48058 Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Proposed Rules 

FIGURE 2 TO PART 1130—BACK OF 

REGISTRATION FORM 

Dated: August 2, 2011. 

Todd A. Stevenson, 

Secretary, U.S. Consumer Product Safety 

Commission. 

[FR Doc. 2011–19912 Filed 8–5–11; 8:45 am] 

BILLING CODE 6355–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 870 

[Docket No. FDA–2011–N–0505] 

Effective Date of Requirement for 

Premarket Approval for Cardiovascular 

Permanent Pacemaker Electrode 

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 class III 

preamendments device: Cardiovascular 

permanent pacemaker electrode. 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 

this device to meet the statute’s 

approval requirements and the benefits 

to the public from the use of the device. 

In addition, FDA is announcing the 

opportunity for interested persons to 

request that the Agency change the 

classification of the cardiovascular 

permanent pacemaker electrode based 

on new information. This action 

implements certain statutory 

requirements. 

DATES: Submit either electronic or 

written comments by November 7, 2011. 

Submit requests for a change in 

classification by August 23, 2011. 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 XI of this 

document for the proposed effective 

date of any final rule that may publish 

based on this proposal. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2011–N– 

0505, by any of the following methods: 

Electronic Submissions 

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 No. FDA–2011–N–0505 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(s), 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: 

Elias Mallis, Food and Drug 

Administration, Center for Devices and 

Radiological Health, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 1538, 

Silver Spring, MD 20993–0002, 301– 

796–6216. 

SUPPLEMENTARY INFORMATION: 

I. Background—Regulatory Authorities 

The Federal Food, Drug, and Cosmetic 

Act (the FD&C Act), as amended by the 

Medical Device Amendments of 1976 

(the 1976 amendments) (Pub. L. 94– 

295), the Safe Medical Devices Act of 

1990 (the SMDA) (Pub. L. 101–629), and 

the Food and Drug Administration 

Modernization Act of 1997 (FDAMA) 

(Pub. L. 105–115), the Medical Device 

User Fee and Modernization Act of 2002 

(Pub. L. 107–250), the Medical Devices 

Technical Corrections Act (Pub. L. 108– 

214), and the Food and Drug 

Administration Amendments Act of 

2007 (Pub. L. 110–85), establish a 

comprehensive system for the regulation 

of medical devices intended for human 

use. Section 513 of the FD&C Act (21 

U.S.C. 360c) established three categories 

(classes) of devices, 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 FD&C 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 FD&C 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 

FD&C Act, to a predicate device that 

does not require premarket approval. 

The Agency determines whether new 

devices are substantially equivalent to 

predicate devices by means of 

premarket notification procedures in 

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

U.S.C. 360(k)) and 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 PMA until FDA 

issues a final regulation under section 

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

360e(b)) requiring premarket approval. 

Section 515(b)(1) of the FD&C 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 FD&C 

Act, whichever is later. Also, a 

preamendments device subject to the 

rulemaking procedure under section 

515(b) of the FD&C Act is not required 

to have an approved investigational 


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Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Proposed Rules 48059 

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 FD&C 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 FD&C 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 60 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 FD&C Act. 

Section 515(b)(3) of the FD&C 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 FD&C Act, unless 

the reason for termination is that the 

device is a banned device under section 

516 of the FD&C 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 FD&C 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 

FD&C 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 

be deemed adulterated under section 

501(f) of the FD&C 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 FD&C Act, and 

subject to seizure and condemnation 

under section 304 of the FD&C 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 FD&C Act (21 

U.S.C. 332), and the individuals 

responsible for such shipment will be 

subject to prosecution under section 303 

of the FD&C 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 device that 

is the subject of this regulation. 

The FD&C 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 

FD&C 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 FD&C 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 

FD&C 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 

the device. 

II. Dates New Requirements Apply 

In accordance with section 515(b) of 

the FD&C 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 

FD&C 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), 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 

§ 812.30. FDA, therefore, cautions that 

IDE applications should be submitted to 

FDA at least 30 days before the end of 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
48060 Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Proposed Rules 

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 

FD&C 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 this device have an 

approved PMA or a declared completed 

PDP, and (2) the benefits to the public 

from the use of the device. 

