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FDA Updates
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Regulatory Discussion
SARTA Meeting
Presenter
October XX, 2010
August 22, 2012
AGENDA
• Review recent FDA changes relevant to
medical devices
• Upcoming FDA changes
• Discussion and Questions
CDRH Plan of Action for 510(k) and
Science
3
Background
August 2010 Reports
» 510(k) Working Group
» To evaluate the 510(k) program and explore actions CDRH could
take to enhance the agencies 510(k) decision making
» Task Force on the Utilization of Science in Regulatory Decision
Making
» To assess the way CDRH uses science in regulatory decision making
and identify steps the agency could take to strike a better balance
between these two critical aims
Background
CDRH Plan of Action for 510(k) and Science
• 25 specific actions and accompanying timelines for
completion or for reaching a milestone in 2011
• Goal: Make the 510(k) program a blueprint for smarter
medical device oversight; one that drives innovation
and brings important technologies to patients
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Three main areas of emphasis
• Create a culture of change toward greater
transparency, interaction, collaboration, and the
appropriate balancing of benefits and risks;
• Assure predictable and consistent recommendations,
decision making, and application of the least
burdensome principle; and
• Implement efficient processes and use of resources.
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Update on Implementation and
Accomplishments
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Guidance – 510(k) Modifications
Milestone date: June 15, 2011
Draft issued: July 27, 2011 – very similar to 1997 version
• Purpose of the revision:
» To address issues associated with software and other rapidly
changing technologies
» To provide greater clarity about changes that do and do not trigger
the need for a new premarket submission
• Prior Vague areas defined:
» Changes that “could significantly affect” safety and effectiveness
» Changes to intended use considered “major” causing new 510(k)
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FDA Internal & Administrative
Matters
Leverage External Experts
» Completed on October 4, 2011
• Develop a network of external experts to appropriately
and efficiently leverage scientific expertise
• To assess best-practices and develop SOPs for staff
engagement with external experts
• SOP has been posted to FDA website
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalPro
ductsandTobacco/CDRH/CDRHReports/ucm271521.htm
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FDA Internal & Administrative
Matters
Enhance Training
• Reviewer certification launched Sept 6, 2011
»
»
»
»
18-month program
All new reviewers required to go through the program
On-line, instructor-led, practical experience
Medical device, FD&C law, regulatory requirements, CDRH
review process, device design, impact of human factors
• Experiential learning program – next to launch
» Visits to academic institutions, manufacturers, research
organizations, healthcare facilities
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FDA Guidance
De Novo Classification Process
Posted to FDA’s website on September 30, 2011
Draft Guidance for Industry and Food and Drug Administration Staff - De Novo
Classification Process (Evaluation of Automatic Class III Designation)
•
Provides route to market for medical devices that are low to moderate risk, but
have been classified as class III because FDA has found them to be NSE to legally
marketed predicate
•
Provides greater clarity about the suitability of a device for the de novo process,
and timely input on the type of data necessary to support de novo classification
•
When final, this guidance will replace “New Section 513(f)(2) – Evaluation of
Automatic Class III Designation, Guidance for Industry and CDRH Staff,” dated
February 19, 1998.
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FDA Guidance
Feasibility/First in Human
Posted on FDA Website on November 10, 2011
Draft Guidance for Industry and Food and Drug Administration Staff –
Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical
Studies, Including Certain First in Human (FIH) Studies
•
Provides guidance to FDA staff, clinicians, clinical innovators, and industry on
development and review of Investigational Device Exemption (IDE)
applications for early feasibility studies of significant risk devices.
•
Developed to facilitate early clinical evaluation of medical devices in the U.S.
under IDE regulations using risk mitigation strategies that appropriately
protect human subjects in early feasibility studies.
