLE 4—IDENTIFIED RISKS TO HEALTH AND PROPOSED MITIGATION MEASURES FOR SOLID WOUND DRESSINGS CONTAINING ANTIMICROBIALS WITH A MEDIUM OR LOW LEVEL OF AMR CONCERN FOR PROTECTANT PURPOSES ONLY

AND/OR OTHER CHEMICALS—Continued 

Identified risks to health Proposed mitigation measure(s) 

Contribution to the spread of antimicrobial resistance (AMR) ................. • Antimicrobial Characterization and Performance Testing. 

• AMR risk assessment. 

• Labeling. 

Infection .................................................................................................... • Antimicrobial Characterization and Performance Testing. 

• Shelf life validation. 

• Sterilization validation. 

• Risk management assessment for animal-derived materials and/or 

botanical extracts. 

• Labeling. 

Microbial growth within the product during use ....................................... • Antimicrobial Characterization and Performance Testing. 

• Sterilization validation. 

Product degradation during stated shelf storage ..................................... • Shelf life validation. 

• Labeling. 

Retention of dressing material in wound .................................................. • Performance testing and descriptive information. 

• Labeling. 

Loss of Barrier function ............................................................................ • Antimicrobial Characterization and Performance Testing. 

Negatively impacting the skin microbiota in the periwound area resulting in impaired wound healing.• Antimicrobial Characterization and Performance Testing. 

• Labeling. 

TABLE 5—IDENTIFIED RISKS TO HEALTH AND PROPOSED MITIGATION MEASURES FOR WOUND DRESSINGS FORMULATED

AS A GEL, CREAM, OR OINTMENT CONTAINING ANTIMICROBIALS WITH A MEDIUM OR LOW LEVEL OF AMR CONCERN

FOR PRESERVATIVE PURPOSES ONLY AND/OR OTHER CHEMICALS

Identified risks to health Proposed mitigation measure(s) 

Adverse tissue reaction ............................................................................ • Performance testing and descriptive information. 

• Biocompatibility evaluation. 

• Risk management assessment for the inclusion of animal-derived 

material and/or botanical extracts. 

• Labeling. 

Immunological reaction ............................................................................. • Performance testing and descriptive information. 

• Risk management assessment for the inclusion of animal-derived 

material and/or botanical extracts. 

• Labeling. 

Transmission of pathogens and parasites (e.g., bacteria, mycoplasma, 

fungi, viruses, and other transmissible spongiform encephalopathy 

agents).

• Performance testing and descriptive information. 

• Risk management assessment for the inclusion of animal-derived 

material. 

• Labeling. 

Toxicity ...................................................................................................... • Performance testing and descriptive information. 

• Biocompatibility evaluation. 

• Risk management assessment for the inclusion of animal-derived 

material and/or botanical extracts. 

• Labeling. 

Delayed wound healing ............................................................................ • Performance testing and descriptive information. 

• Biocompatibility evaluation. 

• Labeling. 

Incompatibilities with other therapies ....................................................... • Labeling. 

Contribution to the spread of antimicrobial resistance (AMR) ................. • Antimicrobial Characterization and Preservative Effectiveness Testing. 

• AMR risk assessment. 

• Labeling. 

Infection .................................................................................................... • Antimicrobial Characterization and Preservative Effectiveness Testing. 

• Shelf life validation. 

• Sterilization validation. 

• Risk management assessment for animal-derived materials and/or 

botanical extracts. 

• Labeling. 

Microbial growth within the product during storage ................................. • Antimicrobial Characterization and Preservative Effectiveness Testing. 

• Sterilization validation. 

Product degradation during stated shelf storage ..................................... • Shelf life validation. 

• Labeling. 

Negatively impacting the skin microbiota in the periwound area resulting in impaired wound healing.• Antimicrobial Characterization and Performance Testing. 

• Labeling. 


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83792 Federal Register / Vol. 88, No. 229 / Thursday, November 30, 2023 / Proposed Rules 

TABLE 6—IDENTIFIED RISKS TO HEALTH AND PROPOSED MITIGATION MEASURES FOR LIQUID WOUND WASHES CONTAINING ANTIMICROBIALS WITH A MEDIUM OR LOW LEVEL OF AMR CONCERN FOR PRESERVATIVE PURPOSES ONLY, 

AND/OR CONTAINING OTHER CHEMICALS

Identified risks to health Proposed mitigation measure(s) 

Adverse tissue reaction ............................................................................ • Performance testing and descriptive information. 

• Biocompatibility evaluation. 

• Risk management assessment for the inclusion of animal-derived 

material and/or botanical extracts. 

• Labeling. 

Immunological reaction ............................................................................. • Performance testing and descriptive information. 

• Risk management assessment for the inclusion of animal-derived 

material and/or botanical extracts. 

• Labeling. 

Transmission of pathogens and parasites (e.g., bacteria, mycoplasma, 

fungi, viruses, and other transmissible spongiform encephalopathy 

agents).

• Performance testing and descriptive information. 

• Risk management assessment for the inclusion of animal-derived 

material. 

• Labeling. 

Toxicity ...................................................................................................... • Performance testing and descriptive information. 

• Biocompatibility evaluation. 

• Risk management assessment for the inclusion of animal-derived 

material and/or botanical extracts. 

• Labeling. 

Delayed wound healing ............................................................................ • Performance testing and descriptive information. 

• Biocompatibility evaluation. 

• Labeling. 

Incompatibilities with other therapies ....................................................... • Labeling. 

Contribution to the spread of antimicrobial resistance (AMR) ................. • Antimicrobial Characterization and Preservative Effectiveness Testing. 

• AMR risk assessment. 

• Labeling. 

Infection .................................................................................................... • Antimicrobial Characterization and Preservative Effectiveness Testing. 

• Shelf life validation. 

• Sterilization validation. 

• Risk management assessment for animal-derived materials and/or 

botanical extracts. 

• Labeling. 

Microbial growth within the product during storage ................................. • Antimicrobial Characterization and Preservative Effectiveness Testing. 

• Sterilization validation. 

Product degradation during stated shelf storage ..................................... • Shelf life validation. 

• Labeling. 

Inability to remove wound debris and foreign materials .......................... • Performance testing and descriptive information. 

• Labeling. 

Negatively impacting the skin microbiota in the periwound area resulting in impaired wound healing.• Antimicrobial Characterization and Performance Testing. 

• Labeling. 

VI. Proposed Effective/Compliance 

Dates 

FDA proposes that any final rule, 

based on this proposed rule, become 

effective 30 days after its date of 

publication in the Federal Register. 

Below, FDA has laid out a proposed 

tiered approach that we believe will 

help ensure the efficient and effective 

implementation of this classification 

regulation, when finalized. 

A. Devices That Are Proposed To Be 

Classified Into Class III 

For devices proposed to be classified 

into class III in this proposed rule, FDA 

is publishing a proposed order to 

require the filing of a PMA elsewhere in 

this issue of the Federal Register. 

If this proposed rule and related 

proposed order to require the filing of a 

PMA are finalized, wound dressings and 

liquid wound washes that are proposed 

to be classified into class III are 

considered adulterated if a PMA is not 

filed with FDA within 30 months after 

the classification of the device into class 

III, and commercial distribution of the 

product must cease (see section 

501(f)(2)(B) of the FD&C Act (21 U.S.C. 

351(f)(2)(B))). 

Moreover, manufacturers must cease 

distribution of devices upon receiving a 

not approvable or denial decision 

rendered on a PMA. In such 

circumstances, to resume distribution, 

these manufacturers must receive PMA 

approval for their devices. However, the 

product may be distributed for 

investigational use only if the 

requirements of the investigational 

device exemptions regulations in 21 

CFR part 812 are met. 

For currently marketed wound 

dressings and liquid wound washes that 

are proposed to be classified into class 

III, FDA is proposing in the abovementioned proposed order that it does 

not intend to enforce compliance with 

the 30-month deadline by which PMAs 

must be submitted when a notice of 

intent to file a PMA is submitted within 

90 days of the effective date of the order, 

if finalized. In circumstances when a 

notice of intent to file is submitted, FDA 

is proposing that it does not intend to 

enforce compliance with the 30-month 

deadline by which PMAs must be 

submitted when a PMA is submitted 

within 90 days after the 30-month 

deadline. However, as discussed above, 

even if a notice of intent and PMA are 

submitted by these dates, manufacturers 

must cease distribution of devices upon 


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receiving a not approvable or denial 

decision rendered on a PMA. 