These findings are based on the 

reports and recommendations of the 

advisory committee (panel) for the 

classification of this device 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 this 

device type can be found in the 

following proposed and final rules and 

notices published in the Federal 

Register on these dates: (45 FR 7907 at 

7971, February 5, 1980; 52 FR 17736, 

May 11, 1987; and 60 FR 41986, August 

14, 1995). 

IV. Device Subject to This Proposal 

Cardiovascular Permanent or 

Temporary Pacemaker Electrode; 

Permanent Pacemaker Electrode (21 

CFR 870.3680(b)). 

A. Identification 

A permanent pacemaker electrode is a 

device consisting of flexible insulated 

electrical conductors with one end 

connected to an implantable pacemaker 

pulse generator and the other end 

applied to the heart. The device is used 

to transmit a pacing electrical stimulus 

from the pulse generator to the heart 

and/or to transmit the electrical signal 

of the heart to the pulse generator. 

B. Summary of Data 

The Cardiovascular Devices 

Classification Panel recommended that 

this device be classified into class III as 

permanent pacemaker electrodes are 

permanent implants providing lifesupporting or life-sustaining therapy. 

Over time, the devices that have been 

designed and developed have evolved 

and are widely variable from model to 

model as well as from manufacturer to 

manufacturer. These designs are 

generally more complex and of smaller 

sizes which may increase risk of failure 

and introduce new failure modes. 

Accordingly, this has limited the ability 

to develop comprehensive performance 

standards which would apply to all 

aspects of pacemaker lead design, 

testing, and use. Adequate performance 

standards have not yet been developed. 

The potential safety and effectiveness 

risks, unsuitability of general and 

special controls, long-term use as 

permanent implants of life-sustaining 

therapy, and documented field failures 

warrant classification of this device as 

class III. 

C. Risks to Health 

• Material risks. The material 

properties of pacemaker leads, 

including mechanical, electrical, 

biostability, biocompatibility, corrosion 

and other characteristics can affect acute 

and chronic performance. 

• Design risks. Lead designs may 

introduce features or geometries that 

depart from traditional designs, 

geometries, or sizes and which may 

result in degradation of performance 

and safety of use. 

• Manufacturing risks. Manufacturing 

variation, the introduction of more 

complex and smaller designs, or quality 

system failures may introduce device 

defects that may not be identified with 

bench testing or acute in vivo studies. 

• Clinical-use risks. 

Thromboembolism, perforation, tissue 

reaction (exit block), dislodgement, 

infection, air embolism, muscle/nerve 

stimulation, stenosis, and erosion/ 

extrusion may occur as a result of the 

clinical use and/or device malfunction. 

V. PMA Requirements 

A PMA for this device must include 

the information required by section 

515(c)(1) of the FD&C 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 

§ 860.7(c)(2) (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, 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.’’ 

(§ 860.7(c)(2)). 

VI. PDP Requirements 

A PDP for this device may be 

submitted instead of a PMA, and must 

follow the procedures outlined in 

section 515(f) of the FD&C 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 

device; (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. 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 FD&C 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 FD&C 

Act. 

A request for a change in the 

classification of this device is to be in 

the form of a reclassification petition 

containing the information required by 

§ 860.123 (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 this device is submitted, the Agency 

will, within 60 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 


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Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Proposed Rules 48061 

classification of the device in 

accordance with section 513(e) of the 

FD&C Act and § 860.139 (21 CFR 

860.130) of the regulations. 

VIII. 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. 

IX. Analysis of Impacts 

FDA has examined the impacts of the 

proposed rule under Executive Order 

12866, Executive Order 13563, the 

Regulatory Flexibility Act (5 U.S.C. 

601–612), and the Unfunded Mandates 

Reform Act of 1995 (Pub. L. 104–4). 

Executive Orders 12866 and 13563 

direct 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 Executive Order 12866. 

