[Federal Register Volume 72, Number 74 (Wednesday, April 18, 2007)]
[Notices]
[Pages 19528-19534]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-1919]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0068]


Medical Device User Fee and Modernization Act; Public Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public meeting.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is announcing a public 
meeting to discuss our proposed recommendations for the reauthorization 
of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA I) 
for fiscal years (FY) 2008 through 2012, as well as other proposals to 
improve the review of medical devices and the third party inspection 
program. These proposed recommendations were developed after 
discussions with the regulated industry. Section 105 of MDUFMA I 
directs FDA to publish these proposed recommendations in the Federal 
Register, hold a meeting at which the public may present its views on 
the recommendations, and provide for a period of 30 days for the public 
to provide written comments on the recommendations. The public meeting 
and comment period will provide an opportunity for public input on the 
proposed recommendations from all interested parties, including the 
regulated industry, scientific and academic experts, healthcare 
professionals, and representatives of patient and consumer advocacy 
groups.

DATES:  The public meeting will be held on April 30, 2007, from 12 noon 
to 5 p.m. Registration to attend and to present at the meeting must be 
received by April 25, 2007. (See section III.B of this document for 
details on registration.) Submit written comments by May 18, 2007. 
Transcripts will be available approximately 30 days after the meeting. 
(See section III.C of this document for more details on transcript 
availability.)

ADDRESSES:  The public meeting will be held at the Food and Drug 
Administration, 5630 Fishers Lane, rm. 1066, Rockville, MD 20857. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: For information regarding this notice, 
contact: Erik Mettler, Office of Policy and Planning, Food and Drug 
Administration (HF-11), 5600 Fishers Lane, Rockville, MD 20857, 301-
827-3360, FAX: 301-594-6777, e-mail: [email protected].
    For information regarding registration, contact: Cynthia Garris, 
Office of Communication, Education, and Radiation Programs, Center for 
Devices and Radiological Health, Food and Drug Administration (HFZ-
220), 1350 Piccard Ave., Rockville, MD 20850, phone: 240-276-3150 ext. 
121, FAX: 240-276-3151; e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Introduction

    MDUFMA I (Public Law 107-250, October 26, 2002) amended the Federal 
Food, Drug, and Cosmetic Act (the act) to provide FDA with the 
following new responsibilities and resources:
     User fees for premarket reviews of certain device 
premarket applications (see sections 737 and 738 of the act (21 U.S.C. 
379i and 379j));
     Performance goals to improve medical device reviews (see 
section 101(3) of MDUFMA I and section 738(g)(1) of the act);
     Establishment inspections to be conducted by accredited 
third-parties when certain conditions are met (see section 704(g) of 
the act (21 U.S.C. 374)); and
     Improved oversight and coordination of reviews of 
combination products (products that combine devices, drugs, or 
biologics) (see section 503(g) of the act (21 U.S.C. 353(g))).

A. Medical Device User Fees and Performance Goals

    In the years prior to MDUFMA I, FDA's resources for our device and 
radiological health programs had increased at a lower rate than FDA's

[[Page 19529]]

