52294 Federal Register / Vol. 75, No. 164 / Wednesday, August 25, 2010 / Proposed Rules 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Incorporation by reference, 

Safety. 

The Proposed Amendment 

Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA proposes to amend 14 CFR part 

39 as follows: 

PART 39—AIRWORTHINESS 

DIRECTIVES 

1. The authority citation for part 39 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40113, 44701. 

§ 39.13 [Amended] 

2. The FAA amends § 39.13 by adding 

the following new AD: 

Diamond Aircraft Industries GmbH: Docket 

No. FAA–2010–0845; Directorate 

Identifier 2010–CE–044–AD. 

Comments Due Date 

(a) We must receive comments on this 

airworthiness directive (AD) action by 

October 12, 2010. 

Affected ADs 

(b) None. 

Applicability 

(c) This AD applies to Diamond Aircraft 

Industries GmbH Models DA 40 and DA 40F 

airplanes, all serial numbers (S/N), that are 

certificated in any category. 

Subject 

(d) Air Transport Association of America 

(ATA) Code 52: Doors. 

Unsafe Condition 

(e) This AD results from several reports of 

the rear passenger door departing the 

airplane in flight. We are proposing this AD 

to change the emergency open doors 

procedure and retrofit the rear passenger 

door retaining bracket, which if not corrected 

could result in the rear passenger door 

departing the airplane in flight. 

Compliance 

(f) To address this problem, you must do 

the following, unless already done: 

Actions Compliance Procedures 

(1) For all serial numbers: Incorporate Diamond 

Aircraft Temporary Revision TR–MA ̈ M 40– 

428, page 3–37b, dated April 30, 2010, into 

the FAA-approved airplane flight manual.

Within 6 months after the effective date of this 

AD.

Follow Diamond Aircraft Temporary Revision 

TR–MA ̈ M 40–428, Cover Page, dated April 

30, 2010. 

(2) For Model DA 40, S/N 40.006 through 

40.009, 40.011 through 40.081, 40.084, and 

40.201 through 40.749; and Model DA 40F 

S/N 40.FC001 through 40.FC009: Replace 

the rear passenger door retaining bracket 

with an improved design retaining bracket.

Within 6 months after the effective date of this 

AD.

Follow Diamond Aircraft Industries GmbH 

Mandatory Service Bulletin NO. MSB 40– 

070/NO. MSB D4–079/NO. MSB F4–024, 

dated April 30, 2010; and Diamond Aircraft 

Industries GmbH Work Instruction WI–MSB 

40–070/WI–MSB D4–079/WI–MSB F4–024, 

dated April 30, 2010. 

Alternative Methods of Compliance 

(AMOCs) 

(g) The Manager, Small Airplane 

Directorate, FAA, has the authority to 

approve AMOCs for this AD, if requested 

using the procedures found in 14 CFR 39.19. 

Send information to ATTN: Mike Kiesov, 

Aerospace Engineer, FAA, Small Airplane 

Directorate, 901 Locust, Room 301, Kansas 

City, Missouri 64106; telephone: (816) 329– 

4144; fax: (816) 329–4090; e-mail: 

mike.kiesov@faa.gov. Before using any 

approved AMOC on any airplane to which 

the AMOC applies, notify your appropriate 

principal inspector (PI) in the FAA Flight 

Standards District Office (FSDO), or lacking 

a PI, your local FSDO. 

Related Information 

(h) To get copies of the service information 

referenced in this AD, contact Diamond 

Aircraft Industries GmbH, N.A. Otto-Stra+e 5, 

A–2700 Wiener Neustadt, Austria, telephone: 

+43 2622 26700; fax: +43 2622 26780; e-mail: 

office@diamond-air.at; Internet: http:// 

www.diamond-air.at. To view the AD docket, 

go to U.S. Department of Transportation, 

Docket Operations, M–30, West Building 

Ground Floor, Room W12–140, 1200 New 

Jersey Avenue, SE., Washington, DC 20590, 

or on the Internet at http:// 

www.regulations.gov. 

Issued in Kansas City, Missouri, on August 

18, 2010. 

John R. Colomy, 

Acting Manager, Small Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 2010–21068 Filed 8–24–10; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 870, 884 and 892 

[Docket No. FDA–2010–N–0412] 

RIN 0910–AG51 

Effective Date of Requirement for 

Premarket Approval for Four Class III 

Preamendments Devices 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is proposing to 

require the filing of a premarket 

approval application (PMA) or a notice 

of completion of a product development 

protocol (PDP) for the following four 

class III preamendments devices: 

Ventricular bypass (assist) device; 

pacemaker repair or replacement 

material; female condom; and 

transilluminator for breast evaluation. 

The agency is also summarizing its 

proposed findings regarding the degree 

of risk of illness or injury designed to 

be eliminated or reduced by requiring 

the devices to meet the statute’s 

approval requirements and the benefits 

to the public from the use of the 

devices. In addition, FDA is announcing 

the opportunity for interested persons to 

request that the agency change the 

classification of any of the 

aforementioned devices based on new 

information. This action implements 

certain statutory requirements. 

