[Federal Register Volume 64, Number 192 (Tuesday, October 5, 1999)]
[Rules and Regulations]
[Pages 53927-53929]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-25791]


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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

[[Page 53928]]

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]
BILLING CODE 4160-01-F