costs. As stated in the House Report to H.R. 3580:
    The medical device industry is growing rapidly. The complexity of 
medical device technology is increasing at an equally rapid pace. 
Unfortunately, FDA's device review program lacks the resources to keep 
up with the rapidly growing industry and changing technology. Because 
prompt approval and clearance of safe and effective medical devices is 
critical to improving public health, it is the sense of the Committee 
that adequate funding for the program is essential. (U.S. Congress, 
House Committee on Energy and Commerce, Medical Device User Fee and 
Modernization Act of 2002, report to accompany H.R. 3580, 107th Cong., 
2nd sess., part 1 (Washington: GPO, 2002), pp. 23.)
    Section 102 of the House Report recognized the importance of user 
fees in improving the device review program:
    This title gives FDA the authority to collect user fees from 
manufacturers seeking to market medical devices. In this new program, 
manufacturers pay fees to FDA in exchange for FDA's agreement to 
endeavor to meet device review performance goals that will 
significantly improve the timeliness, quality, and predictability of 
the agency's review of devices. (Id. at 23-24.)
    Under MDUFMA I, the industry provides funds through user fees that 
are available to FDA, in addition to appropriated funds, to spend on 
the device review process. Our authority to collect and spend user fees 
is ``triggered'' only in years when a base amount of appropriated 
funds, adjusted for inflation, is appropriated and spent on the process 
for the review of device applications.
    In return for the additional resources provided by medical device 
user fees, FDA is expected to meet performance goals defined in a 
November 14, 2002, letter from the Secretary of the Department of 
Health and Human Services to the Chairman and Ranking Minority Members 
of the Committee on Health, Education, Labor and Pensions Committee of 
the U.S. Senate and the Committee on Energy and Commerce of the U.S. 
House of Representatives. This letter is generally referred to as the 
``FDA Commitment Letter.'' See 148 Cong. Rec. S11549-01 (2002). A few 
goals applied during FY 2003 and FY 2004, allowing FDA time to hire 
staff, build infrastructure, provide guidance to industry, and take 
other actions to implement the new law. More goals went into effect 
each year from FY 2005 through FY 2007, and the goals become more 
ambitious each year. These goals include ``FDA decision'' goals, under 
which FDA makes a specific decision within a specified time (and 
similar goals for FDA to ``review and act on'' certain biologics 
applications within a specified time), and cycle goals, which refer to 
FDA actions prior to a final action on a submission. These goals apply 
to the review of device premarket approvals (PMAs), panel-track 
supplements, premarket reports, expedited PMAs, 180-day PMA 
supplements, and 510(k)s in FDA's Center for Devices and Radiological 
Health (CDRH) and FDA's Center for Biologics Evaluation and Research 
(CBER), and to Biologics License Applications (BLAs), BLA supplements, 
and BLA resubmissions, and BLA supplement resubmissions in CBER. Phased 
in over the 5 years of MDUFMA I, the final goals for FY 2007 included 
an FDA decision on:
     90 percent of PMAs, panel-track supplements, and premarket 
reports within 320 days;
     50 percent of PMAs, panel-track supplements, and premarket 
reports within 180 days;
     90 percent of expedited PMAs within 300 days;
     90 percent of 180-day PMA supplements within 180 days;
     80 percent of 510(k)s within 90 days;
     90 percent of standard BLAs within 10 months;
     90 percent of priority BLAs within 6 months;
     90 percent of standard BLA efficacy supplements in 10 
months;
     90 percent of priority BLA efficacy supplements within 6 
months;
     90 percent of ``Class 1'' BLA resubmissions and BLA 
supplement resubmissions within 2 months;
     90 percent of ``Class 2'' BLA resubmissions and BLA 
supplement resubmissions within 6 months; and
     90 percent of BLA manufacturing supplements requiring 
prior approval within 4 months.
    The goals also included interim cycle goals that were phased in 
over time. FDA is on track to meet or exceed nearly all of these 
performance goals. These performance goals, as outlined in the FDA 
Commitment Letter, will no longer be in effect after MDUFMA I sunsets 
on October 1, 2007. See section 107 of MDUFMA I.

B. Other Topics in MDUFMA I

    In addition to its provisions relating to medical device user fees 
and performance goals, MDUFMA I contained other provisions. These 
provisions include:
     Authorization for a program that allows establishment 
inspections to be conducted by third party accredited persons (APs), 
under carefully prescribed conditions;
     Establishment of a new office in the Office of the 
Commissioner to coordinate the review of combination products;
     Authorization to require electronic registration of device 
establishments, once FDA finds that electronic registration is 
feasible; and
     Explicit authorization for the ``modular'' review of PMAs.
    The user fees provided by MDUFMA I, and the additional 
appropriations anticipated by the new law, have allowed us to make 
improvements in the device review program. FDA's progress towards 
meeting MDUFMA I's performance goals has been accomplished through:
     Targeted hiring, including medical specialists, 
statisticians, software experts, and engineers;
     Increased use of outside experts, particularly for novel 
technologies;
     Improvements to FDA's information technology systems, such 
as enhanced tracking of applications and reporting systems; and
     Additional guidance documents that assist industry in 
preparing their applications to better address regulatory issues, such 
as how to qualify for small business fee waivers and discounts, how to 
prepare a ``modular'' premarket approval application, and how to obtain 
expedited review of a premarket submission.
    These actions have led to improved FDA review times and greater 
predictability in the device review process.
    In addition, we have made significant progress towards meeting 
other fundamental objectives of MDUFMA I. For example, FDA established 
an Office of Combination Products that is improving coordination of 
combination product reviews. Combination products are products 
comprised of different types of regulated articles (i.e., drug-device, 
drug-biologic, and device-biologic products). Although primary 
responsibility for the oversight of these products remains with the 
product Centers, the Office of Combination Products assigns combination 
products to the product Centers, ensures the timely and effective 
premarket review of combination products, and ensures the consistency 
and appropriateness of postmarket regulation of combination products. 
FDA also met the statutory requirement to establish a third-party 
inspection program. This option may be particularly useful to U.S. 
firms who