B. Devices That Are Proposed To Be 

Classified Into Class II 

• Devices proposed to be classified 

into class II that have not been offered 

for sale prior to the effective date of this 

rule, when finalized, or have been 

offered for sale but are required to 

submit a new 510(k) under 

§ 807.81(a)(3): FDA proposes that before 

marketing these devices, manufacturers 

would have to obtain 510(k) clearance 

(unless exempted from 510(k)), and 

demonstrate compliance with the 

applicable special controls, within 6 

months after the effective date of this 

rule, when finalized. After that date, if 

a manufacturer markets such a device 

without receiving 510(k) clearance, then 

FDA would consider taking action 

against such a manufacturer under its 

usual enforcement policies. 

• Devices proposed to be classified 

into class II that have prior 510(k) 

clearance: FDA proposes that it would 

accept a new 510(k) and would issue a 

new clearance letter, as appropriate, 

indicating substantial equivalence and 

compliance with the special controls. 

These devices could serve as predicates 

for new devices. These clearance letters 

would be made publicly available in 

FDA’s 510(k) database, and compliance 

with special controls at the time of 

clearance would be stated in the 

publicly available 510(k) Summary 

posted in this database. FDA believes 

that our public database is a transparent 

tool allowing consumers to confirm that 

their devices have been submitted under 

a new 510(k) and demonstrate 

compliance with the applicable special 

controls. 

For the devices proposed to be 

classified into class II, subject to special 

controls as described in this proposed 

rule, FDA proposes that the special 

controls become effective 6 months after 

the effective date of the rule, when 

finalized. FDA proposes that if a 

manufacturer markets such a device 6 

months after the effective date of the 

rule, when finalized, and that device 

does not comply with the special 

controls, then FDA would consider 

taking action against such a 

manufacturer under its usual 

enforcement policies. 

VII. Preliminary Economic Analysis of 

Impact 

We have examined the impacts of the 

proposed rule under Executive Order 

12866, Executive Order 13563, 

Executive Order 14094, the Regulatory 

Flexibility Act (5 U.S.C. 601–612), and 

the Unfunded Mandates Reform Act of 

1995 (Pub. L. 104–4). 

Executive Orders 12866, 13563, and 

14094 direct us to assess all benefits, 

costs, and transfers of available 

regulatory alternatives and, when 

regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). Rules 

are ‘‘significant’’ under Executive Order 

12866 Section 3(f)(1) (as amended by 

Executive Order 14094) if they ‘‘have an 

annual effect on the economy of $200 

million or more (adjusted every 3 years 

by the Administrator of the Office of 

Information and Regulatory Affairs 

(OIRA) for changes in gross domestic 

product); or adversely affect in a 

material way the economy, a sector of 

the economy, productivity, competition, 

jobs, the environment, public health or 

safety, or State, local, territorial, or tribal 

governments or communities.’’ OIRA 

has determined that this proposed rule 

is not a significant regulatory action 

under Executive Order 12866, section 

3(f)(1). 

The Regulatory Flexibility Act 

requires us to analyze regulatory options 

that would minimize any significant 

impact of a rule on small entities. 

Because the costs of the proposed rule 

primarily accrue to larger firms, we 

propose to certify that the proposed rule 

will not have a significant economic 

impact on a substantial number of small 

entities. 

The Unfunded Mandates Reform Act 

of 1995 (section 202(a)) requires us to 

prepare a written statement, which 

includes estimates of anticipated 

impacts, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $177 

million, using the most current (2022) 

Implicit Price Deflator for the Gross 

Domestic Product. This proposed rule 

would not result in an expenditure in 

any year that meets or exceeds this 

amount. 

This proposed rule, if finalized, 

would classify certain types of currently 

unclassified wound dressings and liquid 

wound washes containing 

antimicrobials and/or other chemicals: 

solid dressings; wound dressings 

formulated as a gel, cream, or ointment; 

and liquid wound washes. FDA is 

proposing to classify wound dressings 

and liquid wound washes containing 

medically important antimicrobials into 

class III due to their high level of AMR 

concern, for which FDA is separately 

proposing to require the filing of a PMA. 

FDA has determined that general 

controls and special controls together 

are insufficient to provide reasonable 

assurance of safety and effectiveness for 

such wound dressings and liquid 

wound washes. In addition, FDA is 

proposing to classify wound dressings 

and liquid wound washes containing 

antimicrobials with a medium or low 

level of AMR concern into class II 

subject to general and special controls. 

FDA is publishing this proposed rule 

based, in part, on the recommendations 

of the General and Plastic Surgery 

Devices Panel regarding the 

classification of certain types of wound 

dressings and liquid wound washes. 

To estimate costs and benefits 

associated with the proposed rule, if 

finalized, we assume that the 

appropriate baseline is the current state 

of the United States with unclassified 

wound dressings and liquid wound 

washes containing antimicrobials and/ 

or other chemicals. We then compare 

the likely impacts of the proposed rule 

against this baseline. The quantifiable 

benefits of the proposed rule, if 

finalized, accrue to manufacturers of 

wound dressings and liquid wound 

washes and FDA. These benefits are the 

result of clarifications in the 510(k) 

submission process, specifically defined 

regulatory classification, and published 

special controls. This additional clarity 

in requirements should result in fewer 

additional information submissions to 

FDA. 

We estimate annualized cost savings 

ranging from approximately $1.12 

million to $6.31 million at a 3 percent 

discount rate, and approximately $1.14 

million to $6.42 million at a 7 percent 

discount rate. Our primary annualized 

estimates are approximately $2.66 

million at a 3 percent discount rate and 

$2.71 million at a 7 percent discount 

rate. The primary estimates of the 

present value of total cost savings in the 

10 years following any final rule that 

may be issued based on this proposed 

rule are $24.55 million at a 3 percent 

rate of discount and $19.02 million at a 

7 percent rate of discount. If the 

proposed rule is finalized, society may 

experience welfare gains from 

reductions in AMR due to the rule. 

These welfare gains would be in the 

form of decreased mortality, morbidity, 

and medical costs. Unfortunately, the 

magnitude of these potential benefits is 

difficult to forecast, and we do not 

quantify these impacts in the analysis. 

We summarize quantified benefits in 

table 7. 


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The costs of the proposed rule, if 

finalized, are associated with costs to 

industry for reading and understanding 

the rule, preparing and submitting 

PMAs, and other costs related to the 

PMA process and maintaining the class 

III designation. FDA also incurs costs 

from reviewing PMAs, annual and 

supplemental reports, and inspection 

activities. When annualized over a 

period of 10 years, we estimate these 

costs range from approximately $0.72 

million to $1.25 million at a 3 percent 

discount rate, and approximately $0.65 

million to $1.17 million at a 7 percent 

discount rate. Our primary annualized 

estimates are approximately $0.92 

million at a 3 percent discount rate and 

$0.85 million at a 7 percent discount 

rate. The primary estimates of the 

present value of total costs in the 10 

years following any final rule that may 

be issued based on the proposed rule are 

approximately $7.23 million at a 3 

percent discount rate and $6.48 million 

at a 7 percent discount rate. These 

values are summarized in table 7. 

TABLE 7—SUMMARY OF BENEFITS, COSTS, AND DISTRIBUTIONAL EFFECTS OF PROPOSED RULE

Category Primary 

estimate 

Low 

estimate 

High 

estimate 

Units 

Notes Year 

dollars 

Discount 

rate 

(%) 

Period 

covered 

(years) 

Benefits: 

Annualized Monetized $millions/year .................................................... $2.71 

2.66 

$1.14 

1.12 

$6.42 

6.31 

2022 

2022 

7 

3 

10 

10 

Annualized Quantified ........................................................................... ..................

..................

..................

..................

..................

..................

..................

..................

7 

3 

..................

..................

Qualitative ..............................................................................................

Costs: 

Annualized Monetized $millions/year .................................................... 0.92 

0.85 

0.72 

0.65 

1.25 

1.17 

2022 

2022 

7 

3 

10 

10 

Annualized Quantified ........................................................................... ..................

..................

..................

..................

..................

..................

..................

..................

7 

3 

..................

..................

Qualitative ..............................................................................................

Transfers: 

Federal Annualized Monetized $millions/year ....................................... ..................

..................

..................

..................

..................

..................

..................

..................

7 

3 

..................

..................