DATES: Submit written or electronic 

comments by November 23, 2010. 

Submit requests for a change in 

classification by September 9, 2010. 

FDA intends that, if a final rule based 

on this proposed rule is issued, anyone 

who wishes to continue to market the 

device will need to submit a PMA 

within 90 days of the effective date of 

the final rule. Please see section XIII of 

this document for the effective date of 

any final rule that may publish based on 

this proposal. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2010–N– 

0412 and/or RIN number 0910–AG51, 

by any of the following methods: 

Electronic Submissions 


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Federal Register / Vol. 75, No. 164 / Wednesday, August 25, 2010 / Proposed Rules 52295 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier (for 

paper, disk, or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

Instructions: All submissions received 

must include the agency name and 

Docket Number and Regulatory 

Information Number (RIN) for this 

rulemaking. All comments received may 

be posted without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

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 Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Michael Ryan, Food and Drug 

Administration, Center for Devices and 

Radiological Health, 10903 New 

Hampshire Ave., Bldg. 66, rm. 1615, 

Silver Spring, MD 20993, 301–796– 

6283. 

SUPPLEMENTARY INFORMATION: 

I. Background—Regulatory Authorities 

The Federal Food, Drug, and Cosmetic 

Act (the act), 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 of 1997 (FDAMA) 

(Public Law 105–115), the Medical 

Device User Fee and Modernization Act 

of 2002 (Public Law 107–250), the 

Medical Devices Technical Corrections 

Act (Public Law 108–214), and the Food 

and Drug Administration Amendments 

Act of 2007 (Public Law 110–85), 

establish a comprehensive system for 

the regulation of medical devices 

intended for human use. Section 513 of 

the act (21 U.S.C. 360c) established 

three categories (classes) of devices, 

reflecting 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). 

Under section 513 of the act, devices 

that were in commercial distribution 

before the enactment of the 1976 

amendments, May 28, 1976 (generally 

referred to as preamendments devices), 

are classified after FDA has: (1) 

Received a recommendation from a 

device classification panel (an FDA 

advisory committee); (2) published the 

panel’s recommendation for comment, 

along with a proposed regulation 

classifying the device; and (3) published 

a final regulation classifying the device. 

FDA has classified most 

preamendments devices under these 

procedures. 

Devices that were not in commercial 

distribution prior to May 28, 1976 

(generally referred to as 

postamendments devices), are 

automatically classified by section 

513(f) of the act into class III without 

any FDA rulemaking process. Those 

devices remain in class III and require 

premarket approval unless, and until, 

the device is reclassified into class I or 

II or FDA issues an order finding the 

device to be substantially equivalent, in 

accordance with section 513(i) of the 

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 act (21 U.S.C. 360(k)) and 21 CFR 

part 807. 

A preamendments device that has 

been classified into class III may be 

marketed by means of premarket 

notification procedures (510(k) process) 

without submission of a premarket 

approval application (PMA) until FDA 

promulgates a final regulation under 

section 515(b) of the act (21 U.S.C. 

360e(b)) requiring premarket approval. 

Section 515(b)(1) of the act (21 U.S.C. 

360e(b)(1)) establishes the requirement 

that a preamendments device that FDA 

has classified into class III is subject to 

premarket approval. A preamendments 

class III device may be commercially 

distributed without an approved PMA 

or a notice of completion of a PDP until 

90 days after FDA issues a final rule 

requiring premarket approval for the 

device, or 30 months after final 

classification of the device under 

section 513 of the act, whichever is 

later. Also, a preamendments device 

subject to the rulemaking procedure 

under section 515(b) of the act is not 

required to have an approved 

investigational device exemption (IDE) 

(see 21 CFR part 812) contemporaneous 

with its interstate distribution until the 

date identified by FDA in the final rule 

requiring the submission of a PMA for 

the device. At that time, an IDE is 

required only if a PMA has not been 

submitted or a PDP completed. 

Section 515(b)(2)(A) of the act 

provides that a proceeding to issue a 

final rule to require premarket approval 

shall be initiated by publication of a 

notice of proposed rulemaking 

containing: (1) The regulation; (2) 

proposed findings with respect to the 

degree of risk of illness or injury 

designed to be eliminated or reduced by 

requiring the device to have an 

approved PMA or a declared completed 

PDP and the benefit to the public from 

the use of the device; (3) an opportunity 

for the submission of comments on the 

proposed rule and the proposed 

findings; and (4) an opportunity to 

request a change in the classification of 

the device based on new information 

relevant to the classification of the 

device. 

Section 515(b)(2)(B) of the act 

provides that if FDA receives a request 

for a change in the classification of the 

device within 15 days of the publication 

of the notice, FDA shall, within 180 

days of the publication of the notice, 

consult with the appropriate FDA 

advisory committee and publish a 

notice denying the request for change in 

reclassification or announcing its intent 

to initiate a proceeding to reclassify the 

device under section 513(e) of the act. 

