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 [email protected]
Welcome message from author
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
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
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
Pr
oj
ec
t M
an
ag
em
en
t
UDI Project Management
14
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
20
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
Related Documents