From/To ................................................................................................. From: To: 

Other Annualized Monetized $millions/year .......................................... 0.30 

0.28 

0.19 

0.18 

0.58 

0.56 

2022 

2022 

7 

3 

10 

10 

From/To ................................................................................................. From: Industry To: FDA 

Effects: 

State, Local, or Tribal Government: None. 

Small Business: None. 

Wages: 

Growth: 

We have developed a comprehensive 

Preliminary Economic Analysis of 

Impacts that assesses the impacts of the 

proposed rule. The full preliminary 

analysis of economic impacts is 

available in the docket for this proposed 

rule (Ref. 56) and at https://

www.fda.gov/about-fda/economicsstaff/regulatory-impact-analyses-ria. 

VIII. Analysis of Environmental Impact 

We have determined under 21 CFR 

25.34(b) that this action is of a type that 

does not individually or cumulatively 

have a significant effect on the human 

environment. Therefore, neither an 

environmental assessment nor an 

environmental impact statement is 

required. 

IX. Paperwork Reduction Act of 1995 

FDA tentatively concludes that this 

proposed rule contains no collection of 

information. Therefore, clearance by the 

Office of Management and Budget under 

the Paperwork Reduction Act of 1995 is 

not required. 

X. Federalism 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. We 

have determined that this proposed rule 

does not contain policies that have 

substantial direct effects on the States, 

on the relationship between the 

National Government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government. Accordingly, we 

conclude that the rule does not contain 

policies that have federalism 

implications as defined in the Executive 

order and, consequently, a federalism 

summary impact statement is not 

required. 

XI. Consultation and Coordination With 

Indian Tribal Governments 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13175. We 

have tentatively determined that the 

rule does not contain policies that 

would have a substantial direct effect on 

one or more Indian Tribes, on the 

relationship between the Federal 

Government and Indian Tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian Tribes. The 

Agency solicits comments from tribal 

officials on any potential impact on 

Indian Tribes from this proposed action. 

XII. References 

The following references marked with 

an asterisk (*) are on display at the 

Dockets Management Staff (see 

ADDRESSES) and are available for 

viewing by interested persons between 


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Federal Register / Vol. 88, No. 229 / Thursday, November 30, 2023 / Proposed Rules 83795 

9 a.m. and 4 p.m., Monday through 

Friday; they also are available 

electronically at https://

www.regulations.gov. References 

without asterisks are not on public 

display at https://www.regulations.gov 

because they have copyright restriction. 

Some may be available at the website 

address, if listed. References without 

asterisks are available for viewing only 

at the Dockets Management Staff. FDA 

has verified the website addresses, as of 

the date this document publishes in the 

Federal Register, but websites are 

subject to change over time. 

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Panel, ‘‘Transcript of the FDA General 

and Plastic Surgery Devices Panel 

meeting—November 17, 1998.’’ 

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20180125235924/https://www.fda.gov/ 

ohrms/dockets/ac/98/transcpt/ 

3483t1.pdf. 

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Panel, ‘‘Brief Summary from the General 

and Plastic Surgery Devices Panel 

Meeting—August 25–26, 2005.’’ 

Available at https://www.fda.gov/ 

AdvisoryCommittees/Committees

MeetingMaterials/MedicalDevices/ 

MedicalDevicesAdvisoryCommittee/ 

GeneralandPlasticSurgeryDevicesPanel/ 

ucm124755.htm. 

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Panel, ‘‘2016 Meeting Materials of the 

General and Plastic Surgery Advisory 

Panel—September 20–21, 2016.’’ 

Available at https://www.fda.gov/ 

AdvisoryCommittees/Committees

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MedicalDevicesAdvisoryCommittee/ 

GeneralandPlasticSurgeryDevicesPanel/ 

ucm518493.htm. 

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6. Nussbaum S., M. Carter, C. Fife, et al., ‘‘An 

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7. Berry C., D.R. Murdoch, and J.J. McMurray, 

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8. Carter M., C. Fife, D. Walker, et al., 

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2009. Available at https://doi.org/ 

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10.1056/FNEJMra0904124. 

27. WHO, ‘‘Burns.’’ Available at https://

www.who.int/mediacentre/factsheets/ 

fs365/en/ (last accessed on July 29, 

2022). 

*28. FDA, ‘‘Evaluating the Safety of 

Antimicrobial New Animal Drugs With 

Regard to Their Microbiological Effects 

on Bacteria of Human Health Concern: 

Guidance for Industry,’’ October 23, 

2003. Available at https://www.fda.gov/ 

downloads/AnimalVeterinary/Guidance

ComplianceEnforcement/Guidancefor

Industry/UCM052519.pdf. 

29. Government of Canada, ‘‘Categorization 

of Antimicrobial Drugs Based on 

Importance in Human Medicine,’’ 2009. 

Available at https://www.canada.ca/en/ 

health-canada/services/drugs-healthproducts/veterinary-drugs/antimicrobialresistance/categorization-antimicrobialdrugs-based-importance-humanmedicine.html. 

30. McDonnell G., and A. Russell, 

‘‘Antiseptic and Disinfectants: Activity, 

Action, and Resistance,’’ Clinical 

Microbiology Reviews, 12(1), 147–179, 

1999. Available at https://doi.org/ 

10.11282Fcmr.12.1.147. 

31. Linehanm J., O. Harrison, S. Han, et al., 

‘‘Non-Classical Immunity Controls 

Microbiota Impact on Skin Immunity 

and Tissue Repair,’’ Cell, 172(4), 784– 

796.e18, 2018. Available at https://

doi.org/10.1016/j.cell.2017.12.033. 

32. Johnson T., B. Gomez, M. McIntyre, et al., 

‘‘The Cutaneous Microbiome and 

Wounds: New Molecular Targets To 

Promote Wound Healing,’’ International 


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83796 Federal Register / Vol. 88, No. 229 / Thursday, November 30, 2023 / Proposed Rules 

Journal of Molecular Sciences, 19 (9), 

2699, 2018. Available at https://doi.org/ 

10.3390/ijms19092699. 

33. Leonel C., I. Sena, W. Silva, et al., 

‘‘Staphylococcus Epidermidis Role in the 

Skin Microenvironment,’’ Journal of 

Cellular And Molecular Medicine, 23(9), 

5949–5955, 2019. Available at https://

doi.org/10.1111/jcmm.14415. 

34. Pastar I., K. O’Neill, L. Padula, et al., 

‘‘Staphylococcus Epidermidis Boosts 

Innate Immune Response by Activation 

of Gamma Delta T Cells and Induction of 

Perforin-2 in Human Skin,’’ Frontiers in 

Immunology, 11, 550946, 2020. 

Available at https://doi.org/10.3389/ 

fimmu.2020.550946. 

35. Luqman A., M. Muttaqin, S. Yulaipi, et 

al., ‘‘Trace Amines Produced by Skin 

Bacteria Accelerate Wound Healing in 

Mice,’’ Communications Biology, 3, 277, 

2020. Available at https://doi.org/ 

10.1038/s42003-020-1000-7. 

36. Brown M., A. Horswill, ‘‘Staphylococcus 

Epidermidis—Skin Friend or Foe?’’ 

PLOS Pathogens, 16(11):e1009026, 2020. 

Available at https://doi.org/10.1371/ 

journal.ppat.1009026. 

37. Burke T., M. Rupp, P. Fey, 

‘‘Staphylococcus Epidermidis,’’ Trends 

in Microbiology, 763–764, 2023. 

Available at https://doi.org/10.1016/ 

j.tim.2023.01.001. 

*38. FDA, ‘‘Classification of Products as 

Drugs and Devices & Additional Product 

Classification Issues: Guidance for 

Industry and FDA Staff,’’ September 

2017. Available at https://www.fda.gov/ 

media/80384/download. 

*39. FDA, ‘‘General and Plastic Surgery 

Devices; Classification of the 

Nonresorbable Gauze/Sponge for 

External Use, the Hydrophilic Wound 

Dressing, the Occlusive Wound Dressing, 

and the Hydrogel Wound Dressing,’’ 64 

FR 53927, October 5, 1999. Available at 

https://www.gpo.gov/fdsys/pkg/FR-1999- 

10-05/pdf/99-25791.pdf. 

*40. FDA, ‘‘Medical Devices; Plastic Surgery 

Devices; Classification of Wound 

Dressing With Poly (Diallyl Dimethyl 

Ammonium Chloride) Additive,’’ 74 FR 

53165, October 16, 2009. Available at 

https://www.govinfo.gov/content/pkg/ 

FR-2009-10-16/pdf/E9-24963.pdf. 