Section 515(b)(3) of the act provides that 

FDA shall, after the close of the 

comment period on the proposed rule 

and consideration of any comments 

received, issue a final rule to require 

premarket approval or publish a 

document terminating the proceeding 

together with the reasons for such 

termination. If FDA terminates the 

proceeding, FDA is required to initiate 

reclassification of the device under 

section 513(e) of the act, unless the 

reason for termination is that the device 

is a banned device under section 516 of 

the act (21 U.S.C. 360f). 

If a proposed rule to require 

premarket approval for a 

preamendments device is finalized, 

section 501(f)(2)(B) of the act (21 U.S.C. 

351(f)(2)(B)) requires that a PMA or 

notice of completion of a PDP for any 

such device be filed within 90 days of 

the date of issuance of the final rule or 

30 months after the final classification 

of the device under section 513 of the 

act, whichever is later. If a PMA or 

notice of completion of a PDP is not 

filed by the later of the two dates, 

commercial distribution of the device is 

required to cease since the device would 


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be deemed adulterated under section 

501(f) of the act. 

The device may, however, be 

distributed for investigational use if the 

manufacturer, importer, or other 

sponsor of the device complies with the 

IDE regulations. If a PMA or notice of 

completion of a PDP is not filed by the 

later of the two dates, and the device 

does not comply with IDE regulations, 

the device is deemed to be adulterated 

within the meaning of section 

501(f)(1)(A) of the act, and subject to 

seizure and condemnation under 

section 304 of the act (21 U.S.C. 334) if 

its distribution continues. Shipment of 

devices in interstate commerce will be 

subject to injunction under section 302 

of the act (21 U.S.C. 332), and the 

individuals responsible for such 

shipment will be subject to prosecution 

under section 303 of the act (21 U.S.C. 

333). In the past, FDA has requested that 

manufacturers take action to prevent the 

further use of devices for which no PMA 

or PDP has been filed and may 

determine that such a request is 

appropriate for the class III devices that 

are the subjects of this regulation. 

The act does not permit an extension 

of the 90-day period after issuance of a 

final rule within which an application 

or a notice is required to be filed. The 

House Report on the 1976 amendments 

states that: [t]he thirty month grace 

period afforded after classification of a 

device into class III * * * is sufficient 

time for manufacturers and importers to 

develop the data and conduct the 

investigations necessary to support an 

application for premarket approval (H. 

Rept. 94–853, 94th Cong., 2d sess. 42 

(1976)). 

The SMDA added section 515(i) to the 

act requiring FDA to review the 

classification of preamendments class III 

devices for which no final rule requiring 

the submission of PMAs has been 

issued, and to determine whether or not 

each device should be reclassified into 

class I or class II or remain in class III. 

For devices remaining in class III, the 

SMDA directed FDA to develop a 

schedule for issuing regulations to 

require premarket approval. The SMDA 

does not, however, prevent FDA from 

proceeding immediately to rulemaking 

under section 515(b) of the act on 

specific devices, in the interest of public 

health, independent of the procedures 

of section 515(i). Proceeding directly to 

rulemaking under section 515(b) of the 

act is consistent with Congress’ 

objective in enacting section 515(i), i.e., 

that preamendments class III devices for 

which PMAs have not been previously 

required either be reclassified to class I 

or class II or be subject to the 

requirements of premarket approval. 

Moreover, in this proposal, interested 

persons are being offered the 

opportunity to request reclassification of 

any of the devices. 

II. Dates New Requirements Apply 

In accordance with section 515(b) of 

the act, FDA is proposing to require that 

a PMA or a notice of completion of a 

PDP be filed with the agency for class 

III devices within 90 days after issuance 

of any final rule based on this proposal. 

An applicant whose device was legally 

in commercial distribution before May 

28, 1976, or whose device has been 

found to be substantially equivalent to 

such a device, will be permitted to 

continue marketing such class III 

devices during FDA’s review of the 

PMA or notice of completion of the 

PDP. FDA intends to review any PMA 

for the device within 180 days, and any 

notice of completion of a PDP for the 

device within 90 days of the date of 

filing. FDA cautions that under section 

515(d)(1)(B)(i) of the act, the agency may 

not enter into an agreement to extend 

the review period for a PMA beyond 180 

days unless the agency finds that ‘‘the 

continued availability of the device is 

necessary for the public health.’’ 

FDA intends that under § 812.2(d) (21 

CFR 812.2(d)), the preamble to any final 

rule based on this proposal will state 

that, as of the date on which the filing 

of a PMA or a notice of completion of 

a PDP is required to be filed, the 

exemptions from the requirements of 

the IDE regulations for preamendments 

class III devices in § 812.2(c)(1) and 

(c)(2) will cease to apply to any device 

that is: (1) Not legally on the market on 

or before that date, or (2) legally on the 

market on or before that date but for 

which a PMA or notice of completion of 

a PDP is not filed by that date, or for 

which PMA approval has been denied 

or withdrawn. 