[[Page 19530]]

compete in international markets and are faced with multiple sets of 
regulatory requirements, as a single inspection may satisfy both U.S. 
and foreign requirements, and might also meet International 
Organization for Standardization (ISO) or other international standards 
requirements.
    In August 2005, Congress passed the Medical Device User Fee 
Stabilization Act (Public Law 109-43, August 1, 2005) (MDUFSA), which 
modified several provisions of MDUFMA I.
    MDUFSA:
     Repealed the FY 2003 and FY 2004 appropriations trigger 
requirements;
     Modified the FY 2005 through FY 2007 minimum appropriation 
requirements for the device and radiological health line of FDA's 
appropriation to be within 1 percent below the calculated 
appropriations trigger;
     Fixed annual fees for FY 2006 and FY 2007 at an amount 
providing an 8.5 percent rate of increase each year;
     Expanded the definition of ``small business'' for FY 2006 
and FY 2007, making more firms eligible for reduced small business 
fees; and
     Repealed the ``compensating adjustment'' that allowed FDA 
to adjust user fee rates to make up for revenue lost when user fee 
revenues did not meet projections in a prior year.
    The user fee provisions of MDUFMA I will sunset on October 1, 2007 
if not reauthorized. In preparing our proposed recommendations for 
reauthorization, we have conducted technical discussions with the 
regulated industry and have consulted with stakeholders each year at a 
public meeting as required by law.
    Congress directed FDA to publish in the Federal Register the 
proposed recommendations developed through this process after 
negotiations with the regulated industry, present the proposed 
recommendations to the congressional committees specified in the 
statute, hold a public meeting at which the public can present its 
views on the proposed recommendations, and provide for a period of 30 
days for the public to provide written comments on the proposed 
recommendations. See section 109 of MDUFMA I.
    The purpose of this notice is to publish the recommendations we 
propose to offer Congress and announce the dates for the upcoming 
public meeting and written comment period. After the public meeting and 
the close of the 30-day comment period, we will undertake a careful 
review of all the public comments we receive on these proposed 
recommendations.

II. What We Are Proposing to Recommend to Congress?

    Our goal for the legislative package to reauthorize medical device 
user fees and to make other improvements (MDUFMA II) is to build upon 
the performance goals we are pursuing for FY 2007 while providing 
predictable user fees for industry and financial stability and 
predictability in funding for FDA over the next 5 years. Our proposed 
recommendations fall into the following two major categories: (1) 
Proposals to ensure sound financial footing for the medical device 
review program and (2) proposals to enhance the process for premarket 
review of device applications.

A. Proposed Recommendations to Ensure Sound Financial Footing

    Although user fees have provided substantial resources to FDA since 
the beginning of the program, total resources for medical device 
review, including funds from both appropriations and user fees, have 
not kept up with our increasing costs. FDA has experienced an increase 
in our costs of pay and benefits per ``full time equivalent'' (FTE) 
averaging 5.8 percent per year over the most recent 5 years. Nonsalary 
costs, including the costs of rent and contract support, have also 
increased at the same rate per FTE. We are proposing changes to the 
financial provisions of MDUFMA I to place FDA on more sound financial 
footing so we can continue with the program and make enhancements to 
it.
1. Adjustment of Total Revenue for Device Review to Ensure a 6.4 
Percent Increase From Year to Year Over the Next 5 Years
    Detailed analysis of FDA's recent costs history and anticipated 
increased costs over the next 5 years anticipate annual increases at 
6.4 percent each year. Increases of 6.4 percent per year are necessary 
for FDA to be able to maintain the current level of staff to support 
the medical device review process. The primary drivers of this rate of 
increase are rent, security, and statutorily mandated payroll and 
benefits increases. In developing cost estimates for MDUFMA II, we used 
our FY 2005 spending on the device review process (including fees and 
appropriations) and estimated that the costs for the program would 
increase at 6.4 percent each year. Table 1 of this document represents 
FDA's estimate of the total resources it will need for device review 
from appropriations and user fees combined over the 5-year period 2008 
through 2012.

