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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. 78N-2646]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the

nonresorbable gauze/sponge for external use, the hydrophilic wound

dressing, the occlusive wound dressing, and the hydrogel wound dressing

into class I (general controls). FDA is also exempting these devices

from premarket notification procedures. This action is being taken

under the Federal Food, Drug, and Cosmetic Act (the act), as amended by

the Medical Device Amendments of 1976 (the 1976 amendments), the Safe

Medical Devices Act of 1990 (SMDA), and the Food and Drug

Administration Modernization Act of 1997 (FDAMA).

EFFECTIVE DATE: November 4, 1999.

FOR FURTHER INFORMATION CONTACT: Gail G. Gantt, Center for Devices and

Radiological Health (HFZ-480), Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850, 301-594-3090.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of September 19, 1989 (54 FR 38600)

(hereinafter referred to as the September 19, 1989 proposal), FDA

issued a proposed rule to classify the following 11 devices: The

nonabsorbable gauze surgical sponge for external use, the hydrophilic

wound and burn dressing, the interactive wound and burn dressing, the

porcine burn dressing, the intravascular catheter securement device,

the medical adhesive tape, the medical adhesive bandage, the adhesive

wound closure, the occlusive wound and burn dressing, the burn sheet,

and the hydrogel wound and burn dressing. Four of the eleven devices

(the liquid bandage, the intravascular catheter securement device, the

medical adhesive tape and bandage, and the burn sheet) were already

classified as general hospital and personal use devices (45 FR 1739,

October 21, 1980).

In the September 19, 1989 proposal, FDA proposed that: (1) The four

general hospital and personal use devices, identified above, be

recodified in the Code of Federal Regulations (CFR) with the general

and plastic surgery devices; (2) the medical adhesive tape and bandage

be divided into four generic devices; (3) the liquid bandage be divided

into two generic devices; and (4) the porcine burn dressing for short-

term use be classified into class I and the porcine burn dressing for

long-term use be classified into class III as the interactive wound and

burn dressing. The proposals were not finalized. Based on the comments

of the September 19, 1989 proposed rule, the General and Plastic

Surgery Devices Panel's (the panel) recommendations, and current wound

care and product use, FDA is finalizing the classification of the

following four wound care devices: The nonresorbable gauze/sponge for

external use, the hydrophilic wound dressing, the occlusive wound

dressing, and the hydrogel wound dressing.

These final rules do not address wound dressings that contain added

drugs such as antimicrobial agents, added biologics such as growth

factors, or are composed of materials derived from animal sources.

These are preamendments devices that FDA intends to classify in the

future.

II. Comments and FDA's Responses

Interested persons were given until November 20, 1989, to comment

on the September 19, 1989 proposed rule. During the comment period, FDA

received following comments.

1. Two comments requested that an additional classification

category be added for the nonsterile hydrogel wound and burn dressing.

The nonsterile device would be for conditions such as minor cuts,

scrapes, burns, and sunburn. The comment stated that components of this

type of hydrogel wound and burn dressing cannot withstand

sterilization.

FDA agrees that the hydrogel wound and burn dressing may be either

sterile or nonsterile and has revised the final rule accordingly.

2. One comment requested that the health risk information be

printed on the wrappings of the devices.

FDA believes that it is adequate that the health risk information

be provided in the outer labeling of the device.

3. One comment stressed the need for price control because low-

income persons generally have little or no health insurance coverage.

FDA notes that the agency has no control over the price of medical

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devices and whether devices are covered by health insurance.

4. Two comments suggested that the proposed classifications were

too restrictive. One comment stated that an effect of the September 19,

1989 proposed rule is that many products will have no classification

and other classified devices would become unclassified. The other

comment requested that the device descriptions be more generalized to

include other wound dressings that do not specifically meet the

proposed descriptions.

FDA is only classifying the four devices identified above at this

time. While it is true that some wound dressings remain unclassified,

no devices that have already been classified will ``become

unclassified'' as a result of this action. The agency will consider

additional wound dressing classification categories in the future.

5. Three comments suggested that nonwoven materials be included in

the description of nonabsorbable gauze surgical sponge for external

use.