If a PMA or notice of completion of 

a PDP for a class III device is not filed 

with FDA within 90 days after the date 

of issuance of any final rule requiring 

premarket approval for the device, 

commercial distribution of the device 

must cease. The device may be 

distributed for investigational use only 

if the requirements of the IDE 

regulations are met. The requirements 

for significant risk devices include 

submitting an IDE application to FDA 

for its review and approval. An 

approved IDE is required to be in effect 

before an investigation of the device 

may be initiated or continued under 21 

CFR 812.30. FDA, therefore, cautions 

that IDE applications should be 

submitted to FDA at least 30 days before 

the end of the 90-day period after the 

issuance of the final rule to avoid 

interrupting investigations. 

III. Proposed Findings With Respect to 

Risks and Benefits 

As required by section 515(b) of the 

act, FDA is publishing its proposed 

findings regarding: (1) The degree of risk 

of illness or injury designed to be 

eliminated or reduced by requiring that 

these devices have an approved PMA or 

a declared completed PDP, and (2) the 

benefits to the public from the use of the 

devices. 

These findings are based on the 

reports and recommendations of the 

advisory committees (panels) for the 

classification of these devices along 

with information submitted in response 

to the 515(i) order (74 FR 16214, April 

9, 2009) and any additional information 

that FDA has encountered. Additional 

information regarding the risks as well 

as classification associated with these 

device types can be found in the 

following proposed and final rules 

published in the Federal Register on 

these dates: Cardiovascular devices, 21 

CFR part 870 (44 FR 13284, March 9, 

1979; 45 FR 7904, February 5, 1980; and 

52 FR 17736, May 11, 1987); 

classification of female condoms (64 FR 

31164, June 10, 1999; and 65 FR 31454, 

May 18, 2000); and classification of 

transilluminators (diaphanoscopes or 

lightscanners) for breast evaluation (60 

FR 3168, January 13, 1995; and 60 FR 

36639, July 18, 1995). 

IV. Devices Subject to This Proposal 

A. Ventricular bypass (assist) device (21 

CFR 870.3545) 

1. Identification 

A ventricular bypass (assist) device is 

a device that assists the left or right 

ventricle in maintaining circulatory 

blood flow. The device is either totally 

or partially implanted in the body. 

2. Summary of Data 

The Cardiovascular Devices Panel 

recommended that ventricular bypass 

(assist) devices be classified into class 

III because the device is an implant used 

in a life-supporting situation. The panel 

indicated that general controls alone 

would not be sufficient and that there 

was not enough information to establish 

a performance standard. Consequently, 

the panel believed that premarket 

approval is necessary to assure the 

safety and effectiveness of the device. 

FDA continues to agree with the panel’s 

recommendation. 

3. Risks to Health 

a. Thromboembolism—inadequate 

blood compatibility of the materials 


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used in this device and inadequate 

surface finish and cleanliness could 

lead to potentially debilitating or fatal 

thromboembolism. 

b. Excessive hemolysis—poor design 

of the hemodynamic characteristics of 

the device can lead to excess hemolysis. 

c. Inability to support life—inaccurate 

pressure or flow control or improper 

synchronization can impede the ability 

of the device to support life. 

d. Cardiac arrhythmias or electrical 

shock—excessive electrical leakage 

current can disturb the normal 

electrophysiology of the heart, leading 

to the onset of cardiac arrhythmias. 

Electrical leakage can also cause 

electrical shock to the physician during 

placement or use of the device and this 

could lead to iatrogenic complications. 

e. Interference with other organs— 

because of the device’s size and the 

location of its implantation, the device 

may interfere with the function of other 

organs. 

f. Damage to blood vessels—the 

mechanical design of the attachments is 

associated with the possibility of 

damage to blood vessels at the 

attachment points. 

g. Inability to maintain long-term 

support—low fatigue life of the 

materials used or poor quality control in 

construction can lead to premature 

breakdown of the device. 

B. Pacemaker repair or replacement 

material (21 CFR 870.3710) 

1. Identification 

A pacemaker repair or replacement 

material is an adhesive, a sealant, a 

screw, a crimp, or any other material 

used to repair a pacemaker lead or to 

reconnect a pacemaker lead to a 

pacemaker pulse generator. 

2. Summary of Data 

The Cardiovascular Devices 

Classification Panel recommended that 

pacemaker repair or replacement 

material be classified into class III 

because of the potential hazards 

associated with the inherent properties 

of the device, the life-supporting 

function of this implanted device, and 

its personal knowledge of, and 

experience with, the device. FDA agreed 

and continues to agree with the panel’s 

recommendation. The agency notes that 

the device has fallen into disuse and 

that the published data are not adequate 

to demonstrate the safety and 

effectiveness of the device. 

