UL and the UL logo are trademarks of UL LLC © 2012

Regulatory Update

Linda M. Chatwin, Esq, RAC

Business Manager Advisory Services

UL LLC

360-817-5556

Linda.chatwin@ul.com

UL and the UL logo are trademarks of UL LLC © 2012

Agenda

FDA update information

UDI requirements

Benefits of Mock audits

Global Market Access

Areas of Expertise

Global Regulatory Support

•FDA - Pharma, MD, Bio, Cosmetic, Radiation

Standards, reporting, labeling, full range

compliance

•Remediation Services and Mock Audits

•Supplier Audits

•Validation Services

•Regulatory Submissions

•Risk Management

•Human Factors Engineering

•Environmental Support Services

3

UDI Rule

Study Commissioned by FDA

Report Issued March, 2006

• Findings:

• Product identification scenarios – 10 types of tracing activities were

identified

• Varying methods were employed to address device problems

Unable to locate patients

Unable to track patients with implants

No centralized method to learn of issues

• FDA received 66,000 AEs in 2007; 60% with no meaningful identifier

• Benefits of traceability examined – taking data from pharma industry

9

Overview - Continued

• Congress passed the Food and Drug Administration Amendments

Act of 2007 (FDAAA).

• FDAAA mandated FDA to create a unique device identification

system

Track across lifecycle

Really about post market reporting, recalls, etc.

• Final rule published Sept. 24, 2013

10

UDI Rule Published Sept, 2013

Purpose:

• Traceability of devices more efficiently

• Enhances capture of correct information about devices and

reduce medical errors

• Enhances effective adverse event reporting

• Allow easier recall of devices

• Fights against counterfeiting

• Lead to a global device identification system

• Really its about post market reporting, recalls, tracking

Who Needs to Follow the Rule?

• All medical devices for sale in the U.S. must follow the UDI Rule

Note that there are some exceptions for Class I devices

• The person who is responsible for placing a medical device on the market in the U.S. is considered to be the labeler.

• The labeler is responsible to ensure that UDI rule is implemented for all medical devices in the U.S.

• Importers of Medical Devices into the U.S.

Final Rule -Compliance Dates for the UDI

Compliance Date Requirement

1 year after publication of the final

rule (September 24, 2014)

Class III device– Labels and packages bear UDI

Class III stand-alone software must provide its UDI

2 years after publication of the

final rule (September 24, 2015)

Class III life-supporting/life sustaining (LS/LS) devices must

bear permanent UDI

The labels and packages of Class II, I and unclassified

implantable (I) and LS/LS must bear UDI

LS/LS used more than once and reprocessed before each use

must bear permanent UDI

3 years after publication of the

final rule (September 24, 2016)

Class II device– Labels and packages bear UDI

Class III other than LS/LS must bear permanent UDI

Class II stand-alone software must provide its UDI

5 years after publication of the

final rule (September 24, 2018)

Class I or unclassified devices (other than I/LS/LS) Labels and

packages bear UDI

Class II intended for reuse and reprocessed before each use

must bear permanent UDI

Class I stand-alone software must provide its UDI

7 years after publication of the

final rule (September 24, 2020)

All Class I or unclassified devices other than I/LS/LS, that are

intended to be used more than once and reprocessed before

each use must a bear permanent UDI

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UDI Project Management

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Steps in

recommended

sequence

Activities involved

Product

Assessment

1. Identify and prioritize products requiring UDI

2. Recognize and collect information needed for each

product

3. Develop a project plan

Labeling and

Process

Assessment

1. Review label artwork against the UDI requirements

2. Characterize the device identifier(s), product

identifier(s), packaging level(s), etc.

3. Assess current processes against needs to

implement – Procedures to create or modify

GUDID

Submission

1.Determine GUDID interface and submission.

2.Enter UDI data into the Global Unique Device

Identification Database (GUDID)

Auditing, Remediation

FDA Inspection Types

16

FDA Audit Objectives

17

Continued

18

Shared Information

19

Single Audit Program

• Allow the conduct of a single regulatory audit to satisfy

the requirements of multiple regulatory jurisdictions.

• Auditing Organizations authorized by the participating

Regulatory Authorities to audit under MDSAP.

• Australia, Brazil, Canada and the United States.

• “…jointly leverage regulatory resources to manage an

efficient, effective, and sustainable single audit program

focused on the oversight of medical device

manufacturers.”

• MDSAP Pilot is planned to run from January 2014 until

Dec. 2016.

http://www.fda.gov/downloads/medicaldevices/internationalprograms/m

dsappilot/ucm430563.pdf

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Market Access

Regulatory Strategy – A Living Document

RULE NO. 1

RULE NO. 2 – IDENTIFY AREAS

Competitive intelligence

Target markets

Global marketplaces

Company priorities and strategies

• Regulations change!

• Expect it, research, support change

• Regulatory environments

• Agency policy and priority

22

Points to Consider

• Timing of regulatory strategies

• Development stages of product – Indications -

Submissions

• Marketing plan

- U.S.

- EU

- Japan

- China

- BRICS

- Others

23

Manage the Strategy

• Know all your customers

• Internal

- Management

- R&D

- Etc…

• Users

• Distributors

• Regulatory agencies

24

Global Market Access Needs

Technical documentation

Project management

Deep knowledge on regulatory requirements by country

Regulatory updates

Local representatives for marketplace approvals

License holding

Insurance reimbursement

25

Product Life Cycle – Worldwide Regulatory

THANK YOU!

Linda Chatwin, Esq., RAC

Manager – Medical Regulatory Advisory Services

North America

360-817-5556

Linda.Chatwin@ul.com