[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
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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]
BILLING CODE 4160-01-F