3. Risks to Health 

a. Tissue damage—If the 

biocompatibility of the materials used in 

this device is inadequate, damage to the 

surrounding tissue may result. 

b. Loss of pacing function—Failure to 

properly repair or reconnect a 

pacemaker lead could result in loss of 

pacing function. The need to repair/ 

reconnect the lead may be due to, 

among other causes, an intrusion of 

fluid into the pacemaker connection, an 

improper electrical connection to the 

pacemaker circuitry, or poor electrical 

insulation of the lead body. If the lead 

is not repaired or reconnected, the 

electrical path from the pulse generator 

to the lead may be interrupted, resulting 

in a loss of critical and potentially lifesustaining pacing function. 

C. Female condom (21 CFR 884.5330) 

1. Identification 

A female condom is a sheath-like 

device that lines the vaginal wall and is 

inserted into the vagina prior to the 

initiation of coitus. It is indicated for 

contraceptive and prophylactic 

(preventing the transmission of sexually 

transmitted diseases (STDs)) purposes. 

2. Summary of Data 

The Obstetrics-Gynecology Devices 

Panel recommended that the female 

condom device be classified into Class 

III (premarket approval). The panel gave 

reasons for recommendation, e.g., that 

no published data could be found that 

demonstrate the safety and effectiveness 

of the device. The panel based the 

recommendation on information 

provided by FDA and on the panel 

members’ personal knowledge of and 

experience with contraceptive methods 

of birth control, including barrier-type 

contraceptives. Additionally, the panel 

believed that general controls and 

special controls would not provide 

reasonable assurance of the safety and 

effectiveness of the devices. FDA has 

not received any new data to affect the 

classification. FDA agreed and 

continues to agree with the panel’s 

recommendation. The agency notes that 

the device has fallen into disuse and 

that the published data are not adequate 

to demonstrate the safety and 

effectiveness of the device. 

3. Risks to Health 

a. Pregnancy—Leakage, breakage, 

dislodgement, or displacement of the 

device during sexual intercourse could 

result in the occurrence of an undesired 

pregnancy. 

b. Transmission of infection 

(disease)—If the device fails due to 

leakage, breakage, dislodgement, or 

displacement, contact with infected 

semen or vaginal secretions or mucosa 

could result in the transmission of 

STD’s, including human 

immunodeficiency virus (HIV) (causing 

acquired immunodeficiency syndrome 

(AIDS)). 

c. Adverse tissue reaction—Unless the 

biocompatibility of materials and 

substances compromising the device are 

tested, local tissue irritation and 

sensitization or systemic toxicity could 

occur when the vaginal pouch contacts 

the vaginal wall, cervical mucosa, and 

the penis. 

d. Ulceration and other physical 

trauma—Depending on the design of the 

device, use of the female condom may 

cause abrasions, lacerations, bleeding, 

or other adverse effects to the vaginal or 

penile tissue. 

D. Transilluminator for breast 

evaluation (21 CFR 892.1990) 

1. Identification 

A transilluminator, also known as a 

diaphanoscope or lightscanner, is an 

electrically powered device that uses 

low intensity emissions of visible light 

and near-infrared radiation 

(approximately 700 to 1050 nanometers 

(nm)), transmitted through the breast, to 

visualize translucent tissue for the 

diagnosis of cancer, other conditions, 

diseases, or abnormalities. 

2. Summary of Data 

The Obstetrics and Gynecology 

Devices Panel recommended that 

transilluminator devices for breast 

evaluation be classified into class III and 

subject to premarket approval to provide 

reasonable assurance of the safety and 

effectiveness of the device. The panel 

concluded that there were no published 

studies or clinical data demonstrating 

the safety and effectiveness of the 

device. The panel indicated that the 

device presents a potential unreasonable 

risk of illness or injury to the patient if 

the clinician relies on the device and 

that although the device’s illumination 

level, wavelength, and image quality 

can be controlled through tests and 

specifications, insufficient evidence 

exists to determine that special controls 

can be established to provide reasonable 

assurance of the safety and effectiveness 

of the device for its intended use. FDA 

has not received any new data to affect 

the classification. FDA agreed and 

continues to agree with the panel’s 

recommendation. The agency notes that 

the device has fallen into disuse and 

that the published data are not adequate 

to demonstrate the safety and 

effectiveness of the device. 

3. Risks to Health 

a. Missed or delayed diagnosis—As a 

result of the questionable device 

performance of breast transilluminators, 

missed or delayed diagnosis are the 


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most catastrophic risks to health for a 

woman. These devices depend on the 

users’ visual interpretation of their own 

breast illumination. One scenario may 

result when a woman incorrectly 

interprets her transillumination as a 

tumor and suffers the ensuing anxiety 

from her belief that she has a cancer. 

Another scenario may result when a 

woman incorrectly dismisses the 

findings of her transillumination and 

then suffers from a missed diagnosis or 

delayed diagnosis and delayed 

treatment. Ultimately, missed or 

delayed diagnoses could result in the 

need for more aggressive treatment and 

a potentially higher risk of death. 

b. Electrical shock—If a breast 

transilluminator is not designed 

properly, the user may receive an 

electrical shock. 

c. Optical radiation—Prolonged 

gazing directly into the light of a breast 

illuminator while engaged in ‘‘bright 

light mode’’ may result in retinal 

damage. 