41. Choi Y., K. Campbell, C. Levek, et al., 

‘‘Antibiotic Ointment Versus a SilverBased Dressing for Children With 

Extremity Burns: A Randomized 

Controlled Study,’’ Journal of Pediatric 

Surgery, 54(7), 1391–1396, 2019. 

Available at https://

pubmed.ncbi.nlm.nih.gov/29983189/. 

42. Benedetto A., J. Staidle, J. Schoenfeld, et 

al., ‘‘Comparing the Use of a Novel 

Antibiotic-Free Film-Forming Topical 

Wound Dressing Versus a Topical Triple 

Antibiotic in Dermatologic Surgical 

Procedures Including Mohs 

Micrographic Surgery,’’ Journal of 

European Academy of Dermatology and 

Venereology, 35(1), 247–255, 2021. 

Available at https://

pubmed.ncbi.nlm.nih.gov/32978842/. 

43. Kim D., W. Namen Ii, J. Moore, et al., 

‘‘Clinical Assessment of a Biofilmdisrupting Agent for the Management of 

Chronic Wounds Compared With 

Standard of Care: A Therapeutic 

Approach,’’ Wounds, 30(5), 120–130, 

2018. Available at https://

pubmed.ncbi.nlm.nih.gov/29521641/. 

44. Connery S., J. Yankowitz, L. Odibo, et al., 

‘‘Effect of Using Silver Nylon Dressings 

To Prevent Superficial Surgical Site 

Infection After Cesarean Delivery: A 

Randomized Clinical Trial,’’ American 

Journal of Obstetrics and Gynecology, 

221(1):57.e1–57.e7, 2019. Available at 

https://pubmed.ncbi.nlm.nih.gov/ 

30849351/. 

45. Ahmad H., K. Kallies, and S. Shapiro, 

‘‘The Effect of Mupirocin Dressings on 

Postoperative Surgical Site Infections in 

Elective Colorectal Surgery: A 

Prospective, Randomized Controlled 

Trial,’’ The American Journal of Surgery, 

217(6), 1083–1088, 2019. Available at 

https://pubmed.ncbi.nlm.nih.gov/ 

30528317/. 

46. Serena T., L. Serena, O. Al-Jalodi, et al., 

‘‘The Efficacy of Sodium Hypochlorite 

Antiseptic: A Double-Blind, Randomised 

Controlled Pilot Study,’’ Journal of 

Wound Care, 31(Sup2), S32-s35, 2022. 

Available at https://pubmed.ncbi.nlm.

nih.gov/35148643/. 

47. Saad A., E. Salazar, L. Allen, et al., 

‘‘Antimicrobial Dressing Versus 

Standard Dressing in Obese Women 

Undergoing Cesarean Delivery: A 

Randomized Controlled Trial,’’ 

American Journal of Perinatology, 39(9), 

951–958, 2022. Available at https://

pubmed.ncbi.nlm.nih.gov/33264808/. 

48. Dissemond J., J. Steinmann, K. Mu ̈nter, et 

al., ‘‘Risk and Clinical Impact of 

Bacterial Resistance/Susceptibility to 

Silver-Based Wound Dressings: A 

Systematic Review,’’ Journal of Wound 

Care, 29(4), 221–234, 2020. Available at 

https://pubmed.ncbi.nlm.nih.gov/ 

32281507/. 

49. Linehanm J., O. Harrison, S. Han, et al., 

‘‘Non-Classical Immunity Controls 

Microbiota Impact on Skin Immunity 

and Tissue Repair,’’ Cell, 172(4), 784– 

796.e18, 2018. Available at https://

pubmed.ncbi.nlm.nih.gov/29358051/. 

50. Johnson T., B. Gomez, M. McIntyre, et al., 

‘‘The Cutaneous Microbiome and 

Wounds: New Molecular Targets To 

Promote Wound Healing,’’ International 

Journal of Molecular Science, 19(9), 

2699, 2018. Available at https://doi.org/ 

10.3390/ijms19092699. 

51. Leonel C., I. Sena, W. Silva, et al., 

‘‘Staphylococcus Epidermidis Role in the 

Skin Microenvironment,’’ Journal of 

Cellular and Molecular Medicine, 23(9), 

5949–5955, 2019. Available at https://

doi.org/10.1111/jcmm.14415. 

52. Pastar I., K. O’Neill, L. Padula, et al., 

‘‘Staphylococcus Epidermidis Boosts 

Innate Immune Response by Activation 

of Gamma Delta T Cells and Induction of 

Perforin-2 in Human Skin,’’ Frontiers in 

Immunology, 11, 550946, 2020. 

Available at https://doi.org/10.3389/ 

fimmu.2020.550946. 

53. Luqman A., M. Muttaqin, S. Yulaipi, et 

al., ‘‘Trace Amines Produced by Skin 

Bacteria Accelerate Wound Healing in 

Mice,’’ Communications Biology, 3, 277, 

2020. Available at https://doi.org/ 

10.1038/s42003-020-1000-7. 

54. Brown M., A. Horswill, ‘‘Staphylococcus 

Epidermidis—Skin Friend or Foe?’’ 

PLOS Pathogens, 16(11):e1009026, 2020. 

Available at https://doi.org/10.1371/ 

journal.ppat.1009026. 

55. Burke T., M. Rupp, P. Fey, 

‘‘Staphylococcus Epidermidis,’’ Trends 

in Microbiology, 2023. Available at 

https://doi.org/10.1016/ 

j.tim.2023.01.001. 

*56. FDA’s full preliminary analysis of 

economic impacts is available in the 

Docket No. FDA–2023–N–3392 for this 

proposed rule and at https://

www.fda.gov/about-fda/economics-staff/ 

regulatory-impact-analyses-ria. 

List of Subjects in 21 CFR Part 878 

Medical devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, we propose that 21 

CFR part 878 be amended as follows: 

PART 878—GENERAL AND PLASTIC 

SURGERY DEVICES 

■ 1. The authority citation for part 878 

continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 360l, 371. 

■ 2. Add § 878.4016 to subpart E to read 

as follows: 

§ 878.4016 Solid wound dressings 

containing antimicrobials and/or other 

chemicals. 

(a) Identification. A solid wound 

dressing containing antimicrobials and/ 

or other chemicals that are in a category 

listed in paragraph (a)(2) of this section 

is used to cover and protect a wound, 

to absorb exudate, and to maintain 

appropriate moisture balance within the 

wound and is intended for use only on 

external cutaneous (skin) wounds. The 

solid wound dressing materials are 

resorbable or nonresorbable, synthetic 

or naturally derived materials 

(including animal-derived materials 

such as collagen or chitosan), which are 

provided sterile in a form able to hold 

structural integrity temporarily or 

permanently. This regulation does not 

include a solid wound dressing that 

contains only animal-derived materials 

without the presence of antimicrobials 

and/or other chemicals. 

(1) Antimicrobials are used for 

protectant purposes only to reduce 

microbial growth within the solid 

wound dressing while in use, or to 

provide an antimicrobial barrier to 

microbial penetration through the solid 

wound dressing; 


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(2) Categories of other chemicals are 

wound protectants, honey, synthetic 

peptides, or botanical extracts. 

(b) Classification. (1) Class III 

(premarket approval) for solid wound 

dressings that are identified in 

paragraph (a) of this section and that 

contain one or more medically 

important antimicrobials acting as 

protectants. 

(i) Date premarket approval 

application is required. A PMA is 

required to be filed with the Food and 

Drug Administration on or before 

[DATE OF THE LAST DAY OF THE 

30TH FULL CALENDAR MONTH 

AFTER EFFECTIVE DATE OF FINAL 

RULE], for any solid wound dressing, as 

identified in paragraph (a) of this 

section, that either contains one or more 

medically important antimicrobials 

acting as protectants and was in 

commercial distribution before May 28, 

1976, or has, on or before [DATE OF 

THE LAST DAY OF THE 30TH FULL 

CALENDAR MONTH AFTER 

EFFECTIVE DATE OF FINAL RULE], 

been found to be substantially 

equivalent to any solid wound dressing, 

as identified in paragraph (a) of this 

section, that contains one or more 

medically important antimicrobials and 

that was in commercial distribution 

before May 28, 1976. Any other solid 

wound dressing, as identified in 

paragraph (a) of this section, that 

contains one or more medically 

important antimicrobials shall have an 

approved PMA in effect before being 

placed in commercial distribution. 