                   Table 1.--Total Resources Needed for the Device Review Process ($ Millions)
----------------------------------------------------------------------------------------------------------------
   Fiscal Year         2008            2009            2010            2011            2012        5-Year Total
----------------------------------------------------------------------------------------------------------------
Dollars                     $220            $234            $249            $265            $281          $1,249
 (millions)
----------------------------------------------------------------------------------------------------------------

    The annual fee increases assumed will ensure a stable program that 
will not increase over the 5 years of MDUFMA II, but that should remain 
stable in its capabilities and personnel strength. The proposed fee 
structure would have application fees lower than those paid in 2007 in 
almost all application categories over the 5 years of MDUFMA II, but 
would add new annual establishment and annual report fees and some new 
application fees (discussed more below). Total fee revenues in FY 2008 
would increase by approximately 31 percent over estimated FY 2007 fee 
revenues, and by 8.5 percent per year each subsequent year through FY 
2012, as shown in table 2 below.

                               Table 2.--Total Estimated Fee Revenues ($ Millions)
----------------------------------------------------------------------------------------------------------------
   Fiscal Year         2008            2009            2010            2011            2012        5-Year Total
----------------------------------------------------------------------------------------------------------------
Total                      $48.5           $52.5           $57.0           $61.9           $67.1          $287.0
----------------------------------------------------------------------------------------------------------------


[[Page 19531]]

