70112 Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Rules and Regulations 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 878 

[Docket No. FDA–2010–N–0513] 

Medical Devices; General and Plastic 

Surgery Devices; Classification of 

Non-Powered Suction Apparatus 

Device Intended for Negative Pressure 

Wound Therapy 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is classifying the 

non-powered suction apparatus device 

intended for negative pressure wound 

therapy (NPWT) into class II (special 

controls). The special control that will 

apply to the device is the guidance 

document entitled ‘‘Class II Special 

Controls Guidance Document: NonPowered Suction Apparatus Device 

Intended for Negative Pressure Wound 

Therapy.’’ The agency is classifying the 

device into class II (special controls) in 

order to provide a reasonable assurance 

of safety and effectiveness of the device. 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a notice of 

availability for the guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Non-Powered 

Suction Apparatus Device Intended for 

Negative Pressure Wound Therapy.’’ 

DATES: Effective Date: December 17, 

2010. 

FOR FURTHER INFORMATION CONTACT: 

Jiyoung Dang, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 3615, Silver Spring, 

MD 20993, 301–796–5650. 

SUPPLEMENTARY INFORMATION: 

I. What is the background of this 

rulemaking? 

The Federal Food, Drug, and Cosmetic 

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

as amended by the Medical Device 

Amendments of 1976 (the 1976 

amendments) (Public Law 94–295), the 

Safe Medical Devices Act of 1990 (the 

SMDA) (Public Law 101–629), and the 

Food and Drug Administration 

Modernization Act (the FDAMA) 

(Public Law 107–250) 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 categories 

(classes) of devices, depending on the 

regulatory controls needed to provide 

reasonable assurance of their safety and 

effectiveness. The three categories of 

devices are class I (general controls), 

class II (special controls), and class III 

(premarket approval). 

FDA refers to devices that were not in 

commercial distribution prior to May 

28, 1976 (the date of enactment of the 

1976 amendments), as postamendments 

devices. Postamendments devices are 

classified automatically by statute 

(section 513(f) of the FD&C Act) into 

class III without any FDA rulemaking 

process. These devices remain in class 

III and require premarket approval, 

unless: (1) FDA reclassifies the device 

into class I or II; (2) FDA issues an order 

classifying the device into class I or 

class II in accordance with section 

513(f)(2); or FDA issues an order finding 

the device to be substantially 

equivalent, under section 513(i) of the 

FD&C Act), to a predicate device that 

does not require premarket approval. 

The agency determines whether new 

devices are substantially equivalent to 

predicate devices by means of 

premarket notification procedures in 

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

U.S.C. 360(k)) and part 807 of the 

regulations (21 CFR part 807). 

Section 513(f)(2) of the FD&C Act 

provides that any person who submits a 

premarket notification under section 

510(k) of the FD&C Act for a device that 

has not previously been classified may, 

within 30 days after receiving an order 

classifying the device into class III 

under section 513(f)(1) of the FD&C Act, 

request that FDA classify the device 

under the criteria set forth in section 

513(a)(1) of the FD&C Act. FDA will, 

within 60 days of receiving this request, 

classify the device by written order. 

This classification shall be the initial 

classification of the device. Within 30 

days after the issuance of an order 

classifying the device, FDA must 

publish a notice in the Federal Register 

announcing this classification. 

In accordance with section 513(f)(1) of 

the FD&C Act, FDA issued an order on 

October 28, 2008, classifying the SNaP 

Wound Care Device into class III, 

because it was not substantially 

equivalent to a device that was 

introduced or delivered for introduction 

into interstate commerce for commercial 

distribution before May 28, 1976, or a 

device which was subsequently 

reclassified into class I or class II. On 

November 3, 2008, Spiracur, Inc., 

submitted a petition requesting 

classification of the SNaP Wound Care 

Device under section 513(f)(2) of the 

FD&C Act. The manufacturer 

recommended that the device be 

classified into class II (Ref. 1). 

In accordance with section 513(f)(2) of 

the FD&C Act, FDA reviewed the 

petition in order to classify the device 

under the criteria for classification set 

forth in 513(a)(1) of the FD&C Act. FDA 

classifies devices into class II if general 

controls by themselves are insufficient 

to provide reasonable assurance of 

safety and effectiveness, but there is 

sufficient information to establish 

special controls to provide reasonable 

assurance of the safety and effectiveness 

of the device for its intended use. After 

review of the information submitted in 

the petition, FDA determined that the 

device can be classified into class II 

with the establishment of special 

controls. FDA believes these special 

controls will provide reasonable 

assurance of the safety and effectiveness 

of the device. 

The device is assigned the generic 

name SNaP Wound Care Device, and it 

is identified as non-powered suction 

apparatus device intended for negative 

pressure wound therapy. 

FDA has identified the following risks 

to health associated specifically with 

this type of device and the 

recommended measures to mitigate 

these risks. 