FDA agrees with the comment and has included nonwoven materials in

the nonresorbable gauze/sponge for external use identification.

6. One comment recommended that synthetic materials also be

included in the description of nonabsorbable gauze surgical sponge for

external use.

FDA disagrees with the comment. The agency has included synthetic

materials in the identification of the hydrophilic wound dressing

identification.

III. Recommendations of the Panel

Although the panel discussed wound dressings at the July 17, 1995

meeting, the panel did not make classification recommendations for any

of the wound dressing devices. At the November 17, 1998 meeting, the

panel discussed the classification of four of the wound dressings

proposed for classification in 1989, the nonresorbable gauze/sponge for

external use, the hydrophilic wound dressing, the occlusive wound

dressing, and the hydrogel wound dressing. The panel unanimously

recommended that these four wound dressing devices be classified into

class I (general controls) and that they be exempted from premarket

notification procedures (section 510(k) of the act) (21 U.S.C. 360(k))

(Ref. 1). The panel concluded that the safety and effectiveness of the

four wound dressing devices can be reasonably ensured by the following

general controls: (1) Registration and Listing (21 CFR part 807), (2)

General Provisions of the Quality System Regulation (21 CFR part 820),

(3) General Requirements for Reports (21 CFR 820.180), and Complaint

Files (21 CFR 820.198).

IV. Risks to Health

The panel identified the following risks for two of the wound

dressing devices: (1) The nonresorbable gauze/sponge for external use

may become incorporated into a wound if its use is not monitored; and

(2) the occlusive dressing may cause formation of an abscess if it is

placed on an infected wound. The panel identified no specific risks to

health for the hydrogel wound dressing and the hydrophilic wound

dressing.

V. Summary of the Data Upon Which the Recommendation Is Based

The panel based its recommendations on expert testimony presented

to the panel and on the panel members' personal knowledge of and

clinical experience with the nonresorbable gauze/sponge for external

use, the hydrophilic wound dressing, the occlusive wound dressing, and

the hydrogel wound dressing.

VI. FDA's Conclusion

FDA has concluded that the nonresorbable gauze/sponge for external

use, the hydrophilic wound dressing, the occlusive wound dressing, and

the hydrogel wound dressing do not present unreasonable risks to the

public health and that general controls would provide reasonable

assurance of the safety and effectiveness of the devices.

On November 21, 1997, the President signed the FDAMA into law.

Section 206 of the FDAMA added a new section 510(l) to the act (21

U.S.C. 360(l)), which became effective on February 19, 1998. It states

that a class I device is exempt from the premarket notification

requirements under section 510(k) of the act, unless the device is

intended for a use which is of substantial importance in preventing

impairment of human health or it presents a potential unreasonable risk

of illness or injury (hereinafter referred to as ``reserved

criteria''). FDA has determined that the nonresorbable gauze/sponge for

external use, the hydrophilic wound dressing, the occlusive wound

dressing, and the hydrogel wound dressing do not meet the reserved

criteria and, therefore, they should be exempt from the premarket

notification requirements.

FDA has determined that the four general hospital and personal use

devices (the liquid bandage, the intravascular catheter securement

device, the medical adhesive tape and bandage, and the burn sheet)

should remain codified as general hospital and personal use devices (21

CFR part 880). FDA will finalize classifications of the porcine wound

dressing and the interactive wound and burn dressing in the future.

VII. Reference

The following reference has been placed on display in the Dockets

Management Branch, Food and Drug Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852, and may be seen by interested persons

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

1. General and Plastic Surgery Devices Panel Meeting Transcript,

November 17, 1998, pp. 1-119.

VIII. Environmental Impact

The agency has 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. Analysis of Impacts

FDA has examined the impacts of the final rule under Executive

Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as

amended by subtitle D of the Small Business Regulatory Fairness Act of

1996 (Public Law 104-121)), and the Unfunded Mandates Reform Act of

1995 (Public Law 104-4). Executive Order 12866 directs agencies to

assess all costs and benefits 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). The agency believes that this final rule is consistent

with the regulatory philosophy and principles identified in the

Executive Order. In addition, the final rule is not a significant

regulatory action as defined by the Executive Order and so is not

subject to review under the Executive Order.

