[Federal Register Volume 75, Number 164 (Wednesday, August 25, 2010)]
[Proposed Rules]
[Pages 52294-52300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-21142]
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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