Medical Device Provisions of the FDA Amendments Act of 2007

Presentation Outline

Title II Medical Device User Fee Amendments

MDUFMA II Performance Goals

Title III Pediatric Medical Device Safety and Improvement Act

Title VIII Clinical Trial Databases

Title VI Reagan-Udall Foundation

Title VII Conflicts of Interest

Title XI Other Provisions

Title II MDUFMA IITitle II MDUFMA II

New Definitions

30-Day Notice 513(g) Requests Annual Periodic Reports Establishment Subject to Annual Registration

Fees

Authority To Assess and Use Device Authority To Assess and Use Device FeesFees

Fees Structure   

2007 Fees & Relationships Base Year Fee Amounts for 2009-2012

2007 Fee 2008 Fee 2009 Fee 2010 Fee 2011 Fee 2012 Fee

Full PMA/BLA Fee $ 281,600 $ 185,000 $ 200,725 $ 217,787 $ 236,298 $ 256,384

Small Businesses Making Above Submissions $ 107,008 $ 46,250 $ 50,181 $ 54,447 $ 59,075 $ 64,096

Full Fee for Panel Track Supplements $ 281,600 $ 138,750 $ 150,544 $ 163,340 $ 177,224 $ 192,288

Small Businesses Making Above Submissions $ 107,008 $ 34,688 $ 37,636 $ 40,835 $ 44,306 $ 48,072

180-Day Supplements Full Fee $ 60,544 $ 27,750 $ 30,109 $ 32,668 $ 35,445 $ 38,458

Small Businesses Paying Above Fee $ 23,007 $ 6,938 $ 7,527 $ 8,167 $ 8,861 $ 9,614

Real Time Supplements Full Fee $ 20,275 $ 12,950 $ 14,051 $ 15,245 $ 16,541 $ 17,947

Small Businesses Paying Above Fee $ 7,705 $ 3,237 $ 3,512 $ 3,810 $ 4,134 $ 4,485

510k Fee $ 4,158 $ 3,404 $ 3,693 $ 4,007 $ 4,348 $ 4,717

Small Businesses Paying Above Fee $ 3,326 $ 1,702 $ 1,847 $ 2,004 $ 2,174 $ 2,359

30-Day Notice Fee

       

$ 2,960 $ 3,212 $ 3,485 $ 3,781 $ 4,102

Small Businesses Paying Above Fee $ 1,480 $ 1,606 $ 1,742 $ 1,890 $ 2,051

513(g) fee $ 2,498 $ 2,710 $ 2,940 $ 3,190 $ 3,461

Small Businesses Paying Above Fee $ 1,249 $ 1,355 $ 1,470 $ 1,595 $ 1,731

Device Registration Fee $ 1,706 $ 1,851 $ 2,008 $ 2,179 $ 2,364

Annual Report Filing Fee $ 6,475 $ 7,025 $ 7,623 $ 8,270 $ 8,973

Small Businesses Making Above Submissions $ 1,619 $ 1,756 $ 1,906 $ 2,068 $ 2,243

Authority To Assess and Use Device Authority To Assess and Use Device FeesFees

Payment Refunds for modular PMAs Annual establishment registration fee

Annual Fee SettingAnnual Fee Setting

Small Businesses Fee Reductions

Foreign Small Business qualification Reduced fees for Small Businesses

Conditions of Trigger

Maintains same trigger from MDUFMA I Device appropriations adjusted for inflation

Annual Fee SettingAnnual Fee Setting

Crediting and Availability of Fees

$48 Million for FY 2008

$52 Million for FY 2009

$57 Million for FY 2010

$61 Million for FY 2011

$67 Million for FY 2012

Offset Delayed Until FY 2012 fees

Annual Fee SettingAnnual Fee Setting

Annual Reports

Performance Report Financial Report

Reauthorization Procedures

Public input prior to negotiations Monthly updates to patient and consumer groups Public review of final recommendations Minutes of negotiation meetings on FDA Website

Annual Fee SettingAnnual Fee Setting

Additional Authorization for Postmarket Safety $7.1 Million in FY2008 Adjusted each FY by 5%

Effective Date October 1, 2007

Sunset Clause October 1, 2012

Extension of Third Party Review Program

Sunsets October 1, 2012

Registration

Changes registration to the first quarter of Fiscal Year (Oct. 1 to Dec.31)

Requires foreign establishments to register

Filing of List of Devices

Requires Listing of devices in the first quarter of Fiscal Year

Electronic Registration and Listing

Requires Registration and Listing to be done electronically

GAO Report on 510(k) Process

Study on appropriate use of 510(k) process

“Safe and effective as a classified device”

Evaluation of intended uses and technologies

Report due October 1, 2008

Unique Device Identification System

Regulations requiring label of device to bear a Unique Identifier

Alternative placement or exemption allowed

May include information on lot or serial number

Identify device through distribution and use

Frequency of MDR Reporting for Certain Devices

Permits quarterly summary reporting of malfunction MDRs

Devices designated by the Secretary

Cannot be Class III or implantable, life sustaining, life supporting Class II

Third Party Inspection Program

Reduces some procedural barriers

Only facilities with recent NAI inspections eligible

Allows submission of ISO 13485 reports for FDA’s inspectional priorities

GAO Study of Nosocomial Infections

Number due to new and reused Devices

Causes Including:

Reprocessing of Single Use Devices

Handling of sterilized devices

Hospital infection control practices

Health care professionals’ practices

FDA Report on Labeling of Tanning Devices

Labeling requirements adequate

Consumer understanding of label warnings

FDA report due October 1, 2008

MDUFMA II Performance Goals

Quantitative Goals

Goals measured in FDA days

Decision goals-no cycle goals

Goals apply to FY2008 to 2012

Original PMAs, Panel-track PMA Supplements and Premarket Reports

60% in 180 days 90% in 295 days

MDUFMA II Performance Goals

Expedited PMAs, Panel-track PMA Supplementsand Premarket Reports

50% in 180 days 90% in 280 days

PMA Modules

75% in 90 days 90% in 120 days

MDUFMA II Performance Goals

180-day PMA Supplements 85% in 180 days 95% in 210 days

Real-time Supplements 80% in 60 days 90% in 90 days

MDUFMA II Performance Goals

510(k) Submissions

90% in 90 days

98% in 150 days

Qualitative Goals

Interactive Review

FDA will issue guidance 3 months post enactment

Promote informal communications between FDA and sponsor

FDA will use all forms of communication

Sponsor is expected to respond to requests in agreed upon time

If requested information is not received, FDA will stop the review clock

Qualitative Goals

Meetings

FDA will scheduled informal and formal meetings in timely manner

Qualitative Goals

Quarterly Performance Reports

FDA will provide performance updates to industry

FDA will also track total time from receipt to final decision

De-identified review branch performance annually

Qualitative Goals

Reviewer Training

Summary information on types of training provided annually

Qualitative Goals

Guidance Document Development

FDA will post list of guidance documents for development each year

FDA will accept suggestions for new or different guidances

FDA will provide opportunity for comments or draft language

Qualitative Goals

Imaging Devices with Contrast Agents or Radiopharmaceuticals

FDA will develop a guidance document on review of these products

FDA will publish guidance by end of FY 2008

In Vitro Diagnostics

New or Revised Guidance documents on:

Clinical trials involving de-identified leftover specimens

Clinical trial design for molecular diagnostics

Migration studies

Herpes Simplex Virus IVDs

Enterovirus IVDs

Influenza testing

In Vitro Diagnostics

Pilot program on review of CLIA waivers and 510(k)s

CLIA waiver study protocols

Tracking review times for CLIA waiver applications

Reviewing list of Class I and Class II low risk IVDs

Pre-IDE review program for IVD devices

Pediatric Medical Device Safety and Improvement Act

Tracking Pediatric Device Approvals

Pediatric subpopulations described in HDE and PMA applications

Number of pediatric patients affected

Annual Report to Congress

Determination of Pediatric Effectiveness

Use of adult data to support approval for pediatric population

Extrapolation of data from one pediatric subpopulation to another

Modifications to Humanitarian Device Exemptions

Profit prohibition eliminated for Pediatric HDEs Annual distribution cannot exceed distribution in

the first year Adverse Events reported to Office of Pediatric

Therapeutics FDA required to issue guidance to IRBs in 180

days GAO Report assessing impact of HDE profit

exemption

Encouraging Pediatric and Medical Device Research & Development

HHS plan for pediatric device R & D

Plan due in 180 days Status of federally funded Research Identification of any gaps Research agenda for improving development

of pediatric devices

Demonstration Grants for Improving Pediatric Device Availability

HHS to issue RFPs for demonstration projects in 90 days

Description of how federal funds are to be used

Office of Pediatric Therapeutics

Pediatric access to devices added to the role of the Office

Pediatric Advisory Committee to include devices

Title VIII Clinical Trials Databases

General Requirements

Mandatory registration of applicable device trials in www.Clinicaltrials.gov

Small feasibility trials excluded from definition of applicable trial

Potential retroactivity to trials completed before enactment

Certification of compliance submitted with PMA, HDE, or 510(k)

Registry Submission and Posting

Registration applies to trials initiated after enactment or ongoing 90 days after enactment

Posting of registration delayed 30 days after clearance or approval

Results Submission and Posting

Results data submitted 1 year after earlier of estimated or actual trial completion

FDA will expand required data to be submitted 1 year post enactment

FDA will promulgate regulations 3 yrs post enactment on expansion of data bank

Prohibited Acts and Civil Penalties

Failure to comply or submission of false or misleading information

Establishes strict liability (no intent necessary)

Establishes fines and Civil Money Penalties

Postmarket Surveillance

FDA may order 522 study as condition of clearance or approval

For significant use in a pediatric population

FDA may order longer studies for pediatric devices

Allows dispute resolution for orders to conduct 522 studies

Title VI Reagan Udall Foundation

Foundation

Modernize development of FDA regulated products

Accelerate innovation

Enhance product safety

Establishes Foundation Board of Directors

Office of Chief Scientist

Established within Office of Commissioner

Responsible for oversight coordination and QA of intramural research at FDA

Critical Path Public-Private Partnerships

Collaborative Agreements with eligible entities Institutions of Higher Education 501(c)(3) Non Profit Organizations

Funding from regulated industry not permitted

Title VII Conflicts of Interest

Advisory Committee member recruitment

Disclosure of financial interest required

Waivers permitted

Reductions in number of waivers over next 5 years

Title XI  Other Provisions

Improving Genetic Test Safety and Quality

Requires IOM to conduct study to assess quality and safety of genetic tests

IF

Secretary’s Advisory Committee on Genetics, Health and Society does not issue report by July 2008