The Regulatory Flexibility Act requires agencies to analyze

regulatory options that would minimize any significant impact of a rule

on small entities. As noted previously, FDA may classify devices into

one of three regulatory classes according to the degree of control

needed to provide reasonable assurance of safety and effectiveness. FDA

is classifying these four devices into class I, the lowest level of

control allowed. Under the final rule, they will be exempt from

premarket notification. As unclassified preamendments devices, these

devices are already effectively regulated as class

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I devices. Therefore, the agency certifies that this final rule will

not have a significant economic impact on a substantial number of small

entities. Therefore, under the Regulatory Flexibility Act, no further

analysis is required.

X. Paperwork Reduction Act of 1995

FDA concludes that this final rule contains no collections of

information. Therefore, clearance by the Office of Management and

Budget under the Paperwork Reduction Act of 1995 is not required.

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, 21 CFR part

878 is amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

1. The authority citation for 21 CFR part 878 continues to read as

follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

2. Section 878. 4014 is added to subpart E to read as follows:

Sec. 878.4014 Nonresorbable gauze/sponge for external use.

(a) Identification. A nonresorbable gauze/sponge for external use

is a sterile or nonsterile device intended for medical purposes, such

as to be placed directly on a patient's wound to absorb exudate. It

consists of a strip, piece, or pad made from open woven or nonwoven

mesh cotton cellulose or a simple chemical derivative of cellulose.

This classification does not include a nonresorbable gauze/sponge for

external use that contains added drugs such as antimicrobial agents,

added biologics such as growth factors, or is composed of materials

derived from animal sources.

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in part 807, subpart

E of this chapter subject to the limitations in Sec. 878.9.

3. Section 878.4018 is added to subpart E to read as follows:

Sec. 878.4018 Hydrophilic wound dressing.

(a) Identification. A hydrophilic wound dressing is a sterile or

non-sterile device intended to cover a wound and to absorb exudate. It

consists of nonresorbable materials with hydrophilic properties that

are capable of absorbing exudate (e.g., cotton, cotton derivatives,

alginates, dextran, and rayon). This classification does not include a

hydrophilic wound dressing that contains added drugs such as

antimicrobial agents, added biologics such as growth factors, or is

composed of materials derived from animal sources.

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in part 807, subpart

E of this chapter subject to the limitations in Sec. 878.9.

4. Section 878.4020 is added to subpart E to read as follows:

Sec. 878.4020 Occlusive wound dressing.

(a) Identification. An occlusive wound dressing is a nonresorbable,

sterile or non-sterile device intended to cover a wound, to provide or

support a moist wound environment, and to allow the exchange of gases

such as oxygen and water vapor through the device. It consists of a

piece of synthetic polymeric material, such as polyurethane, with or

without an adhesive backing. This classification does not include an

occlusive wound dressing that contains added drugs such as

antimicrobial agents, added biologics such as growth factors, or is

composed of materials derived from animal sources.

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in part 807, subpart

E of this chapter subject to the limitations in Sec. 878.9.

5. Section 878.4022 is added to subpart E to read as follows:

Sec. 878.4022 Hydrogel wound dressing and burn dressing.

(a) Identification. A hydrogel wound dressing is a sterile or non-

sterile device intended to cover a wound, to absorb wound exudate, to

control bleeding or fluid loss, and to protect against abrasion,

friction, desiccation, and contamination. It consists of a

nonresorbable matrix made of hydrophilic polymers or other material in

combination with water (at least 50 percent) and capable of absorbing

exudate. This classification does not include a hydrogel wound dressing

that contains added drugs such as antimicrobial agents, added biologics

such as growth factors, or is composed of materials derived from animal

sources.

(b) Classification. Class I (general controls). The device is

exempt from the premarket notification procedures in part 807, subpart

E of this chapter subject to the limitations in Sec. 878.9.

Dated: September 21, 1999.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center for Devices and

Radiological Health.

[FR Doc. 99-25791 Filed 10-4-99; 8:45 am]

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