(ii) [Reserved] 

(2) Class II (special controls) for solid 

wound dressings that are identified in 

paragraph (a) of this section and that 

contain one or more antimicrobials 

acting as protectants with a medium or 

low level of antimicrobial resistance 

(AMR) concern and/or other chemicals. 

The special controls are: 

(i) Performance testing and 

descriptive information. Performance 

testing and descriptive information 

must demonstrate the functionality of 

the solid wound dressing to achieve the 

specified use, including: 

(A) The physical and chemical 

characteristics of the solid wound 

dressing must be established. The 

following must be provided: 

(1) Identity, quantification, and 

purpose of each component in the 

finished product; 

(2) Specifications and characterization 

of each component in the finished 

product; 

(3) Demonstration that each 

component has a purpose and is present 

in appropriate amounts to perform as 

intended under anticipated conditions 

of use, including evaluation of expected 

worst-case conditions; and 

(4) Final release specifications for the 

manufactured solid wound dressing. 

(B) The solid wound dressing must be 

demonstrated to be sterile and the 

sterilization process must be validated. 

(C) The solid wound dressing must be 

demonstrated to be biocompatible. 

(D) Bench performance testing data 

must demonstrate that the solid wound 

dressing performs as intended under 

anticipated conditions of use, including 

evaluation of expected worst-case 

conditions. 

(E) Performance data must support the 

shelf life of the solid wound dressing by 

demonstrating package integrity and 

product functionality over the identified 

shelf life. 

(ii) Antimicrobial characterization 

and performance testing. For solid 

wound dressings containing 

antimicrobials with a medium or low 

level of AMR concern, antimicrobial 

characterization and performance 

testing must address the following: 

(A) Performance data must 

demonstrate that the antimicrobial has a 

purpose and is present in appropriate 

amounts to perform as intended under 

anticipated conditions of use and 

storage conditions, including evaluation 

of worst-case conditions. If the 

antimicrobial is present as a microbial 

barrier to cover and protect a wound, 

microbial barrier testing must be 

conducted to demonstrate elimination 

of passage of microorganisms through 

the solid wound dressing. If the 

antimicrobial is present to inhibit 

microbial growth within the solid 

wound dressing being used to cover and 

protect a wound, antimicrobial 

effectiveness testing must be conducted 

to demonstrate inhibition of microbial 

growth within the solid wound dressing 

during use. This testing must include: 

(1) Establishment of the Minimum 

Effective Concentration (MEC) of the 

antimicrobial in the context of the final 

solid wound dressing under worst-case 

conditions. 

(2) Identification of the period of 

effectiveness (i.e., maximum product 

use life) based on concentration of 

antimicrobial, leachability data, and 

performance under worst-case 

simulated use conditions. 

(3) For the tests conducted, evaluation 

with clinically relevant microbial 

species, including available strains of 

challenge organisms containing specific 

antimicrobial resistance mechanisms as 

part of worst-case scenario performance 

testing. 

(B) Evaluation and identification of 

any probable risks for probable 

contributions to the development and 

spread of antimicrobial resistance must 

be provided, and must include: 

(1) Identification of the antimicrobial, 

proposed mechanism(s) of action, and 

expected spectrum of activity; and 

(2) An AMR assessment for each 

antimicrobial component, including the 

following characterization elements 

based on literature review: 

(i) Known resistance mechanisms; 

(ii) Transmissibility of resistance 

mechanisms; 

(iii) List of resistant microbial species; 

and 

(iv) Potential for coselection (e.g., via 

coresistance or cross-resistance) for 

medically important antimicrobial 

resistance mechanisms. 

(iii) If the solid wound dressing 

contains animal-derived material(s), 

data must include: 

(A) A risk management assessment for 

the inclusion of animal-derived 

material(s) which considers any 

probable risk associated with the 

presence of the animal tissue in the final 

finished solid wound dressing 

(including pathogen and parasite 

infection and immunological reaction). 

The risk management assessment must 

describe how these risks are controlled 

and mitigated by: 

(1) Documentation of the processing 

methods, including methods of animal 

husbandry and tissue selection as well 

as methods for tissue handling, storage, 

transport, and quarantine, that mitigate 

the risk of parasites and pathogens. 

(2) Performance data which 

demonstrates the ability of the 

manufacturing and sterilization 

procedures to ensure the adequate 

removal (i.e., clearance or inactivation) 

of parasites and pathogens (including 

bacteria, mycoplasma, fungi, virus, and 

transmissible spongiform 

encephalopathy agents) from the final 

finished solid wound dressing. 

(B) If the device contains materials 

derived from a new animal species or 

from manufacturing processes which 

cause structural changes (i.e., 

denaturation, modification) to the 

animal protein, performance data (e.g., 

patch and prick testing, human repeat 

insult patch testing) must demonstrate 

that the device is not immunogenic. 

(iv) If the solid wound dressing 

contains a botanical extract, additional 

supporting data must include: 

(A) A risk management assessment for 

including the botanical extract in the 

solid wound dressing which considers 

any probable risk associated with the 

presence of the botanical extract in the 

final finished solid wound dressing. 

(B) The risk management assessment 

must describe how these risks are 


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83798 Federal Register / Vol. 88, No. 229 / Thursday, November 30, 2023 / Proposed Rules 

controlled and mitigated by providing 

the following: 

(1) The chemical composition of the 

botanical extract, including the identity 

and quantification of the chemical 

constituents and impurities (e.g., 

elemental impurities, residual solvents 

and pesticides, microbial contaminants, 

adventitious toxins, and degradation 

products) and the lot-to-lot consistency 

of the botanical extract within the final 

finished solid wound dressing. 

(2) Documentation of the botanical 

extract function and activities after 

topical application. Such information 

must describe the purpose of the 

botanical extract in the solid wound 

dressing and how it is present in 

appropriate amounts to perform as 

intended under anticipated conditions 

of use, including expected worst-case 

conditions. 

(3) Identification of any probable risk 

to health from use of the botanical 

extract and how these risks were 

evaluated and are mitigated via the 

botanical concentration in the final 

product, duration of body contact, 

manufacturing and process controls, 

performance data, and labeling for the 

solid wound dressing. 

(v) The labeling must include: 

(A) A description of the intended user 

population; 

(B) Specific instructions regarding the 

proper placement, sizing, duration of 

use for the solid wound dressing, 

frequency of use, and removal of the 

solid wound dressing, if applicable; 

(C) A list of each ingredient or 

component within the solid wound 

dressing, including the functional role 

of that ingredient within the solid 

wound dressing; 

(D) A warning statement regarding 

any incompatibilities with other 

therapies; 

(E) A warning statement regarding the 

potential for the development of 

infection, including signs of an infection 

and a description of the steps to take in 

case of infection; 

(F) If the solid wound dressing is 

nonresorbable, a warning statement for 

the potential retention of material in the 

wound or the surrounding area; 

(G) A contraindication for any known 

sensitivity to components within the 

product; 

(H) A shelf life (i.e., maximum period 

the unopened solid wound dressing is 

stable while stored on the shelf under a 

specified range of environmental 

conditions); 

(I) A maximum use life per 

application of solid wound dressing 

(i.e., period the solid wound dressing is 

recommended for use prior to removal); 

(J) A statement regarding when to 

discontinue use of the solid wound 

dressing after multiple reapplications 

based on biocompatibility and 

performance testing; and 

(K) For solid wound dressings 

indicated for over-the-counter use, a 

statement specifying conditions, uses, or 

purposes for which the product may be 

safely administered by a lay user 

without the supervision of a licensed 

practitioner. 

(vi) If the solid wound dressing 

contains an antimicrobial, the labeling 

must also include: 

(A) Statement of the role of the 

antimicrobial in the product. 

(B) A warning statement regarding the 

potential for selection of antibiotic 

resistant organisms if the wound 

dressing contains an antimicrobial with 

a medium level of AMR concern. 

(C) Specific instructions regarding 

how and when to properly dispose of 

the product. 

(D) A statement of general 

effectiveness, such as ‘‘antimicrobial,’’ 

‘‘antibacterial,’’ or ‘‘microbial barrier,’’ 

without listing specific test organisms or 

log reduction values. 

(E) A statement explaining that the 

effectiveness of the antimicrobial in 

affecting wound bioburden has not been 

evaluated or established. 

(F) A warning statement regarding the 

potential for the antimicrobial to leach 

from the dressing and negatively impact 

the skin microbiota in the periwound 

area which may result in impaired 

wound healing. 