V. PMA Requirements 

A PMA for these devices must include 

the information required by section 

515(c)(1) of the act. Such a PMA should 

also include a detailed discussion of the 

risks identified previously, as well as a 

discussion of the effectiveness of the 

device for which premarket approval is 

sought. In addition, a PMA must 

include all data and information on: (1) 

Any risks known, or that should be 

reasonably known, to the applicant that 

have not been identified in this 

document; (2) the effectiveness of the 

device that is the subject of the 

application; and (3) full reports of all 

preclinical and clinical information 

from investigations on the safety and 

effectiveness of the device for which 

premarket approval is sought. 

A PMA must include valid scientific 

evidence to demonstrate reasonable 

assurance of the safety and effectiveness 

of the device for its intended use (see 21 

CFR 860.7(c)(2)). Valid scientific 

evidence is ‘‘evidence from wellcontrolled investigations, partially 

controlled studies, studies and objective 

trials without matched controls, welldocumented case histories conducted by 

qualified experts, and reports of 

significant human experience with a 

marketed device, from which it can 

fairly and responsibly be concluded by 

qualified experts that there is reasonable 

assurance of the safety and effectiveness 

of a device under its conditions of use. 

* * * Isolated case reports, random 

experience, reports lacking sufficient 

details to permit scientific evaluation, 

and unsubstantiated opinions are not 

regarded as valid scientific evidence to 

show safety or effectiveness.’’ (21 CFR 

860.7(c)(2)). 

VI. PDP Requirements 

A PDP for any of these devices may 

be submitted instead of a PMA, and 

must follow the procedures outlined in 

section 515(f) of the act. A PDP must 

provide: (1) A description of the device, 

(2) preclinical trial information (if any), 

(3) clinical trial information (if any), (4) 

a description of the manufacturing and 

processing of the devices, (5) the 

labeling of the device, and (6) all other 

relevant information about the device. 

In addition, the PDP must include 

progress reports and records of the trials 

conducted under the protocol on the 

safety and effectiveness of the device for 

which the completed PDP is sought. 

VII. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES), either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

VIII. Opportunity To Request a Change 

in Classification 

Before requiring the filing of a PMA 

or notice of completion of a PDP for a 

device, FDA is required by section 

515(b)(2)(A)(i) through (b)(2)(A)(iv) of 

the act and 21 CFR 860.132 to provide 

an opportunity for interested persons to 

request a change in the classification of 

the device based on new information 

relevant to the classification. Any 

proceeding to reclassify the device will 

be under the authority of section 513(e) 

of the act. 

A request for a change in the 

classification of these devices is to be in 

the form of a reclassification petition 

containing the information required by 

21 CFR 860.123, including new 

information relevant to the classification 

of the device. 

The agency advises that to ensure 

timely filing of any such petition, any 

request should be submitted to the 

Division of Dockets Management (see 

ADDRESSES) and not to the address 

provided in § 860.123(b)(1). If a timely 

request for a change in the classification 

of these devices is submitted, the agency 

will, within 180 days after receipt of the 

petition, and after consultation with the 

appropriate FDA resources, publish an 

order in the Federal Register that either 

denies the request or gives notice of its 

intent to initiate a change in the 

classification of the device in 

accordance with section 513(e) of the 

act and 21 CFR 860.130 of the 

regulations. 

IX. Environmental Impact 

The agency has determined under 21 

CFR 25.30(h) 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. 

X. Analysis of Impacts 

FDA has examined the impacts of the 

proposed rule under Executive Order 

12866 and the Regulatory Flexibility Act 

(5 U.S.C. 601–612), 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 proposed rule is not a 

significant regulatory action as defined 

by 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. Because there have been no 

premarket submissions for these devices 

in the past 5 years and all of the affected 

devices have fallen into disuse, FDA has 

concluded that there is little or no 

interest in marketing these devices in 

the future. Therefore, the agency 

proposes to certify that the proposed 

rule, if issued as a final rule, would not 

have a significant economic impact on 

a substantial number of small entities. 

We specifically request detailed 

comment regarding the appropriateness 

of our assumptions regarding the 

potential economic impact of this 

proposed rule. 

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 


srobinson on DSKHWCL6B1PROD with PROPOSALS
Federal Register / Vol. 75, No. 164 / Wednesday, August 25, 2010 / Proposed Rules 52299 

million, using the most current (2009) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this proposed rule to result in any 1- 

year expenditure that would meet or 

exceed this amount. 

FDA proposes to certify that this 

proposed rule, if issued as a final rule, 

would not have a significant economic 

impact. We base this determination on 

an analysis of registration and listing 

and other data for the affected devices. 

Two of the devices affected by this 

proposed rule, the female condom and 

ventricular bypass device, have never 

appeared in FDA’s electronic 

registration and listing database. These 

devices were identified as 

preamendment devices, but since their 

classification, the agency has no record 

of them ever being marketed. In 

addition, these devices represent older 

technologies that have since been 

replaced by newer technologies, 

currently being marketed under a 

Premarket Approval Application, or 

PMA. 

