EXPERTS

A PARTNER

IN DRUG AND DEVICE DEVELOPMENT

US Medical Device Regulations and

Regulatory Landscape

PRESENTED BY:Michael Winegar

Vice President, Regulatory AffairsMedpace Medical Device

Regulatory Agencies

Classification of Medical Devices

KOREAUNITED STATES EUROPE

RISK PROFILE

Class I Class I Class I Very Low Risk

Class II

Class II

Class IIa Low Risk

Class III Class IIb Medium Risk

Class IV Class III Class III High Risk

Comparison of Submission Types

KOREA UNITED STATES

Class IPremarket Notification

Class IGeneral ControlsExempt or 510(k)

Class IIPremarket Approval

Class IIGeneral ControlsSpecial Controls

Exempt or 510(k)Class III

Premarket Approval

Class IVPremarket Approval

Class IIIGeneral Controls

Premarket Approval

Comparison of Submission Requirements

KOREA UNITED STATES

Class IPremarket Notification

Class IExempt (usually)

Class II/III/IVPremarket ApprovalTechnical File Review

4-6 months

Safety/Efficacy Review + Type Testing

6-10 months

Class II510(k) (usually)

Bench, animal, comparative data

3 month review

Class IIIPMA (usually)

+ Human clinical data6 month review

FDA: Current Topics and Trends

• 510k reform• Medical Device

Tax• CMS (Centers

for Medicare and Medicaid Services)

• Audit

510(k) Reform - Background

Criticism - overly complex devices get to the US market without premarket approval (PMA)

» Metal-on-metal hip implants

» Knee implants» Vaginal mesh

Recommendation - all Class III devices be subject to the PMA process

FDA should take steps to ensure that high-risk Device types are approved through the most stringent premarket review process.”

“2009 Government Accountability Office Report

510(k) Assessment at 35 years

Findings:• 510(k) process does not

assess safety or efficacy• 510(k) process use of

“predicate devices” sets binding precedent on FDA

• CDRH found lacking of human, financial, and technical resources

• Based on its legislative foundation, concluded that 510(k) process is flawed, and should be eliminated!

2011 Institute of Medicine Report “Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years”

510(k) Reform - Another Perspective Review of all Class I recalls in 2005

through 2009 (n=118):• 55% of recalls relate to post-market

issues• 99.78% of 510(k) submissions do not

result in a Class I recall due to premarket issues

Conclusion: additional human studies of 510(k) devices will not have a significant

impact on Class I recallsSource: 2010 Ralph Hall, University of Minnesota Law School, presentation entitled “Using Recall Data To Assess The 510(k) Process”

510(k) Reform:Implementation Plan

Consists of 25 proposals to be implemented in 2011

Key proposals include:• Eliminate use of multiple predicate

devices Create a “Class IIb” category • New 510(k) would be required, rather than

modification of an existing 510(k), that might affect safety or efficacy

• More 510(k)’s will require clinical data, and therefore clinical trials

Draft “510(k) Paradigm Guidance” to be issued by FDA

FDAthe

PLAN

Medical Device Tax

Part of 2010 Affordable Care Act

2.3% levy on medical device companies

Set to go into effect in 2013 Intended to raise $20 billion

US over 10 years

DEVICEthe

TAX

Medical Device Tax

Reaction/Predictions• US medical devices manufacturers will create/expand

overseas facilities (The Advanced Medical Technology Association (AdvaMed) )

• Costs will be passed on to patients, and therefore, in many cases, back to the government health system (The Centers for Medicare and Medicaid Services (CMS))

Status• IRS currently writing rules to implement tax• AdvaMed, others, pushing for full/partial repeal

FDA Review Trends: 510(k) Decisions

Source: FDA

FDA Review Trends: 510(k) AI Requests

Source: FDA

FDA Review Trends: PMA Decisions

Source: FDA

FDA Review Trends

Fiscal 2000

Fiscal 2009

Source: FDA’s Office of Device Evaluations

IDE approvals upon initial review

FDA-CMS Parallel Review Program

Pilot program for concurrent review of certain FDA premarket review submissions for medical devices and CMS national coverage determinations • Goal: reduce the interval between FDA approval and CMS

coverage to bring new technologies to patients quicker

During this pilot phase, up to five “new technology” devices/year will be eligible. Must meet one of these criteria:• Approved IDE• Would/will require a PMA• Fall within the scope of a current Medicare benefit category

FDA Audits of CROs FDA Compliance Program 7348.810

• BIORESEARCH MONITORING (BIMO) program» An FDA audit of Sponsor and select clinical

study sites, to ensure compliance with relevant regulations

• Revised March 2011 to include CROs and Monitors» FDA medical device regulations

(21 CFR Part 812) do not define or delineate responsibilities for CROs

• FDA can, and has begun to, audit CROsindependent of a specific IDE/PMA activity» Findings of CRO audit may lead FDA to

conduct Sponsor and/or clinical study site BIMO audits

Regulatory Reform Initiative

Executive Order 13563, issued on Jan. 18, 2011:

• Ensure that the benefits justify the costs and to select the least-burdensome alternatives

• Increased public participation and an open exchange

• Harmonize, simplify, and coordinate rules

• Consider flexible approaches that reduce burdens and maintain freedom of choice for the public 

Regulatory Reform Initiative

HHS issued a Preliminary Plan on May 18, 2011 Review of existing

regulations to help ensure that FDA’s regulatory program is more effective and less burdensome in achieving its regulatory objectives

Medical Device Innovation Initiative

FDA 2010 and 2011 Strategic Plan Facilitate the development

and regulatory evaluation of innovative medical devices: • Establish the Innovation Pathway

- a priority review program for pioneering medical devices

• Streamline the de novo pathway

Medical Device Innovation Initiative

Strengthen the U.S. research infrastructure and promote high-quality regulatory science: • Voluntary third-party certification program for test

centers• Public core curriculum for medical device

development and assessment• Leverage device experience and data collected

outside the US• Prioritize scientific research, establish public-

private partnerships, collaborate with other government agencies, and hold public workshops

Medical Device Innovation Initiative Prepare for and respond to

transformative innovative technologies and scientific breakthroughs: • Enhance CDRH's current horizon scanning

process» Adopt emerging horizon scanning methods» Seek public input to identify important and

innovative medical device technologies» Periodically report horizon scanning findings to the

public

• Develop Networks of Experts to assist in addressing scientific questions about unfamiliar emerging technologies

Conclusions

More similarities than differences in regulationsPositive impact for global clinical trials and

submissions

Regulations are under increased scrutinyPublic, congressional, industry pressures

The cost of healthcare remains an issueBalancing the need for and requirements of innovation

Indications of positive change on the horizonSignals of changes to come from FDA

Thank You!감사합니다

Michael WinegarVice President, Regulatory Affairs

Medpace Medical Device3787 95th Ave. NE Suite 100

Blaine, MN 55014 USATel: +1.612.234.8491

E-mail:  m.winegar@medpace.com