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FDA Guidance
IDE Decisions
Posted on FDA’s Website on November 10, 2011
Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and
Food and Drug Administration Staff - FDA Decisions for Investigational Device
Exemption (IDE) Clinical Investigations
•
Provides clarification regarding the regulatory implications of the decisions that
FDA may render based on review of an IDE and to provide a general explanation of
the reasons for those decisions
•
Methods to allow a clinical investigation of a device to begin under certain
circumstances, even when there are outstanding issues regarding the IDE
submission. These mechanisms, include:
»
approval with conditions,
»
staged approval,
»
communication of outstanding issues related to the IDE through future considerations
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FDA Guidance
510(k) Program
Posted to FDA’s website on December 27, 2011
Draft Guidance for Industry and Food and Drug Administration Staff - The 510(k) Program:
Evaluating Substantial Equivalence in Premarket Notifications [510(k)]
•
Provide greater clarity regarding the following;
»
when clinical data should be submitted in support of a 510(k);
»
submission of photographs or schematics for internal FDA use only;
»
appropriate use of multiple predicates;
»
criteria for identifying "different questions of safety and effectiveness" and technological
changes that generally raise such questions;
»
Resolving discrepancies between the 510(k) flowchart and the Food, Drug, and Cosmetic
Act;
»
characteristics that should be included in the concept of “intended use”; and
»
development of 510(k) summaries to assure they are accurate and include all required
information.
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FDA Guidance
Appeals Guidance
Posted to FDA’s website on December 27, 2011
Draft Guidance for Industry and Food and Drug Administration Staff CDRH Appeals Processes
• Individuals outside of FDA who disagree with a decision or action taken by
CDRH and wish to have it reviewed or reconsidered have several processes
for resolution from which to choose including requests for supervisory
review of an action, petitions; and hearings.
• Provides general information about each process and guidance on how to
submit requests
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FDA Guidance
Product Code
Posted to FDA’s website on December 30, 2011
Draft Guidance for Industry and Food and Drug Administration Staff Medical Device Classification Product Codes
• Educates regulated industry and FDA Staff on classification product
codes for medical devices regulated by CDRH and CBER.
• Describes how classification product codes are used in a variety of
FDA program areas to regulate and track medical devices.
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FDA Guidance
Benefit-Risk
Posted on Final Guidance on FDA’s Website on March 28, 2012
Guidance for Industry and Food and Drug Administration Staff: Factors to Consider
When Making Benefit-Risk Determinations in Medical Device Premarket Approval
and De Novo Classifications
•
Explains principal factors FDA considers when making benefit-risk
determinations in the premarket review of devices subject to PMA or de
novo classification petitions.
•
Benefit-risk factors should be considered during the design, non-clinical
testing, pre-IDE, and IDE phases as well as in assembling and assessing
PMA application or de novo petitions.
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FDA Guidance
Pre-Submission Interactions (Pre-IDE)
Posted to FDA’s website on July 13, 2012
Draft Guidance for Industry and FDA Staff Medical Devices: The Pre-Submission
Program and Meetings with FDA Staff
• Outlines clear recommendations for sponsors and for FDA staff and
managers as well as expected timeframes for scheduling meetings
• Describes procedures CDRH and CBER intend to follow when
manufacturers, their representatives, or application sponsors request a
meeting with review staff, either as the preferred method of feedback in
response to a Pre-Submission, or to discuss to an existing regulatory
submission, and recommends how to prepare for meetings with FDA staff.
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FDA Guidance
Refuse to Accept Policy for 510(k)s
Posted to FDA’s website on August 13, 2012
Draft Guidance for Industry and Food and Drug Administration Staff – Refuse to
Accept Policy for 510(k)s
• Updates the CDRH 510(k) Refuse to Accept Policy issued on June 30, 1993
and 510(k) Refuse to Accept Procedures, 510(k) Memorandum K94-1
• Policy modified to include an early review against specific acceptance
criteria and to inform the submitter within the first 15 calendar days
after receipt if the submission is administratively complete, or if not, to
identify the missing elements.
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FDA Guidance
Refuse to Accept Policy for 510(k) (cont.)
• FDA staff will answer the preliminary questions
»
Based on the answers to the these preliminary questions, the remainder of the acceptance
review may or may not be necessary.