One of the affected devices, 

pacemaker repair and replacement 

material, is a material that can be used 

in multiple devices that was last listed 

in 2001 and the agency is aware of no 

evidence that the device has been 

marketed since 1991. In addition, on the 

increasingly rare occasions when a 

pacemaker is repaired today, the repair 

is done with materials specific to the 

approved device. The final affected 

device, the breast transilluminator, was 

last listed in 2007 but FDA has never 

cleared a 510(k) for this type of device. 

Although this device was listed as 

recently as 2007, the device was never 

approved or cleared for marketing. This 

information is summarized in table 1 of 

this document as follows: 

TABLE 1.—SUMMARY OF ELECTRONIC REGISTRATION AND LISTING INFORMATION

Device Name Product Code 510(k) or 

PMA? Last Listed Last Marketed 

Replaced by 

Approved 

Technology? 

Female Condom OBY No Never Listed 1930s Yes 

Ventricular Bypass Device OKR No Never Listed No Record Yes 

Pacemaker Repair and Replacement KFJ No 2001 1991 Yes 

Breast Transillunator LEK No 2007 No Record No 

Based on our review of electronic 

product registration and listing and 

other data, FDA concludes that there is 

currently little or no interest in 

marketing the affected devices and that 

the proposed rule would not have a 

significant economic impact. We 

specifically request detailed comment 

regarding the appropriateness of our 

assumptions regarding the potential 

economic impact of this proposed rule. 

XI. Federalism 

FDA has analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. FDA 

has determined that the proposed rule, 

if finalized, would not contain policies 

that would 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, the agency tentatively 

concludes that the proposed 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. 

XII. Paperwork Reduction Act of 1995 

This proposed rule refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR 812 have been 

approved under OMB control number 

0910–0078; the collections of 

information in 21 CFR 807, subpart E 

have been approved under OMB control 

number 0910–0120; the collections of 

information in 21 CFR 814, subpart B 

have been approved under OMB control 

number 0910–0231; and the collections 

of information under 21 CFR 801 have 

been approved under OMB control 

number 0910–0485. 

XIII. Proposed Effective Date 

FDA is proposing that any final rule 

based on this proposal become effective 

12 months after the date of its 

publication in the Federal Register or at 

a later date if stated in the final rule. 

List of Subjects 21 CFR Parts 870, 884, 

and 892 

Medical devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, it is proposed that 

21 CFR parts 870, 884, and 892 be 

amended as follows: 

PART 870—CARDIOVASCULAR 

DEVICES 

1. The authority citation for 21 CFR 

part 870 continues to read as follows: 

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

360j, 371. 

2. Section 870.3545 is amended by 

revising paragraph (c) to read as follows: 

§ 870.3545 Ventricular bypass (assist) 

device. 

* * * * * 

(c) Date PMA or notice of completion 

of PDP is required. A PMA or notice of 

completion of a PDP is required to be 

filed with FDA on or before [date 90 

days after date of publication of the 

final rule in the Federal Register], for 

any ventricular bypass (assist) device 

that was in commercial distribution 

before May 28, 1976, or that has, on or 

before [date 90 days after date of 

publication of the final rule in the 

Federal Register], been found to be 

substantially equivalent to any 

ventricular bypass (assist) device that 

was in commercial distribution before 

May 28, 1976. Any other ventricular 

bypass (assist) device shall have an 

approved PMA or declared completed 

PDP in effect before being placed in 

commercial distribution. 

3. Section 870.3710 is amended by 

revising paragraph (c) to read as follows: 

§ 870.3710 Pacemaker repair or 

replacement material. 

* * * * * 

(c) Date PMA or notice of completion 

of PDP is required. A PMA or notice of 

completion of a PDP is required to be 

filed with FDA on or before [date 90 

days after date of publication of the 


srobinson on DSKHWCL6B1PROD with PROPOSALS
52300 Federal Register / Vol. 75, No. 164 / Wednesday, August 25, 2010 / Proposed Rules 

final rule in the Federal Register], for 

any pacemaker repair or replacement 

material device that was in commercial 

distribution before May 28, 1976, or that 

has, on or before [date 90 days after date 

of publication of the final rule in the 

Federal Register], been found to be 

substantially equivalent to any 

pacemaker repair or replacement 

material device that was in commercial 

distribution before May 28, 1976. Any 

other pacemaker repair or replacement 

material device shall have an approved 

PMA or declared completed PDP in 

effect before being placed in commercial 

distribution. 

PART 884—OBSTETRICAL AND 

GYNECOLOGICAL DEVICES 

4. The authority citation for 21 CFR 

part 884 continues to read as follows: 

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

360j, 371. 

5. Section 884.5330 is amended by 

revising paragraph (c) to read as follows: 

§ 884.5330 Female condom. 

