Document ID: FDA-2010-N-0412-0001
Agency: fda
Document Type: Proposed Rule
Title: Effective Date of Requirement for Premarket Approval for Four Class III Preamendments Devices
Posted Date: 2010-08-25T04:00Z

[Federal Register: August 25, 2010 (Volume 75, Number 164)]
[Proposed Rules]               
[Page 52294-52300]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25au10-21]                         

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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.

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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

[[Page 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

[[Page 52296]]

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 Sec.  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 Sec.  
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

[[Page 52297]]

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 
life-sustaining 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

[[Page 52298]]

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 well-controlled investigations, partially controlled 
studies, studies and objective trials without matched controls, well-
documented 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 Sec.  
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

[[Page 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
----------------------------------------------------------------------------------------------------------------
                                                                                                    Replaced by
           Device Name             Product Code   510(k) or PMA?    Last Listed    Last Marketed     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:

Sec.  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:

Sec.  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

[[Page 52300]]

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:

Sec.  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:

Sec.  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