The Regulatory Flexibility Act 

requires Agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because none of the 

manufacturers of affected products are 

small businesses, the Agency proposes 

to certify that the final rule would not 

have a significant economic impact on 

a substantial number of small entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that Agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $136 

million, using the most current (2010) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this proposed rule to result in any oneyear expenditure that would meet or 

exceed this amount. 

A. Costs of the Proposed Rule 

Under the proposed rule, FDA would 

require producers in the cardiovascular 

permanent pacemaker electrode 

industry to obtain PMA or establish a 

PDP before marketing new products. 

Similarly, producers of cardiovascular 

permanent pacemaker electrodes that 

are already on the market would need 

to submit PMA applications or establish 

PDPs in order to continue commercial 

distribution of these products. Based on 

an analysis of registration and listing 

data, manufacturer Web sites, and 

responses to previous Federal Register 

requests for comment; FDA estimates 

that 5 to 10 manufacturers are marketing 

approximately 18 to 23 devices that 

would be affected by this proposed rule. 

We therefore estimate that the proposed 

rule would generate between 18 and 23 

PMA or PDP submissions. FDA has 

estimated an upper bound on the cost of 

PMA at approximately $1,000,000 (see, 

for example, 73 FR 7501, February 8, 

2008), and we assume that the cost of a 

PDP is roughly equal to that of a PMA; 

this yields a rule-induced upfront cost 

of between $18 and $23 million. We 

lack data with which to estimate how 

the burden of this cost would be 

distributed among device 

manufacturers, patients and insurance 

providers. 

For a new product (i.e., a 

cardiovascular permanent pacemaker 

electrode not currently on the market), 

the rule-induced cost would be the 

difference between the cost of preparing 

and submitting a premarket approval 

application and the cost of preparing 

and submitting a 510(k) application. 

However, FDA has not received any 

submissions for new devices of the type 

subject to the proposed rule since 

August 2004. We expect the recent 

pattern of zero submissions to continue; 

therefore, the proposed rule would not 

generate submission costs on an ongoing 

basis. 

Some producers of devices that are 

subject to the proposed rule could be 

dissuaded from seeking approval by the 

cost of submitting a PMA application or 

by a low expectation that FDA would 

grant approval for their products. In 

these cases, producers would 

experience a rule-induced cost equal to 

the foregone expected profit on the 

withdrawn or withheld cardiovascular 

permanent pacemaker electrodes, which 

is necessarily less than the cost of PMA 

submission (otherwise, the producers in 

question would not be dissuaded from 

seeking PMA). Additionally, there 

would be a welfare loss experienced by 

consumers who would, in the absence 

of the proposed rule, use the 

cardiovascular permanent pacemaker 

electrodes that would be withdrawn or 

withheld from the market as a result of 

the call for PMA or PDP. Due to the lack 

of sufficient market data, we cannot 

quantify these consumers’ welfare loss. 

FDA requests comment on this issue 

and on all methods and results of our 

cost estimation. 

In addition to the cost to industry of 

preparing and submitting PMAs or 

PDPs, the proposed rule would impose 

incremental review costs on FDA. 

Geiger (2005) (Ref. 1) estimated that, for 

devices reviewed by FDA’s Center for 

Devices and Radiological Health in 2003 

and 2004, review costs averaged 

$563,000 per PMA. Updated for 

inflation (using U.S. Department of 

Commerce, 2011) (Ref. 2) to 2010 

dollars, this average review cost 

becomes $653,000 per PMA. Thus, the 

proposed rule’s review-related costs are 

expected to be between $11.8 million 

(18 × $653,000) and $15.0 million (23 × 

$653,000). A portion of this total would 

be paid by industry in the form of user 

fees, with the remainder coming from 

general revenues. FDA’s Data universal 

numbering system database reveals that 

the manufacturers affected by this 

proposed rule have annual revenues 

over $100 million, so they would not be 

eligible for small business user fees. The 

standard user fee is currently set at 

$236,298 for a premarket application 

(PMA or PDP) (75 FR 45632 at 45643), 

so user fees would likely cover $4.3 

million (= 18*$236,298) to $5.4 million 

(= 23*$236,298) of FDA review costs, 

with the remaining $7.5 to $9.6 million 

coming from general revenues. 