* * * * * 

(c) Date PMA or notice of completion 

of PDP is required. A PMA or notice of 

completion of a PDP is required to be 

filed with FDA on or before [date 90 

days after date of publication of the 

final rule in the Federal Register], for 

any female condom that was in 

commercial distribution before May 28, 

1976, or that has, on or before [date 90 

days after date of publication of the 

final rule in the Federal Register], been 

found to be substantially equivalent to 

any female condom that was in 

commercial distribution before May 28, 

1976. Any other female condom shall 

have an approved PMA or declared 

completed PDP in effect before being 

placed in commercial distribution. 

PART 892—RADIOLOGY DEVICES 

6. The authority citation for 21 CFR 

part 892 continues to read as follows: 

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

360j, 371. 

7. Section 892.1990 is amended by 

revising paragraph (c) to read as follows: 

§ 892.1990 Transilluminator for breast 

evaluation. 

* * * * * 

(c) Date PMA or notice of completion 

of PDP is required. A PMA or notice of 

completion of a PDP is required to be 

filed with FDA on or before [date 90 

days after date of publication of the 

final rule in the Federal Register], for 

any transilluminator for breast 

evaluation that was in commercial 

distribution before May 28, 1976, or that 

has, on or before [date 90 days after date 

of publication of the final rule in the 

Federal Register], been found to be 

substantially equivalent to any 

transilluminator for breast evaluation 

that was in commercial distribution 

before May 28, 1976. Any other 

transilluminator for breast evaluation 

shall have an approved PMA or 

declared completed PDP in effect before 

being placed in commercial 

distribution. 

Dated: August 19, 2010. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2010–21142 Filed 8–24–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 253 

[Docket No. 0908061221–91225–01] 

RIN 0648–AY16 

Merchant Marine Act and MagnusonStevens Fishery Conservation and 

Management Act Provisions; Fishing 

Vessel, Fishing Facility and Individual 

Fishing Quota Lending Program 

Regulations; Correction 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Proposed rule, correction and 

reopening of comment period. 

SUMMARY: NMFS published a proposed 

rule on May 5, 2010, amending the 

Fisheries Finance Program’s 

programmatic regulations. The proposed 

rule was published with an incorrect 

Regulatory Identification Number (RIN) 

in the ADDRESSES section. Members of 

the public using the incorrect RIN may 

have had difficulty posting comments at 

http://www.regulations.gov. In order to 

allow anyone adversely affected by the 

mistake to submit comments, NMFS 

reopens the comment period and 

requests additional comments for two 

weeks. 

DATES: NMFS invites the public to 

comment on the proposed rule 

published at 75 FR 24549. Comments 

must be submitted in writing on or 

before September 8, 2010. 

ADDRESSES: You may submit comments 

on the proposed rule, identified by RIN 

0648–AY16 by any one of the following 

methods: 

• Electronic Submissions: Submit all 

electronic public comments via the 

Federal eRulemaking Portal at http:// 

www.regulations.gov. 

• Fax: (301) 713–1306, Attn: Earl 

Bennett. 

• Mail: Earl Bennett, Acting Chief, 

Financial Services Division, NMFS, 

Attn: F/MB5, 1315 East-West Highway, 

SSMC3, Silver Spring, MD 20910. 

Instructions: All comments received 

are a part of the public record and will 

generally be posted to http:// 

www.regulations.gov without change. 

All Personal Identifying Information (for 

example, name, address, etc.) 

voluntarily submitted by the commenter 

may be publicly accessible. Do not 

submit Confidential Business 

Information or otherwise sensitive or 

protected information. 

NMFS will accept anonymous 

comments (enter N/A in the required 

fields if you wish to remain 

anonymous). Attachments to electronic 

comments will be accepted in Microsoft 

Word, Excel, WordPerfect, or Adobe 

PDF file formats only. Written 

comments regarding the burden-hour 

estimates or other aspects of the 

collection-of-information requirements 

contained in this proposed rule may be 

submitted to earl.bennett@noaa.gov or 

david.rostker@omb.eop.gov or faxed to 

(202) 395–7285. 

FOR FURTHER INFORMATION CONTACT: Earl 

Bennett, (301) 713–2390 x 187, 

earl.bennett@noaa.gov. 

SUPPLEMENTARY INFORMATION: 

Need for Correction 

On May 5, 2010, NMFS published a 

proposed rule at 75 FR 24549, which 

can be viewed at http:// 

www.fakr.noaa.gov/prules/ 

75fr24549.pdf. 

The ADDRESSES section of the 

proposed rule contained an incorrect 

RIN. Although members of the public 

submitting comments by mail, fax and 

e-mail to the addresses listed in the 

proposed rule would have been 

unaffected, those attempting to post 

comments at http://www.regulations.gov 

may have been hindered from posting 

comments because of this error. In order 

to allow anyone adversely affected by 

the mistake the opportunity to 

comment, NMFS will take comments for 

an additional two weeks. 

The new sentence in the ADDRESSES

section of column one in 75 FR 24550 

should read: ‘‘You may submit 

comments, identified by 0648–AY16, by 

any one of the following methods:’’ 


srobinson on DSKHWCL6B1PROD with PROPOSALS