On April 30, 2013, Dr. David Lim, President and Principal of REGULATORY DOCTOR (http://www.RegulatoryDoctor.com) shared his comments during FDA workshop entitled "Accessible Medical Device Labeling in a Standard Content and Format." This is Dr. David Lim's presentation slides.

1. Copyright © 2011-2013 Regulatory Doctor. All Rights Reserved. 1
Comments on a Standard
Content and Format
(FDA Workshop on Accessible Medical Device Labeling)
April 30, 2013
REGULATORY DOCTOR
www.REGULATORYDOCTOR.com
Dr. David Lim, Ph.D., RAC, ASQ-CQA
President and Principal

2. Copyright © 2011-2013 Regulatory Doctor. All Rights Reserved. 2
REGULATORY DOCTOR
 We provide “Practical, Actionable, and Sustainable
Solutions in an Integrated, Thorough (“PASS-IT”)
Manner to the Global Healthcare Industry.
 We have a special interest in “Accessible Medical
Device Labeling in a Standard Content and Format.”

3. Copyright © 2011-2013 Regulatory Doctor. All Rights Reserved. 3
Accessible Medical Device Labeling in
a Standard Content and Format
• Thank You for This Great Initiative/Public
Workshop
• Our Experience
• NEEDED!!!

4. Copyright © 2011-2013 Regulatory Doctor. All Rights Reserved. 4
Contents
• Intended Use/Indications for Use
– Specific Populations
– Proper Usage/Operations
• General Information
– Contraindications
– Warnings/Precautions
– Adverse Reactions/Events/Interactions

5. Copyright © 2011-2013 Regulatory Doctor. All Rights Reserved. 5
Contents – Cont.
• Device 510(k) Number/PMA Number
– To prevent/reduce misbranding
• Pictorial Presentation of Device(s) (e.g., Images/Photos)
• Label Information (UDI)
• FDA-Generated Symbols/Signs/Cartoons for High Risk Devices
• Summary Information of Safety and Effectiveness
• Summary of Tests Done
– Bench Testing(s)
– Animal Testing(s)
– Clinical Studies/Trials
• Summary of Standards Used, If Any.

6. Copyright © 2011-2013 Regulatory Doctor. All Rights Reserved. 6
Format
• Similar to the Process in Place at CDER/FDA
• Structured/Standardized – Categorized/Itemized
– Class I and Class II – Same Format
– Class III – Expanded Format with Additional Info
• Submitted in Electronic Format
• Downloadable with 510(k) Number or PMA
Number or UDI

7. Copyright © 2011-2013 Regulatory Doctor. All Rights Reserved. 7
Thank You Very Much!
REGULATORY DOCTOR
3955 Riner Road, Box #148
Riner, VA 24149
Phone: (540) 315-RAC1 (7221)
E-mail: David@RegulatoryDoctor.com
Fax: (866) 591-5671
http://www.REGULATORYDOCTOR.com