Regulatory Pathways, Trends, and News from FDA

Mary Beth Henderson, Ph.D., MBA

VP Regulatory Affairs and Quality Systems

Senior Principal Advisor

May 30 and June 01, 2017

©2017 Regulatory and Clinical Research Institute, Inc.

Agenda

Background• FDA Organization

Regulatory Pathways• Device Pathways

• Strategies to consider

Regulatory Trends and News• Greater use of De Novo Approach

• New Initiative to get products to market more quickly

• Focus on Human Factor Testing (Usability)

• Focus on Cybersecurity

Summary

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Background

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FDA Organization

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FDA Numbers: FY 2016

Pre-Submissions: 2,313

Average days to meeting: 67 (53 – 203)

Original IDE applications: 248

129 approved on first cycle

Original PMA/Panel Track Supplements: 72

180 Day Supplements: 208

Real Time Supplements: 326

510(k)s: 3,633 received/3,080 Accepted

Average calendar days to clearance: 154

De Novos: 54

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Regulatory Pathways

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Class I

Exempt

510(k) required

Class II

Exempt

510(k)

De Novo Classification

Class III

Humanitarian Use Exemption

Combination Product

Expedited Access Pathway Program

Device Classification

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•Pre-Submission

•513(g)

• Investigational Device Exemption

Other Submissions

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•Start with your indication for use• What must you have

• What is nice to have

• Identify appropriate product code(s)

• Identify predicate(s) (if available)

• Identify if there are any Special Control Documents

•Develop submission contents

Strategies

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Trends and News

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Greater use of De Novo Approach

MDUFMA 2014

Originally used almost exclusively for IVD

submissions

Went from approximately 50 de novo device

approval (total) to 50 per year

Subject of 4 recent FDA guidance documents

• Factors to consider when making benefit-risk

determinations in premarket approvals and de novo

classifications

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New Initiative

Expedited Access Program

1. Request for designation as an EAP Device (“EAP

Designation”),

2. Agreement on a Data Development Plan,

3. Review of a PMA or de novo request for an EAP

Device, and

4. If approved and appropriate, postmarket data

collection and evaluation.

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New Initiative

EAP Criteria (all of which must be met)

1. The device is intended to treat or diagnose a life-

threatening or irreversibly debilitating disease or

condition. Consider:

• Whether the device is “intended” to treat or diagnose

a life-threatening or irreversibly debilitating disease

or condition

• Whether a disease or condition is “life-threatening

• Whether a disease or condition is “irreversibly

debilitating

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New Initiatives

EAP Criteria

2. The device meets at least one of the following criteria

for addressing an unmet need:

• No appropriate alternative treatment or means of

diagnosis exists.

• The device represents a breakthrough technology that

provides a clinically meaningful advantage over existing

legally marketed technology.

• The device offers significant, clinically meaningful

advantages over existing legally marketed alternatives.

• The availability of the device is in the best interest of

patients (e.g., addresses an unmet medical need).

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New Initiatives

EAP Criteria

3. The sponsor submits an acceptable draft Data

Development Plan

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Focus: Human Factors

Original guidance issued in 1997

Four Guidance Documents issued March 2016:• Comparative Analyses and Related Comparative Use Human

Factors Studies for a Drug-Device combination Product

Submitted in an ANDA

• Applying Human Factors and Usability Engineering to Medical

devices

• Human Factors Studies and Related Clinical Study

Considerations in Combination Product Design and

Development

• List of Highest Priority Devices for Human Factors Review

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Focus: Human Factors Testing

• Help to ensure device safety and effectiveness

• Reduce risk by reducing design flaws/use errors

prior to design lock

• Key component of best practice in design control

• Consider

Device users

Device use environment

Device/User Interface

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Focus: Cybersecurity

Dec 2016

• Postmarket Management of Cybersecurity in Medical

Devices

Oct 2014

• Content of Premarket Submissions for Management of

Cybersecurity in Medical Devices

Feb 2005

• Information for Healthcare Organization about FDA’s

Guidance for Industry: Cybersecurity for Networked Medical

Devices Containing OTS Software

Jan 2005

• Guidance for Industry—Cybersecurity for Networked Medical

Devices Contains OTC Software

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Focus: Cybersecurity

Implement a proactive, comprehensive risk management

program

• Apply the National Institute of Standards and Technology

(NIST) Framework to Strengthen Critical Infrastructure

Cybersecurity

• Establish and communicate processes for vulnerability intake

and handling

• Adopt a coordinated disclosure policy and practice

• Deploy mitigations that address cybersecurity risk early and

prior to exploitation

• Engage in collaborative information sharing for cyber

vulnerabilities and threats

FDA Webinar 17 Jan 21017

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Summary

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Summary

• Regulatory pathway is determined by your

intended use (claims)

• Your regulatory pathway needs to integrate with

your evidence development and reimbursement

strategy

• Pre-submissions are an excellent method of

obtaining FDA feedback (i.e., prior to

animal/human clinical testing)

• Any device with software is being reviewed more

rigorously

Mary Beth Henderson, Ph.D., MBA

Vice President Regulatory Affairs & Quality Systems, Sr. Principal Advisor

Regulatory and Clinical Research Institute, Inc. (RCRI)

5353 Wayzata Blvd. Suite 505, Minneapolis, MN 55416

Direct: 952-595-5580 Cell: 612-8399138

mbhenderson@rcri-inc.com www.rcri-inc.com

Questions