regulatory pathways, trends, and news from fda€¦ · •new initiative to get products to market...

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

©2017 Regulatory and Clinical Research Institute, Inc.

Background

©2017 Regulatory and Clinical Research Institute, Inc.

FDA Organization

©2017 Regulatory and Clinical Research Institute, Inc.

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

©2017 Regulatory and Clinical Research Institute, Inc.

Regulatory Pathways

©2017 Regulatory and Clinical Research Institute, Inc.

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

©2017 Regulatory and Clinical Research Institute, Inc.

•Pre-Submission

•513(g)

• Investigational Device Exemption

Other Submissions

©2017 Regulatory and Clinical Research Institute, Inc.

•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

©2017 Regulatory and Clinical Research Institute, Inc.

Trends and News

©2017 Regulatory and Clinical Research Institute, Inc.

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

©2017 Regulatory and Clinical Research Institute, Inc.

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.

©2017 Regulatory and Clinical Research Institute, Inc.

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

©2017 Regulatory and Clinical Research Institute, Inc.

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).

©2017 Regulatory and Clinical Research Institute, Inc.

New Initiatives

EAP Criteria

3. The sponsor submits an acceptable draft Data

Development Plan

©2017 Regulatory and Clinical Research Institute, Inc.

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

©2017 Regulatory and Clinical Research Institute, Inc.

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

©2017 Regulatory and Clinical Research Institute, Inc.

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

©2017 Regulatory and Clinical Research Institute, Inc.

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

©2017 Regulatory and Clinical Research Institute, Inc.

Summary

©2017 Regulatory and Clinical Research Institute, Inc.

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