2. More Stable Fee Structure
    All fee revenues in MDUFMA I were derived from application fees 
only, which fluctuated significantly from year to year. Under MDUFMA I, 
fee revenues repeatedly fell short of expectations. FDA is proposing to 
recommend two new fees in MDUFMA II that would generate about 50 
percent of the total fee revenue and that would be more stable than 
application fees. The new fees are: (1) An annual establishment 
registration fee and (2) an annual fee for filing periodic reports. 
This would allow for significant reduction in MDUFMA II of existing 
application fees.
    The establishment fee would be paid once each year by each device 
manufacturer (including an establishment that sterilizes or otherwise 
makes a device for a specification developer or any other person), 
single-use reprocessor, and specification developer. It is proposed to 
start at $1,706 in 2008 and would generate about $21.8 million (45 
percent of total fee revenues), assuming that 12,750 establishments pay 
this fee. (The proposal would allow an increase in FY 2010 over the 
annual rate of increase if fewer than 12,250 establishments pay the fee 
in FY 2009 to ensure that the fees collected from this source total 45 
percent of fee revenues. This increase would not be more than 8.5 
percent above the annual rate of increase.) A firm would not be 
considered to be legally registered each year without the payment of 
this fee, which is to be completed electronically.
    The annual fee for filing periodic reports is proposed to start at 
$6,475 in FY 2008 and would generate about $2.5 million in FY 2008, or 
about 5 percent of fee revenues assuming that we receive reports on 425 
devices subject to periodic reporting and 10 percent pay the reduced 
small business fee of $ 1,619.
    The remaining 50 percent of revenues would come from application 
fees. All proposed application fees would be significantly lower than 
they were in FY 2007. The proposed fee for a PMA or BLA would be set at 
$185,000 in FY 2008--34 percent less than the $281,600 charged in FY 
2007. The proposed fee for a panel-track supplement would be charged at 
75 percent of the rate for a PMA, rather than at 100 percent of that 
rate as was the case in FY 2003 through FY 2007, so the proposed panel-
track supplement fee in FY 2008 of $138,750 would be 51 percent less 
than the FY 2007 fee of $281,600. The fee for a 180-day PMA supplement 
is proposed at 15 percent of the PMA fee, rather than at 21.5 percent 
of that rate as was the case in FY 2003 through FY 2007, so the 
proposed 180-day PMA supplement fee in FY 2008 of $27,750 would be 54 
percent less than the FY 2007 fee of $60,544. The fee for a real-time 
supplement is proposed at 7 percent of the PMA fee, rather than at 7.2 
percent of that rate as was the case in FY 2003 through FY 2007, so the 
proposed real-time supplement fee in FY 2008 of $12,950 would be 36 
percent less than the FY 2007 fee of $20,275. The fee for a 510(k) is 
proposed at 1.84 percent of the PMA fee, rather than at 1.42 percent of 
that rate as was the case in FY 2003 through FY 2007, so the proposed 
510(k) fee in FY 2008 of $3,404 would be 18 percent less than the FY 
2007 fee of $4,158.
    FDA is proposing two new fees for applications not currently 
subject to fees. They are: (1) A fee for 30-day notices (making 
modifications to manufacturing procedures or methods) that would be 1.6 
percent of the fee for a full PMA (for a 30-day notice fee of $2,960 in 
FY 2008) and (2) a fee for a request for classification information 
under section 513(g) that would be assessed at 1.35 percent of the cost 
of a full PMA (for a 513(g) fee of $2,498 in FY 2008). Both of these 
applications require significant work by FDA, and the proposed fees 
reflect the work that they involve, on average.
    Each of the proposed fees would increase each year by 8.5 percent 
to ensure that fee revenues contribute their expected share to total 
program costs, and to provide industry with stability and 
predictability in the fee revenues it would expect to pay.
3. Changes in the Fee Structure for Small Businesses
    In an effort to reduce the burden on small businesses, FDA is 
proposing to reduce the rates paid by firms meeting the definition of a 
small business under MDUFMA. The criteria for meeting the small 
business definition is not proposed to change, other than as discussed 
below for entities that do not file returns with the U.S. Internal 
Revenue Service, but the proposed fee rates for qualifying small 
businesses would be lower. We are proposing to reduce the rates for 
small businesses for premarket applications, panel-track PMA 
applications, BLA efficacy supplements, 180-day PMA supplements, real-
time PMA supplements, and annual reports, from 38 percent to 25 percent 
of the standard fee for the particular type of submission. We are also 
proposing to reduce the rates for small businesses for 30-day notices, 
510(k) premarket notification submissions, and 513(g) requests for 
classification information from 80 percent to 50 percent of the 
standard fee for the particular type of submission. These are 
significant reductions that should provide substantial relief to 
qualifying small businesses.
    The following table summarizes the reductions in fees for 
qualifying small businesses proposed for FY 2008.

         Table 3.--Medical Device User Fees Proposed for FY 2008
------------------------------------------------------------------------
                                                          Small Business
               Type of Fee                 Standard Fee         Fee
------------------------------------------------------------------------
Premarket application (PMA, BLA,                $185,000         $46,250
 premarket report, product development
 protocol)
Panel-track PMA supplement                      $138,750         $34,688
180-day PMA supplement                           $27,750          $6,938
BLA efficacy supplement                         $185,000         $46,250
Real-time PMA supplement                         $12,950          $3,237
30-day notice                                     $2,960          $1,480
510(k) premarket notification submission          $3,404          $1,702
Request for classification information            $2,498          $1,249
------------------------------------------------------------------------

    In addition, FDA is proposing that the small business provisions be 
expanded to allow a way for firms that do not file tax returns with the 
U. S. Internal Revenue Service to also qualify for small business 
rates, based on certifications from the national taxing authorities 
where the firm and each of its affiliates file their taxes, and signed 
affidavits from the head of the firm or its chief financial officer and 
from each of its affiliates.