(vii) Any statements in the labeling 

must be clear such that they may be 

understood by the end user, supported 

by appropriate evidence, and consistent 

with the intended use of covering and 

protecting a wound, absorbing exudate, 

and maintaining appropriate moisture 

balance within the wound. 

■ 3. Add § 878.4017 to subpart E to read 

as follows: 

§ 878.4017 Wound dressings formulated 

as a gel, cream, or ointment containing 

antimicrobials and/or other chemicals. 

(a) Identification. A wound dressing 

formulated as a gel, cream, or ointment 

containing antimicrobials and/or other 

chemicals that are in a category listed in 

paragraph (a)(2) of this section is used 

to maintain appropriate moisture 

balance within the wound and is 

intended for use only on external 

cutaneous (skin) wounds. The wound 

dressing materials are synthetic or 

naturally derived materials (including 

animal-derived materials such as 

collagen or chitosan). Wound dressings 

formulated as a gel, cream, or ointment 

containing antimicrobials and/or other 

chemicals are amorphous and can have 

high water content with thickening 

agents or consist of an oil-water 

emulsion. This regulation does not 

include a wound dressing formulated as 

a gel, cream, or ointment that contains 

only animal-derived materials without 

the presence of antimicrobials and/or 

other chemicals. 

(1) Antimicrobials are used for 

preservative purposes only to maintain 

shelf life for a nonsterile wound 

dressing or a multiple-use wound 

dressing for single patient use only; 

(2) Categories of other chemicals are 

wound protectants, honey, synthetic 

peptides, or botanical extracts. 

(b) Classification. (1) Class III 

(premarket approval) for wound 

dressings formulated as a gel, cream, or 

ointment that are identified in 

paragraph (a) of this section and that 

contain one or more medically 

important antimicrobials acting as 

preservatives. 

(i) Date premarket approval 

application is required. A PMA is 

required to be filed with the Food and 

Drug Administration on or before 

[DATE OF THE LAST DAY OF THE 

30TH FULL CALENDAR MONTH 

AFTER EFFECTIVE DATE OF FINAL 

RULE], for any wound dressing 

formulated as a gel, cream, or ointment, 

as identified in paragraph (a) of this 

section, that either contains one or more 

medically important antimicrobials 

acting as preservatives and was in 

commercial distribution before May 28, 

1976, or has, on or before [DATE OF 

THE LAST DAY OF THE 30TH FULL 

CALENDAR MONTH AFTER 

EFFECTIVE DATE OF FINAL RULE], 

been found to be substantially 

equivalent to any wound dressing 

formulated as a gel, cream, or ointment, 

as identified in paragraph (a) of this 

section, that contains one or more 

medically important antimicrobials and 

that was in commercial distribution 

before May 28, 1976. Any other wound 

dressing formulated as a gel, cream, or 

ointment, as identified in paragraph (a) 

of this section, that contains one or 

more medically important 

antimicrobials shall have an approved 

PMA in effect before being placed in 

commercial distribution. 

(ii) [Reserved] 

(2) Class II (special controls) for 

wound dressings formulated as a gel, 

cream, or ointment that are identified in 

paragraph (a) of this section and that 

contain one or more antimicrobials 

acting as preservatives with a medium 

or low level of AMR concern and/or 

other chemicals. The special controls 

are: 


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Federal Register / Vol. 88, No. 229 / Thursday, November 30, 2023 / Proposed Rules 83799 

(i) Performance testing and 

descriptive information. Performance 

testing and descriptive information 

must demonstrate the functionality of 

the wound dressing formulated as a gel, 

cream, or ointment to achieve the 

specified use, including: 

(A) The physical and chemical 

characteristics of the wound dressing 

formulated as a gel, cream, or ointment 

must be established. The following must 

be provided: 

(1) Identity, quantification, and 

purpose of each component in the 

finished product; 

(2) Specifications and characterization 

of each component in the finished 

product; 

(3) Demonstration that each 

component has a purpose and is present 

in appropriate amounts to perform as 

intended under anticipated conditions 

of use, including evaluation of expected 

worst-case conditions; and 

(4) Final release specifications for the 

manufactured wound dressing 

formulated as a gel, cream, or ointment. 

(B) If labeled as sterile, the wound 

dressing formulated as a gel, cream, or 

ointment must be demonstrated to be 

sterile and the sterilization process must 

be validated. If labeled as nonsterile, 

performance data must demonstrate that 

the product may not be sterilized by 

established sterilization methods and 

each manufactured lot of product has an 

acceptable bioburden level that is 

maintained throughout the stated shelf 

life. 

(C) The wound dressing formulated as 

a gel, cream, or ointment must be 

demonstrated to be biocompatible. 

(D) Bench performance testing data 

must demonstrate that the wound 

dressing formulated as a gel, cream, or 

ointment performs as intended under 

anticipated conditions of use, including 

evaluation of expected worst-case 

conditions. 

(E) Performance data must support the 

shelf life of the wound dressing 

formulated as a gel, cream, or ointment 

by demonstrating package integrity and 

product functionality over the identified 

shelf life. If the product is intended for 

multiple uses after opening, continued 

low bioburden, product stability, and 

functionality over the identified use life 

must be demonstrated. 

(ii) Antimicrobial characterization 

and preservative effectiveness testing. 

For wound dressings formulated as a 

gel, cream, or ointment containing 

antimicrobials with a medium or low 

level of AMR concern, antimicrobial 

characterization and preservative 

effectiveness testing must address the 

following: 

(A) Performance data must 

demonstrate that the antimicrobial has a 

purpose and is present in appropriate 

amounts to perform as intended under 

anticipated conditions of use and 

storage conditions, including evaluation 

of worst-case conditions. This testing 

must include: 

(1) Establishment of the MEC of the 

antimicrobial in the context of the final 

wound dressing formulated as a gel, 

cream, or ointment. 

(2) Identification of the period of 

preservative effectiveness for multipleuse products (i.e., after the product has 

been opened) based on concentration of 

antimicrobial and preservative 

effectiveness testing under worst-case 

simulated use conditions. 

(3) Preservative effectiveness testing 

must be conducted on at least three 

different manufactured lots of the final, 

finished device that has been real-time 

aged for the stated shelf life. If the 

dressing is a multiple-use product, the 

test articles should also be conditioned 

based on worst-case simulated use for 

maximum use life. 

(4) For nonsterile products, 

information should be provided 

regarding the characterization of 

bioburden within the product. 

(B) Evaluation and identification of 

any probable risks for probable 

contributions to the development and 

spread of antimicrobial resistance must 

be provided, and must include: 

(1) Identification of the antimicrobial, 

proposed mechanism(s) of action, and 

expected spectrum of activity; and 

(2) An AMR assessment for each 

antimicrobial component, including the 

following characterization elements 

based on literature review: 

(i) Known resistance mechanisms; 

(ii) Transmissibility of resistance 

mechanisms; 

(iii) List of resistant microbial species; 

and 

(iv) Potential for coselection (e.g., via 

coresistance or cross-resistance) for 

medically important antimicrobial 

resistance mechanisms. 

(iii) If the wound dressing formulated 

as a gel, cream, or ointment contains 

animal-derived material(s), data must 

include: 

(A) A risk management assessment for 

the inclusion of animal-derived 

material(s) which considers any 

probable risk associated with the 

presence of the animal tissue in the final 

finished wound dressing formulated as 

a gel, cream, or ointment (including 

pathogen and parasite infection and 

immunological reaction). The risk 

management assessment must describe 

how these risks are controlled and 

mitigated by: 

(1) Documentation of the processing 

methods, including animal husbandry 

and tissue selection as well as methods 

for tissue storage, transport, and 

quarantine, that mitigate the risk of 

parasites and pathogens. 

(2) Performance data which 

demonstrates the ability of the 

manufacturing and sterilization 

procedures to ensure the adequate 

removal (i.e., clearance or inactivation) 

of parasites and pathogens (including 

bacteria, mycoplasma, fungi, virus, and 

transmissible spongiform 

encephalopathy agents) from the final 

finished wound dressing formulated as 

a gel, cream, or ointment. 

(B) If the device contains materials 

derived from a new animal species or 

from manufacturing processes which 

cause structural changes (i.e., 

denaturation, modification) to the 

animal protein, performance data (e.g., 

patch and prick testing, human repeat 

insult patch testing) must demonstrate 

that the device is not immunogenic. 

