medical device provisions of the fda amendments act of 2007
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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 - PowerPoint PPT PresentationTRANSCRIPT
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