»
If responses to the questions and consultation with the Center personnel indicate that the
510(k) acceptance review should not continue and reviewer should promptly notify the
submitter
• Appendices include Acceptance Checklist for traditional, special or
abbreviated 510(k)s
»
Clarifies the necessary elements and contents of a complete 510(k) submission
• Process applicable to all devices reviewed through the 510(k) notification
process
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FDA Guidance
Refuse to Accept Policy for 510(k) (cont.)
• FDA encourages all submitters to review the checklists to
incorporate the requirements and also encourages submitters to
provide an electronic copy in place of one of the two hard copies
of the 510(k) submissions
• Comments and suggestions regarding this draft document may be
submitted within 45 days.
» 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.regulations.gov.
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CDRH Transparency
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CDRH Transparency
• FDA formed the Transparency Task Force to develop
recommendations for making useful and understandable
information about FDA activities and decision making more readily
available to the public in a timely manner and in a user-friendly
format.
• In support of the Agency’s Transparency Initiative, CDRH launched
a Transparency Web site to provide meaningful and timely
information about the products it regulates and the decisions it
makes.
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalPro
ductsandTobacco/CDRH/CDRHTransparency/ucm199624.htm
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CDRH Transparency – What’s New
•
Addition of Evaluation of Automatic Class III Designation Decision (de novo)
Summaries to FDA website
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacc
o/CDRH/CDRHTransparency/ucm232269.htm
•
Addition of PMA Summary Review Memos for 180-Day Design Changes
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pmamemos.cfm
•
Total Product Life Cycle (TPLC)
Databasehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTPLC/tplc.cfm
•
The PMA Clinical Trials Database is abstracted from Premarket Approval (PMA)
Summaries of Safety and Effectiveness data
(SSED).http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsand
Tobacco/CDRH/CDRHTransparency/ucm204243.htm
•
Investigational Device Exemption (IDE) - Pivotal IDE Description Summary
Formhttp://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTo
bacco/CDRH/CDRHTransparency/ucm205697.htm
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FDA Guidance Documents
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FDA Guidance
Acceptance and Filing Review for PMAs
Draft issued July 31, 2012
Draft Guidance: Acceptance and Filing Review for Premarket Approval Applications
(PMAs)
• Threshold determination whether application is administratively complete
prior to substantive review
• Appendices provide checklists for acceptance and filing of PMAs
• Acceptance review is 15 calendar days (same as new 510(k) RTA Policy)
• Administrative processes of filing review phase is 45 days:
» Document tracking
» Distribution and handling
» Assembling the review team
» Setting up the filing meeting
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Planned Guidance Documents
• Standards Guidance
» To clarify the appropriate use of consensus standards due
October 31, 2011
• Interactive Review and other Communications
• Other MDUFA-Related Guidance Documents
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Planned OIVD Guidance Documents
• Class II Special Controls Guidance Document: Tryptase Test
System
• Class II Special Controls Guidance Document: Dengue Virus
Serological Reagents
• Establishing the Performance Characteristics of In Vitro
Diagnostic Devices for the Detection of methicillin-resistant
Staphylococcus aureus (MRSA) for Culture Based Devices
(Final)
• Finalization of any drafts that were published in the last
couple of years
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MDUFA III
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MDUFA III
• Medical Device User Fee Amendments 2012 (MDUFA III)
» Take effect on October 1, 2012 and will sunset in five years on
October 1, 2017
» Represents a commitment between the US Medical device
industry and the FDA to increase efficiency of regulatory
processes in order to reduce the time it takes to bring safe and
effective medical devices to the U.S. Market
» The FDA is authorized to collect user fees that will enable FDA
to hire more than 200 full-time-equivalent workers
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MDUFA III
»
Process improvements that will help achieve MDUFA III
» Improved Pre-Submission Process
The FDA will introduce a more structured approach to address product-specific
questions regarding review issues for PMAs, 510(k)s and Investigational Device
Exemptions (IDEs)
» Submission Acceptance Criteria
The FDA will implement revised submission acceptance criteria through
guidance.