(iv) If the wound dressing formulated 

as a gel, cream, or ointment contains a 

botanical extract, additional supporting 

data must include: 

(A) A risk management assessment for 

including the botanical extract in the 

wound dressing formulated as a gel, 

cream, or ointment which considers any 

probable risk associated with the 

presence of the botanical extract in the 

final finished wound dressing 

formulated as a gel, cream, or ointment. 

(B) The risk management assessment 

must describe how these risks are 

controlled and mitigated by providing 

the following: 

(1) The chemical composition of the 

botanical extract, including the identity 

and quantification of the chemical 

constituents and impurities (e.g., 

elemental impurities, residual solvents 

and pesticides, microbial contaminants, 

adventitious toxins, and degradation 

products), and the lot-to-lot consistency 

of the botanical extract within the final 

finished wound dressing formulated as 

a gel, cream, or ointment. 

(2) Documentation of the botanical 

extract function and activities after 

topical application. Such information 

must describe the purpose of the 

botanical extract in the wound dressing 

formulated as a gel, cream, or ointment 

and how it is present in appropriate 

amounts to perform as intended under 

anticipated conditions of use, including 

expected worst-case conditions. 

(3) Identification of any probable risk 

to health from use of the botanical 

extract and how these risks were 

evaluated and are mitigated via the 

botanical concentration in the final 

product, duration of body contact, 


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83800 Federal Register / Vol. 88, No. 229 / Thursday, November 30, 2023 / Proposed Rules 

manufacturing and process controls, 

performance data, and labeling for the 

wound dressing formulated as a gel, 

cream, or ointment. 

(v) The labeling must include: 

(A) A description of the intended user 

population; 

(B) Specific instructions regarding the 

proper application of the product, 

duration of use for the wound dressing, 

frequency of use, and instructions 

regarding the removal of the product 

residuals prior to reapplication, if 

applicable; 

(C) A list of each ingredient or 

component within the wound dressing, 

including the functional role of that 

ingredient within the wound dressing; 

(D) A warning statement regarding 

any incompatibilities with other 

therapies; 

(E) A warning statement regarding the 

potential for the development of 

infection, including signs of an infection 

and a description of the steps to take in 

case of infection; 

(F) A contraindication for any known 

sensitivity to components within the 

product; 

(G) A shelf life (i.e., maximum period 

the unopened wound dressing 

formulated as a gel, cream, or ointment 

is stable while stored on the shelf under 

a specified range of environmental 

conditions); 

(H) The maximum period of use 

(including reapplications) based on 

biocompatibility and performance 

testing; and 

(I) For wound dressings formulated as 

a gel, cream, or ointment indicated for 

over-the-counter use, a statement 

specifying conditions, uses, or purposes 

for which the product may be safely 

administered by a lay user without the 

supervision of a licensed practitioner. 

(vi) If the wound dressing formulated 

as a gel, cream, or ointment contains an 

antimicrobial, the labeling must also 

include: 

(A) Statement of the role of the 

antimicrobial in the product. 

(B) A warning statement regarding the 

potential for selection of antibiotic 

resistant organisms if the wound 

dressing contains an antimicrobial with 

a medium level of AMR concern. 

(C) Specific instructions regarding 

how and when to properly dispose of 

the product. 

(D) A statement of general 

effectiveness, such as ‘‘antimicrobial,’’ 

‘‘antibacterial,’’ or ‘‘microbial barrier,’’ 

without listing specific test organisms or 

log reduction values. 

(E) A statement explaining that the 

effectiveness of the antimicrobial in 

affecting wound bioburden has not been 

evaluated or established. 

(F) A warning statement regarding the 

potential for the antimicrobial to leach 

from the dressing and negatively impact 

the skin microbiota in the periwound 

area which may result in impaired 

wound healing. 

(vii) Any statements in the labeling 

must be clear such that they may be 

understood by the end user, supported 

by appropriate evidence, and consistent 

with the intended use of maintaining 

appropriate moisture balance within the 

wound. 

■ 4. Add § 878.4019 to subpart E to read 

as follows: 

§ 878.4019 Liquid wound washes. 

(a) Identification. A liquid wound 

wash containing antimicrobials and/or 

other chemicals that are in a category 

listed in paragraph (a)(2) of this section 

is a water-based solution used to 

mechanically irrigate and physically 

remove debris from external wounds 

and intended for use on external 

cutaneous (skin) wounds. It is also used 

to moisten solid wound dressings to 

maintain appropriate moisture balance 

within the dressing. This regulation 

does not include liquid wound washes 

that contain only animal-derived 

materials without the presence of 

antimicrobials and/or other chemicals. 

(1) Antimicrobials are used for 

preservative purposes only to maintain 

shelf life for a nonsterile liquid wound 

wash or a multiple-use liquid wound 

wash for single patient use only; 

(2) Categories of other chemicals are 

wound protectants, honey, synthetic 

peptides, or botanical extracts. 

(b) Classification. (1) Class III 

(premarket approval) for liquid wound 

washes that are identified in paragraph 

(a) of this section and that contain one 

or more medically important 

antimicrobials acting as preservatives. 

(i) Date premarket approval 

application is required. A PMA is 

required to be filed with the Food and 

Drug Administration on or before 

[DATE OF THE LAST DAY OF THE 

30TH FULL CALENDAR MONTH 

AFTER EFFECTIVE DATE OF FINAL 

RULE], for any liquid wound wash, as 

identified in paragraph (a) of this 

section, that either contains one or more 

medically important antimicrobials and 

was in commercial distribution before 

May 28, 1976, or has, on or before 

[DATE OF THE LAST DAY OF THE 

30TH FULL CALENDAR MONTH 

AFTER EFFECTIVE DATE OF FINAL 

RULE], been found to be substantially 

equivalent to any liquid wound wash, as 

identified in paragraph (a) of this 

section, that contains one or more 

medically important antimicrobials and 

that was in commercial distribution 

before May 28, 1976. Any other liquid 

wound wash, as identified in paragraph 

(a) of this section, that contains one or 

more medically important 

antimicrobials shall have an approved 

PMA in effect before being placed in 

commercial distribution. 

(ii) [Reserved] 

(2) Class II (special controls) for liquid 

wound washes that are identified in 

paragraph (a) of this section and that 

contain one or more antimicrobials 

acting as preservatives with a medium 

or low level of AMR concern and/or 

other chemicals or when containing 

water or 0.9 percent saline only. The 

special controls for this device are: 

(i) Performance testing and 

descriptive information. Performance 

testing and descriptive information 

must demonstrate the functionality of 

the liquid wound wash to achieve the 

specified use, including: 

(A) The physical and chemical 

characteristics of the liquid wound 

wash must be established. The 

following must be provided: 

(1) Identity, quantification, and 

purpose of each component in the 

finished product; 

(2) Specifications and characterization 

of each component in the finished 

product; 

(3) Demonstration that each 

component has a purpose and is present 

in appropriate amounts to perform as 

intended under anticipated conditions 

of use, including evaluation of expected 

worst-case conditions; and 

(4) Final release specifications for the 

manufactured liquid wound wash. 

(B) If labeled as sterile, the liquid 

wound wash must be demonstrated to 

be sterile and the sterilization process 

must be validated. If labeled as 

nonsterile, performance data must 

demonstrate that the product may not be 

sterilized by established sterilization 

methods and each manufactured lot of 

product has an acceptable bioburden 

level that is maintained throughout the 

stated shelf life. 

(C) The liquid wound wash must be 

demonstrated to be biocompatible. 

(D) Bench performance testing data 

must demonstrate that the liquid wound 

wash performs as intended under 

anticipated conditions of use, including 

evaluation of expected worst-case 

conditions. 

(F) Performance data must support the 

shelf life of the liquid wound wash by 

demonstrating package integrity and 

product functionality over the identified 

shelf life. If the product is intended for 

multiple uses after opening, continued 

low bioburden, product stability, and 

functionality over the identified use life 

must be demonstrated. 


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Federal Register / Vol. 88, No. 229 / Thursday, November 30, 2023 / Proposed Rules 83801 

(ii) Antimicrobial characterization 

and preservative effectiveness testing. 

For liquid wound washes containing 

antimicrobials with a medium or low 

level of AMR concern, antimicrobial 

characterization and preservative 

effectiveness testing must address the 

following: 

(A) Performance data must 

demonstrate that the antimicrobial has a 

purpose and is present in appropriate 

amounts to perform as intended under 

anticipated conditions of use and 

storage conditions, including evaluation 

of worst-case conditions. This testing 

must include: 

(1) Establishment of the MEC of the 

antimicrobial in the context of the final 

liquid wound wash. 