• Adverse tissue reaction 

• Material degradation 

• Improper function of suction 

apparatus (e.g., reflux of waste exudate 

to wound, incorrect delivery of negative 

pressure) 

• Non-compatibility with other 

therapeutics and diagnostics (e.g., MRI, 

hyperbaric chamber, defibrillation) 

• Uncontrolled bleeding 

• Transmission of infectious agents 

• Unsafe use of device (e.g., improper 

wound selection, improper wound 

management, improper placement of 

dressing) 

TABLE 1—RISKS TO HEALTH AND MITIGATION MEASURES

Identified risk Recommended mitigation measures 

Adverse tissue reaction ............................................................................................................................ Section 6. Biocompatibility. 

Section 7. Sterility. 

Material degradation ................................................................................................................................ Section 8. Stability and Shelf Life. 


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Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Rules and Regulations 70113 

TABLE 1—RISKS TO HEALTH AND MITIGATION MEASURES—Continued 

Identified risk Recommended mitigation measures 

Improper function of suction apparatus (e.g., reflux of waste exudate to wound, incorrect delivery of 

negative pressure).

Section 9. Performance Testing. 

Non-compatibility with other therapeutics and diagnostics (e.g., MRI, hyperbaric chamber, 

defibrillation).

Section 9. Performance Testing. 

Section 11. Labeling. 

Uncontrolled bleeding .............................................................................................................................. Section 11. Labeling. 

Transmission of infectious agents ........................................................................................................... Section 11. Labeling. 

Unsafe use of device (e.g., improper wound selection, improper wound management, improper 

placement of dressing).

Section 11. Labeling. 

FDA believes that the special controls 

guidance document, in addition to 

general controls, address the risks to 

health identified in table 1 of this 

document and provides reasonable 

assurance of the safety and effectiveness 

of the device. Therefore, on August 7, 

2009, FDA issued an order to the 

petitioner classifying the device into 

class II. FDA is codifying this device by 

adding 21 CFR 878.4683. 

Following the effective date of the 

final classification rule, any firm 

submitting a 510(k) premarket 

notification for a non-powered suction 

apparatus device intended for negative 

pressure wound therapy will need to 

address the issues covered in the special 

controls guidance. However, the firm 

need only show that its device meets the 

recommendations of the guidance or in 

some other way provides equivalent 

assurance of safety and effectiveness. 

Section 510(m) of the FD&C Act 

provides that FDA may exempt a class 

II device from the premarket notification 

requirement under section 510(k) of the 

FD&C Act, if FDA determines that 

premarket notification is not necessary 

to provide reasonable assurance of the 

safety and effectiveness of the device. 

For this type of device, FDA has 

determined that premarket notification 

is necessary to provide reasonable 

assurance of the safety and effectiveness 

of the device and, therefore, the type of 

device is not exempt from premarket 

notification requirements. Persons who 

intend to market this type of device 

must submit to FDA a premarket 

notification, prior to marketing the 

device, which contains information 

about the non-powered suction 

apparatus device intended for negative 

presure wound therapy they intend to 

market. 

II. What is the environmental impact of 

this rule? 

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. 

III. What is the economic impact of this 

rule? 

FDA has examined the impacts of the 

final rule under Executive Order 12866 

and the Regulatory Flexibility Act (5 

U.S.C. 601–612), and the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

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 not 

a significant regulatory action as defined 

by the Executive order and so it is not 

subject to review under Executive order. 

The Regulatory Flexibility Act 

requires agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because reclassification of this 

device from class III to class II will 

relieve manufacturers of the device of 

the cost of complying with the 

premarket approval requirements of 

section 515 of the FD&C Act (21 U.S.C. 

360e), and may permit small potential 

competitors to enter the marketplace by 

lowering their costs, the agency certifies 

that the final rule will not have a 

significant economic impact on a 

substantial number of small entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, 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 $135 

million, using the most current (2009) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this final rule to result in any 1-year 

expenditure that would meet or exceed 

this amount. 

IV. Does this final rule have federalism 

implications? 

FDA has analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. Section 4(a) 

of the Executive order requires agencies 

to ‘‘construe * * * a Federal statute to 

preempt State law only where the 

statute contains an express preemption 

provision or there is some other clear 

evidence that the Congress intended 

preemption of State law, or where the 

exercise of State authority conflicts with 

the exercise of Federal authority under 

the Federal statute.’’ Federal law 

includes an express preemption 

provision that preempts certain State 

requirements ‘‘different from or in 

addition to’’ certain Federal 

requirements applicable to devices. 21 

U.S.C. 360k; See Medtronic v. Lohr, 518 

U.S. 470 (1996); Riegel v. Medtronic, 

552 U.S. 312 (2008). The special 

controls established by this final rule 

create ‘‘requirements’’ to address each 

identified risk to health presented by 

these specific medical devices under 21 

U.S.C. 360k, even though product 

sponsors have some flexibility in how 

they meet those requirements. Cf. 

Papike v. Tambrands, Inc., 107 F.3d 

737, 740–42 (9th Cir. 1997). 