B. Benefits of the Proposed Rule 

The proposed requirement for 

premarket approval applications or 

product development protocols for 

cardiovascular permanent pacemaker 

electrodes would produce social 

benefits equal to the value of the 

information generated by the safety and 

effectiveness tests that producers would 

be required to conduct as part of the 

PMA or PDP process. Provided first to 

FDA, this information would eventually 

assist physicians, patients and 

insurance providers in making more 

informed decisions about these devices. 

FDA expects there to be approximately 

18 to 23 PMA or PDP submissions as a 

result of the proposed rule, but we are 

unable to quantify the value of 

information associated with each 

submission. We request comment on 

this issue. 

X. 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 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
48062 Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Proposed Rules 

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

of information in 21 CFR part 812 have 

been approved under OMB control 

number 0910–0078; the collections of 

information in 21 CFR part 807, subpart 

E have been approved under OMB 

control number 0910–0120; the 

collections of information in 21 CFR 

part 814, subpart B have been approved 

under OMB control number 0910–0231; 

and the collections of information under 

21 CFR part 801 have been approved 

under OMB control number 0910–0485. 

XI. Proposed Effective Date 

FDA is proposing that any final rule 

based on this proposal become effective 

on the date of its publication in the 

Federal Register or at a later date if 

stated in the final rule. 

XII. 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. 

XIII. References 

The following references have been 

placed on display in the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852, 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. (FDA has verified the 

Web site address, but FDA is not 

responsible for any subsequent changes 

to the Web site after this document 

publishes in the Federal Register.) 

1. Geiger, Dale R, ‘‘FY 2003 and 2004 Unit 

Costs for the Process of Medical Device 

Review,’’ September 2005, http://www.

fda.gov/downloads/MedicalDevices/

DeviceRegulationandGuidance/

Overview/MedicalDeviceUserFeeand

ModernizationActMDUFMA/umc109216. 

2. U.S. Department of Commerce, Bureau of 

Economic Analysis, National Income and 

Product Accounts Table 1.1.9, http:// 

www.bea.gov/national/nipaweb/ 

SelectTable.asp, accessed March 25, 

2011. 

List of Subjects in 21 CFR Part 870 

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 part 870 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 870.3680 is amended by 

revising paragraph (c) to read as follows: 

§ 870.3680 Cardiovascular permanent or 

temporary pacemaker electrode. 

* * * * * 

(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 the Food and Drug 

Administration on or before [A DATE 

WILL BE ADDED 90 DAYS AFTER 

DATE OF PUBLICATION OF A 

FUTURE FINAL RULE IN THE 

FEDERAL REGISTER], for any 

permanent pacemaker electrode that 

was in commercial distribution before 

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

[A DATE WILL BE ADDED 90 DAYS 

AFTER DATE OF PUBLICATION OF A 

FUTURE FINAL RULE IN THE 

FEDERAL REGISTER], been found to be 

substantially equivalent to any 

permanent pacemaker electrode that 

was in commercial distribution before 

May 28, 1976. Any other permanent 

pacemaker electrode shall have an 

approved PMA or declared completed 

PDP in effect before being placed in 

commercial distribution. 

Dated: August 2, 2011. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2011–19959 Filed 8–5–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 882 

[Docket No. FDA–2011–N–0504] 

Effective Date of Requirement for 

Premarket Approval for Cranial 

Electrotherapy Stimulator 

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 Cranial 

Electrotherapy Stimulator. 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 this 

device to meet the statute’s approval 

requirements and the benefits to the 

public from the use of the device. In 

addition, FDA is announcing the 

opportunity for interested persons to 

request that the Agency change the 

classification of the cranial 

electrotherapy stimulator based on new 

information. This action implements 

certain statutory requirements. 

DATES: Submit either electronic or 

written comments by November 7, 2011. 

Submit requests for a change in 

classification by August 23, 2011. 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 XII 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–2011–N– 

0504 by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following ways: 

• 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 No. FDA–2011–N–0504 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. 


emcdonald on DSK2BSOYB1PROD with PROPOSALS