[[Page 19532]]

4. Technical Changes to Increase Administrative Efficiency of the User 
Fee Program
    We are proposing a change to the current offset provision of MDUFMA 
I. The current provision requires us to reduce fees in a subsequent 
year if collections in any year exceed the amount appropriated, but 
does not have a parallel provision to increase fees in a subsequent 
year if collections fall short of amounts appropriated from fees. The 
modification we are recommending to propose would allow us to aggregate 
all fees collected over the first four years of MDUFMA II, from FY2008 
through FY 2011 and compare that amount to the aggregate amount 
appropriated for the same period. A reduction would be made in fees in 
the final year only if the amount collected in the 4-year period 
exceeds the amount appropriated for the same period. We believe this 
aggregation over 4 years provides for greater financial stability for 
FDA than treating each year in isolation.
5. Electronic Registration
    FDA is proposing to change section 510(p) of the act (21 U.S.C. 
360(p)) to facilitate the submission of registration and listing 
information by electronic means, except in those rare situations where 
FDA agrees that electronic submission is not feasible, in order to 
collect establishment registration fees for FY 2008. The modification 
would require electronic submission of registration and listing 
information without going through the rulemaking process to ensure 
timely collection of establishment registration fees for FY 2008. We 
believe electronic registration is essential for efficient 
implementation of any proposal for an establishment registration fee.
6. Triggers
    MDUFMA I has three triggers. One tied to appropriations for the 
device line and two tied to agency spending on device review and 
inspections. We are proposing to extend the current triggers through 
MDUFMA II.

B. Enhancing the Process for Premarket Review

    In the area of premarket review, FDA is proposing to recommend 
enhancements in the following eight areas: (1) Performance goals; (2) 
interactive review; (3) guidance document development; (4) diagnostic 
imaging products; (5) in vitro diagnostics; (6) meetings; (7) quarterly 
performance reports; and (8) reviewer training.
1. Performance Goals
    FDA is proposing to meet more rigorous goals for MDUFMA II that 
build on the progress made in MDUFMA I. In making these proposals, we 
have taken into account the efficiencies accomplished in MDUFMA I and 
planned for in MDUFMA II. These efficiencies include additional 
scientific, regulatory, and leadership training; additional staff, 
including those with expertise demanded by increasingly complex device 
reviews; expanded use of outside experts; and information technology 
improvements that allow us to better track and manage the device review 
process.
    In MDUFMA II, we are proposing to eliminate the cycle goals that we 
believe are an impediment to reaching the ultimate objective of 
MDUFMA--to get safe and effective devices to patients and healthcare 
professionals more quickly. In order to meet the performance goals in 
the FDA Commitment Letter, we put business processes in place to meet 
the goals for final decisions, as well as for interim cycle goals. 
However, FDA believes that an unintended consequence of the cycle goals 
is that, because we must determine whether or not to send a major 
deficiency letter, ``not approvable'' letter, or other interim action 
earlier in the review process, we are less likely to have sufficient 
time to engage in informal interactions with the applicant to resolve 
outstanding questions before making that determination. Consequently, 
we are more likely to issue a negative interim decision. We are 
proposing to eliminate these cycle goals and only have performance 
goals for final decisions.
    In MDUFMA II, we are proposing to improve our performance in 
reaching a final decision for the following applications:
     A decision for 60 percent of nonexpedited PMAs and panel-
track PMA supplements within 180 days and for 90 percent within 295 
days;
     A decision for 50 percent of expedited PMAs and expedited 
panel-track PMA supplements within 180 days and for 90 percent within 
280 days;
     A decision for 90 percent of 510(k)s within 90 days and 
for 98 percent within 150 days;
     A decision for 85 percent of 180-day PMA supplements 
within 180 days and for 95 percent within 210 days;\1\ and
---------------------------------------------------------------------------

    \1\ Under MDUFMA I, FDA issues a ``not approvable'' letter to 
indicate deficiencies in an application and to request additional 
information, which counts as an action that meets the goals for 180-
day PMA supplements. Under MDUFMA II, the reviewer in the same 
situation will be able to issue a ``major deficiency'' letter, which 
will not count towards meeting the 180-day PMA supplement goals. The 
MDUFMA II goal will be more ambitious in practice because it 
reflects a more meaningful decision, reached after FDA has worked 
with the sponsor to discuss deficiencies and to obtain additional 
information.
---------------------------------------------------------------------------