V. How does this rule comply with the 

Paperwork Reduction Act of 1995? 

This final rule contains no new 

collections of information. Therefore, 

clearance by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995 is not required. 

Elsewhere in this issue of the Federal 

Register, FDA is issuing a notice 

announcing the guidance for the final 

rule. This guidance, ‘‘Class II Special 

Controls Guidance Document: Nonpowered Suction Apparatus Device 

Intended for Negative Pressure Wound 

Therapy,’’ references previously 

approved collections of information 

found in FDA regulations. 


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70114 Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Rules and Regulations 

VI. What references are on display? 

The following reference has been 

placed on display in the Division of 

Dockets Management (HFA–305), 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. Petition from Spiracur, Inc., 

November 3, 2008. 

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 878.4683 is added to 

subpart E to read as follows: 

§ 878.4683 Non-Powered suction 

apparatus device intended for negative 

pressure wound therapy. 

(a) Identification. A non-powered 

suction apparatus device intended for 

negative pressure wound therapy is a 

device that is indicated for wound 

management via application of negative 

pressure to the wound for removal of 

fluids, including wound exudate, 

irrigation fluids, and infectious 

materials. It is further indicated for 

management of wounds, burns, flaps, 

and grafts. 

(b) Classification. Class II (special 

controls). The special control for this 

device is FDA’s ‘‘Class II Special 

Controls Guidance Document: Nonpowered Suction Apparatus Device 

Intended for Negative Pressure Wound 

Therapy (NPWT).’’ See § 878.1(e) for the 

availability of this guidance document. 

Dated: November 10, 2010. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2010–28873 Filed 11–16–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 54 

[TD 9506] 

RIN 1545–BJ91 

DEPARTMENT OF LABOR 

Employee Benefits Security 

Administration 

29 CFR Part 2590 

RIN 1210–AB42 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of Consumer Information and 

Insurance Oversight 

45 CFR Part 147 

RIN 0950–AA17 

[OCIIO–9991–IFC2] 

Amendment to the Interim Final Rules 

for Group Health Plans and Health 

Insurance Coverage Relating to Status 

as a Grandfathered Health Plan Under 

the Patient Protection and Affordable 

Care Act 

AGENCY: Internal Revenue Service, 

Department of the Treasury; Employee 

Benefits Security Administration, 

Department of Labor; Office of 

Consumer Information and Insurance 

Oversight, Department of Health and 

Human Services. 

ACTION: Amendment to interim final 

rules with request for comments. 

SUMMARY: This document contains an 

amendment to interim final regulations 

implementing the rules for group health 

plans and health insurance coverage in 

the group and individual markets under 

provisions of the Patient Protection and 

Affordable Care Act regarding status as 

a grandfathered health plan; the 

amendment permits certain changes in 

policies, certificates, or contracts of 

insurance without loss of grandfathered 

status. 

DATES: Effective Date. This amendment 

to the interim final regulations is 

effective on November 15, 2010. 

Comment Date. Comments are due on 

or before December 17, 2010. 

ADDRESSES: Written comments may be 

submitted to any of the addresses 

specified below. Any comment that is 

submitted to any Department will be 

shared with the other Departments. 

Please do not submit duplicates. 

All comments will be made available 

to the public. Warning: Do not include 

any personally identifiable information 

(such as name, address, or other contact 

information) or confidential business 

information that you do not want 

publicly disclosed. All comments may 

be posted on the Internet and can be 

retrieved by most Internet search 

engines. Comments may be submitted 

anonymously. 

Department of Labor. Comments to 

the Department of Labor, identified by 

RIN 1210–AB42, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• E-mail: EOHPSCA1251amend.EBSA@dol.gov. 

• Mail or Hand Delivery: Office of 

Health Plan Standards and Compliance 

Assistance, Employee Benefits Security 

Administration, Room N–5653, U.S. 

Department of Labor, 200 Constitution 

Avenue NW., Washington, DC 20210, 

Attention: RIN 1210–AB42. 

Comments received by the 

Department of Labor will be posted 

without change to http:// 

www.regulations.gov and http:// 

www.dol.gov/ebsa, and available for 

public inspection at the Public 

Disclosure Room, N–1513, Employee 

Benefits Security Administration, 200 

Constitution Avenue, NW., Washington, 

DC 20210. 

Department of Health and Human 

Services. In commenting, please refer to 

file code OCIIO–9991–IFC2. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

• Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the instructions under the ‘‘More Search 

Options’’ tab. 

• By regular mail. You may mail 

written comments to the following 

address ONLY: Office of Consumer 

Information and Insurance Oversight, 

Department of Health and Human 

Services, Attention: OCIIO–9991–IFC2, 

Room 445–G, Hubert H. Humphrey 

Building, 200 Independence Avenue, 

SW., Washington, DC 20201. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

• By express or overnight mail. You 

may send written comments to the 

following address only: Office of 

Consumer Information and Insurance 

Oversight, Department of Health and 

Human Services, Attention: OCIIO– 


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