» Interactive review
The Agency will continue to incorporate an interactive review process to
provide for, and encourage, informal communication between FDA and
applicants to facilitate timely completion of the review process based on
accurate and complete information.
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MDUFA III
»
Process improvements that will help achieve MDUFA III (cont.)
» Guidance Document Development
FDA will apply user fee revenues to supplement the improvement of the
process of developing, reviewing, tracking, issuing, and updating guidance
documents.
FDA will update its website in a timely manner to reflect the following:
1. The Agency’s review of previously published device guidance documents,
including the deletion of guidance documents that no longer represent the
Agency’s interpretation of, or policy on, a regulatory issue, and notation
of guidance documents that are under review by the Agency;
2. A list of prioritized device guidance documents (an “A-list”) that the
Agency intends to publish within 12 months of the date this list is
published each fiscal year; and
3. A list of device guidance documents (a “B-list”) that the Agency intends to
publish, as the Agency’s guidance-development resources permit each
fiscal year.
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MDUFA III
»
Guidance Document Development (cont.)
The Agency will establish a process allowing stakeholders an
opportunity to:
1. Provide meaningful comments and/or propose draft language for proposed
guidance topics in the “A” and “B” lists.
2. Provide suggestions for new or different guidance documents; and
3. Comment on the relative priority of topics for guidance.
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MDUFA III
» Process improvements that will help achieve MDUFA III (cont.)
» Third-Party Review
MDUFA III authorizes the third-party review program.
» Patient Safety and Risk Tolerance
FDA will fully implement final guidance on the factors to consider
when making benefit-risk determinations in medical device
premarket review.
» Low Risk Medical Device Exemptions
By the end of FY 2013, FDA will propose additional low risk medical
devices to exempt from premarket notification. Within two years
of such proposal, FDA intends to issue a final rule exempting
additional low risk medical devices from premarket notification.
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MDUFA III
»
Process improvements that will help achieve MDUFA III (cont.)
»
Emerging Diagnostics
FDA will work with industry to develop a transitional In Vitro Diagnostics
(IVD) approach for the regulation of emerging diagnostics.
»
Performance goals – Staffing & Training and Tracking
User fees will provide the FDA with additional resources to recruit, train, and
retain employees with the expertise needed to meet these goals, and
additional resources to update the agency’s information technology systems
to facilitate meeting those performance goals.
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Reorganization
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Reorganization
• Proposed OIVD Reorganization beginning FY2013
» Office of In Vitro Diagnostics and Radiological Health (OIR)
» Division of Chemistry and Toxicology (DCTD), Division of
Immunology and Hematology (DIHD), Division of Microbiology
(DMD), Division of Program Operations and Management (DPOM),
Division of Radiological Health (DRH) and Division of Mammography
Quality Standards (DMQS)
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Reorganization
• Adding branches
» Consistent with the rest of the Center
• Adding Post-market Radiology
• Adding all Radiological Health
• Adding Mammography Quality Standards Act and
Program
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Reorganization
Division of Chemistry and
Toxicology (DCTD)
• Chemistry
• Diabetes
• Toxicology
• Cardio-Renal
Division of Immunology and
Hematology (DIHD)
• Hematology
• Immunology and Flow
Cytometry
• Molecular Pathology and
Cytology
• Immunology/Hematological
Genetic Distorders
Division of Microbiology (DMD)
• Viral Respiratory and HPV
• General Viral and Hepatitis
• General Bacterial and
Antimicrobial Susceptibility
• Bacterial Respiratory and
Medical Countermeasures
Division of Program Operations
and Management (DPOM)
• Program Operations
• Management Operations
Division of Radiological Health
(DRH)
• Magnetic Resonance and
Electronic Products
• Diagnostic X-Ray Systems
• Nuclear Medicine and Radiation
Therpay
• Mammography, Ultrasound and
Software
Division of Mammography Quality
Standards
• Program Management
• Information Management
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Discussion and Questions
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Accomplishments
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Accomplishments
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Accomplishments
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Accomplishments
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Accomplishments
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Accomplishments
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