     A decision for 80 percent of real-time PMA supplements 
within 60 days and for 90 percent within 90 days.
    We are also adding a goal for PMA modules in MDUFMA II. We are 
proposing to take action on 75 percent of PMA modules within 90 days, 
and for 90 percent within 120 days.
    Where specific quantitative goals have not been established, we are 
proposing that we would, at a minimum, maintain current performance in 
review areas, such as for investigational device exemptions (IDEs) and 
30-day notices.
2. Interactive Review
    Under the proposed recommendations, we would continue to 
incorporate an interactive review process to provide for, and 
encourage, informal communication between FDA and sponsors to 
facilitate timely completion of the review process based on accurate 
and complete information. Interactive review entails responsibilities 
for both FDA and sponsors. Interactive review is intended to: (a) 
Prevent unnecessary delays in the completion of the review; (b) avoid 
surprises to the sponsor at the end of the review process; (c) minimize 
the number of review cycles and the extent of review questions conveyed 
through formal requests for additional information; and (d) ensure 
timely responses from sponsors. We believe that all forms of 
communication should be used as tools to facilitate interactive review, 
including, but not limited to, the following: (a) E-mail; (b) one-on-
one telephone calls; (c) telephone conferences; (d) videoconferencing; 
(e) fax; and (f) face-to-face meetings.
3. Guidance Document Development
    Under the proposed recommendations, we would continue to develop 
guidance documents to the extent possible without adversely impacting 
the review timeliness for MDUFMA-related submissions. In addition, FDA 
would post a list of guidance documents it is considering for 
development and provide stakeholders an opportunity to provide comments 
and/or draft language for those topics as well as suggestions for new 
or different guidances.

[[Page 19533]]

4. Diagnostic Imaging Products
    Diagnostic imaging devices that are sometimes used concurrently 
with diagnostic drug and biological products (such as contrast agents 
and radiopharmaceuticals)--so-called ``concomitant use products''--
present important questions of efficient regulation and consultation 
between product Centers that are similar to those raised by combination 
products.
    In response to these concerns, FDA would develop a guidance 
document, after consultation with affected parties, intended to ensure 
timely and effective review of, and consistent and appropriate 
postmarket regulation and product labeling requirements for, diagnostic 
imaging devices used with approved imaging contrast agents and/or 
radiopharmaceuticals. We propose to publish draft guidance by the end 
of FY 2008 and allow for a 90-day public comment period. We propose to 
issue a final guidance within one year of the close of the comment 
period.
5. In Vitro Diagnostics (IVDs)
    To facilitate the development of IVD devices, FDA would continue to 
explore ways to clarify regulatory requirements and to reduce 
regulatory burden, as appropriate. FDA proposes to:
     Draft or revise guidance on the conduct of clinical trials 
involving de-identified leftover specimens, clinical trial design 
issues for molecular diagnostic tests, migration studies, herpes 
simplex virus, enterovirus, and influenza testing;
     Conduct a pilot program to evaluate integrating the 510(k) 
review and Clinical Laboratory Improvement Amendments (CLIA) waiver 
review processes for possible increased efficiencies. This pilot would 
include only voluntary participants from industry, and the applications 
involved in the pilot would not be counted toward the MDUFMA II 
performance goals.
     Consider industry proposals on acceptable CLIA waiver 
study protocols, develop acceptable protocol designs, and make them 
available by adding appendices to the guidance or by posting redacted 
protocols on the OIVD Web site.
     Track and report our performance on CLIA waiver 
applications and share this information with industry annually and then 
evaluate, at the end of year two, whether user fees and performance 
goals for CLIA waivers should be considered for MDUFMA III;
     Review a list of class I and II low risk IVD devices, 
provided by industry, to determine whether any of them could be 
exempted from premarket notification and allow interested parties to 
petition for exemptions consistent with 510(m)(2);
     Conduct a review of the pre-IDE program to address issues 
raised by industry.
6. Meetings
    FDA would make every effort to schedule informal and formal 
meetings, both before and during the review process, in a timely way, 
and industry would make every effort to provide timely and relevant 
information to make the meetings as productive as possible. These 
meetings include, but are not limited to the following: pre-submission 
meetings, determination meetings, agreement meetings, and 100-day 
meetings.
7. Quarterly Performance Reports
    FDA would report quarterly its progress toward meeting the 
quantitative goals described in this letter. In addition, for all 
submission types, we would track total time (time with FDA plus time 
with the company) from receipt or filing to final decision (approval, 
denial, substantial equivalence (SE), or nonsubstantial equivalence 
(NSE)). We would also provide, on an annual basis, de-identified review 
performance data for the branch with the shortest average review times 
and the branch with the longest average review times for 510(k)s, 180-
day supplements, and real-time supplements.
8. Reviewer Training
    As resources permit, FDA would apply user fee revenues to support 
reviewer training that is related to the process for the review of 
devices, including training to enhance scientific expertise. We would 
provide summary information on the types of training provided to staff 
on an annual basis.