(2) Identification of the period of 

preservative effectiveness for multipleuse products (i.e., after the product has 

been opened) based on concentration of 

antimicrobial and preservative 

effectiveness testing under worst-case 

simulated use conditions. 

(3) Preservative effectiveness testing 

must be conducted on at least three 

different manufactured lots of the final, 

finished device that has been real-time 

aged for the stated shelf life. If the liquid 

wound wash is a multiple-use product, 

the test articles should also be 

conditioned based on worst-case 

simulated use for maximum use life. 

(4) For nonsterile products, 

information should be provided 

regarding the characterization of 

bioburden within the product. 

(B) Evaluation and identification of 

any probable risks for probable 

contributions to the development and 

spread of antimicrobial resistance must 

be provided, and must include: 

(1) Identification of the antimicrobial, 

proposed mechanism(s) of action, and 

expected spectrum of activity; and 

(2) An AMR assessment for each 

antimicrobial component, including the 

following characterization elements 

based on literature review: 

(i) Known resistance mechanisms; 

(ii) Transmissibility of resistance 

mechanisms; 

(iii) List of resistant microbial species; 

and 

(iv) Potential for coselection (e.g., via 

coresistance or cross-resistance) for 

medically important antimicrobial 

resistance mechanisms. 

(iii) If the liquid wound wash 

contains animal-derived material(s), 

data must include: 

(A) A risk management assessment for 

the inclusion of animal-derived 

material(s) which considers any 

probable risk associated with the 

presence of the animal tissue in the final 

finished liquid wound wash (including 

pathogen and parasite infection and 

immunological reaction). The risk 

management assessment must describe 

how these risks are controlled and 

mitigated by: 

(1) Documentation of the processing 

methods, including animal husbandry 

and tissue selection as well as methods 

for tissue storage, transport, and 

quarantine, that mitigate the risk of 

parasites and pathogens. 

(2) Performance data which 

demonstrates the ability of the 

manufacturing and sterilization 

procedures to ensure the adequate 

removal (i.e., clearance or inactivation) 

of parasites and pathogens (including 

bacteria, mycoplasma, fungi, virus, and 

transmissible spongiform 

encephalopathy agents) from the final 

finished liquid wound wash. 

(B) If the device contains materials 

derived from a new animal species or 

from manufacturing processes which 

cause structural changes (i.e., 

denaturation, modification) to the 

animal protein, performance data (e.g., 

patch and prick testing, human repeat 

insult patch testing) must demonstrate 

that the device is not immunogenic. 

(iv) If the liquid wound wash contains 

a botanical extract, additional 

supporting data must include: 

(A) A risk management assessment for 

including the botanical extract in the 

liquid wound wash which considers 

any probable risk associated with the 

presence of the botanical extract in the 

final finished liquid wound wash. 

(B) The risk management assessment 

must describe how these risks are 

controlled and mitigated by providing 

the following: 

(1) The chemical composition of the 

botanical extract, including the identity 

and quantification of the chemical 

constituents and impurities (e.g., 

elemental impurities, residual solvents 

and pesticides, microbial contaminants, 

adventitious toxins, and degradation 

products), and the lot-to-lot consistency 

of the botanical extract within the final 

finished liquid wound wash. 

(2) Documentation of the botanical 

extract function and activities after 

topical application. Such information 

must describe the purpose of the 

botanical extract in the liquid wound 

wash and how it is present in 

appropriate amounts to perform as 

intended under anticipated conditions 

of use, including expected worst-case 

conditions. 

(3) Identification of any probable risk 

to health from use of the botanical 

extract and how these risks were 

evaluated and are mitigated via the 

botanical concentration in the final 

product, duration of body contact, 

manufacturing and process controls, 

performance data, and labeling for the 

liquid wound wash. 

(v) The labeling must include: 

(A) A description of the intended user 

population; 

(B) Specific instructions regarding the 

proper application of the product, 

duration of use for the liquid wound 

wash, and frequency of use if labeled for 

a period of multiple use; 

(C) A list of each ingredient or 

component within the liquid wound 

wash, including the functional role of 

that ingredient within the liquid wound 

wash; 

(D) A warning statement regarding 

any incompatibilities with other 

therapies; 

(E) A warning statement regarding the 

potential for the development of 

infection, including signs of an infection 

and a description of the steps to take in 

case of infection; 

(F) A contraindication for any known 

sensitivity to components within the 

product; 

(G) A shelf life (i.e., maximum period 

the unopened liquid wound wash is 

stable while stored on the shelf under a 

specified range of environmental 

conditions); 

(H) A maximum period of use 

(including reapplications) based on 

biocompatibility and performance 

testing. 

(I) For liquid wound washes indicated 

for over-the-counter use, a statement 

specifying conditions, uses, or purposes 

for which the product may be safely 

administered by a lay user without the 

supervision of a licensed practitioner. 

(vi) If the liquid wound wash contains 

an antimicrobial, the labeling must also 

include: 

(A) Statement of the role of the 

antimicrobial in the product as a 

preservative. 

(B) A warning statement regarding the 

potential for selection of antibiotic 

resistant organisms if the liquid wound 

wash contains an antimicrobial with a 

medium level of AMR concern. 

(C) Specific instructions regarding 

how and when to properly dispose of 

the product. 

(D) A statement of general 

effectiveness, such as ‘‘antimicrobial,’’ 

‘‘antibacterial,’’ or ‘‘microbial barrier,’’ 

without listing specific test organisms or 

log reduction values. 

(E) A statement explaining that the 

effectiveness of the antimicrobial in 

affecting wound bioburden has not been 

evaluated or established. 

(F) A warning statement regarding the 

potential for the antimicrobial to leach 

from the dressing and negatively impact 

the skin microbiota in the periwound 


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83802 Federal Register / Vol. 88, No. 229 / Thursday, November 30, 2023 / Proposed Rules 

area which may result in impaired 

wound healing. 

(vii) Any statements in the labeling 

must be clear such that they may be 

understood by the end user, supported 

by appropriate evidence, and consistent 

with the intended use of mechanically 

irrigating a wound or maintaining 

appropriate moisture balance within a 

solid wound dressing. 

Dated: November 21, 2023. 

Robert M. Califf, 

Commissioner of Food and Drugs. 

[FR Doc. 2023–26209 Filed 11–29–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 878 

[Docket No. FDA–2023–N–3275] 

Effective Date of Requirement for 

Premarket Approval Applications for 

Certain Solid Wound Dressings; 

Wound Dressings Formulated as a Gel, 

Cream, or Ointment; and Liquid Wound 

Washes Containing Medically 

Important Antimicrobials 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed amendment; proposed 

order. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

proposing to require the filing of a 

premarket approval application (PMA) 

for certain solid wound dressings; 

wound dressings formulated as a gel, 

cream, or ointment; and liquid wound 

washes containing antimicrobials with a 

high level of antimicrobial resistance 

(AMR) concern (i.e., medically 

important antimicrobials) acting as 

either protectants or preservatives, 

which are unclassified, preamendments 

devices. FDA is summarizing its 

proposed findings regarding the degree 

or risk of illness or injury designed to 

be eliminated or reduced by requiring 

the devices to meet the PMA 

requirements of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) and the 

benefits to the public from the use of the 

devices. 

DATES: Either electronic or written 

comments on the proposed order must 

be submitted by February 28, 2024. FDA 

intends that, if a final order based on 

this proposed order is issued, anyone 

who wishes to market solid wound 

dressings, wound dressings formulated 

as a gel, cream, or ointment, and liquid 

wound washes containing medically 

important antimicrobials acting as either 

protectants or preservatives must submit 

a PMA prior to the last day of the 30th 

calendar month beginning after the 

month in which the classification of the 

device in class III became effective. See 

section III for the effective date of any 

final order that may publish based on 

this proposed order. See section VI of 

this document for more information 

about submitting a PMA. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

February 28, 2024. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

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– 

2023–N–3275 for ‘‘Effective Date of 

Requirement for Premarket Approval 

Applications for Certain Solid Wound 

Dressings, Wound Dressings Formulated 

as a Gel, Cream, or Ointment, and 

Liquid Wound Washes Containing 

Medically Important Antimicrobials.’’ 

Received comments, those filed 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. 


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