C. Third Party Inspection Program

    FDA is proposing to recommend changes to the third party accredited 
person (AP) inspection program in three major areas. APs are firms 
trained and accredited by FDA to conduct biennial inspections of 
certain medical device firms for compliance with good manufacturing 
practices. The proposals are intended to increase the quantity of 
useful information FDA has about the compliance status of medical 
devices marketed in the United States and to permit FDA to focus its 
inspectional resources on those firms and products posing the greatest 
risk to public health.
    First, FDA is proposing to streamline the administrative burdens 
associated with qualifying for the program. For example, rather than 
having to petition FDA for clearance to use an AP, the proposal would 
require only that firms provide FDA with 30 days prior notice of their 
intent to use an AP listed on FDA's Web site.
    Second, we are proposing to expand participation in the program. 
For example, the current AP program restricts qualified manufacturers 
of class II and class III medical devices to two consecutive AP 
inspections after which FDA must conduct the next inspection, unless 
the manufacturer petitions and receives a waiver from us. We are 
proposing to permit firms to use APs for an unlimited number of 
consecutive inspections without seeking a waiver. However, we would 
continue to conduct ``for cause'' or follow-up inspections whenever we 
deem such inspections appropriate.
    Third, we are proposing to permit device companies to voluntarily 
submit to FDA reports by third parties assessing conformance with an 
appropriate international quality systems standard, such as those set 
by the International Standards Organization. We would consider the 
information in these reports in setting our inspectional priorities.

III. What Information Should You Know About the Meeting?

A. When and Where Will the Meeting Occur? What Format Will We Use?

    Through this notice, we are announcing the convening of a public 
meeting to hear stakeholder views on the recommendations we propose to 
provide to Congress on the reauthorization of MDUFMA II.
    We will conduct the meeting on April 30, 2007. (see ADDRESSES). In 
general, the meeting format will include brief presentations by FDA, 
but will focus on hearing from different stakeholder interest groups 
(such as patient advocates, consumer advocates, industry, health 
professionals, and academic researchers). We will also give individuals 
the opportunity to make presentations at the meeting, and for 
organizations and individuals to submit written comments to the docket 
after the meeting.

B. How Do You Register for the Meeting or Submit Comments?

    If you wish to attend and/or make a presentation at the meeting, 
send an e-mail message to Erik Mettler or Cynthia Garris (see FOR 
FURTHER INFORMATION CONTACT) by April 25, 2007. Your e-mail should 
include the following information: Name, company, company

[[Page 19534]]

address, company phone number, and e-mail address. You will receive a 
confirmation within 2 business days.
    We also will accept walk-in registration at the meeting site, but 
space is limited, and we will close registration when maximum seating 
capacity (approximately 100) is reached.
    We will try to accommodate all persons who wish to make a 
presentation. The time allotted for presentations may depend on the 
number of persons who wish to speak.
    Additionally, regardless of whether you wish to make a presentation 
or simply attend the meeting, please notify us if you need any special 
accommodations (such as wheelchair access or a sign language 
interpreter).
    If you would like to submit comments regarding these proposed 
recommendations, please send your comments to the Division of Dockets 
Management (see ADDRESSES). Submit a single copy of electronic comments 
or two paper copies of any written comments, except that individuals 
may submit one paper copy. Comments are to be identified 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. Submit your comments 
no later than May 18, 2007.

C. Will Meeting Transcripts Be Available?

    We will prepare a meeting transcript and make it available on our 
Web site (http://www.fda.gov) after the meeting. We anticipate that 
transcripts will be available approximately 30 working days after the 
meeting. The transcript will also be available for public examination 
at the Division of Dockets Management (HFA-305), 5630 Fishers Lane, rm. 
1061, Rockville, MD 20857, between 9 a.m. and 4 p.m. Monday through 
Friday.

    Dated: April 12, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-1919 Filed 4-16-07; 1:52 pm]
BILLING CODE 4160-01-S