FDA & MOBILE/IT APPLICATIONS Drew Bennett Sr. Technical Licensing Specialist Office of Technology Transfer.

Slides:



Advertisements
Similar presentations
Medical Device Software Development
Advertisements

Regulatory Clinical Trials Clinical Trials. Clinical Trials Definition: research studies to find ways to improve health Definition: research studies to.
R Validation for Life Sciences Validating R for Regulated Purposes 29th July 2010 Charles Roosen (Mango Solutions) - Introduction Andrew Ellis (ETH Zurich)
SCHIE Mission To improve the quality and efficiency of health care for all stakeholders in the Santa Cruz community. To deliver technology assistance,
FDASIA Committee Background David W. Bates MD, MSc, Chair 1.
GCSE PROJECT GUIDELINES Use this presentation to make sure you have the correct content for you project - click on.
IAEA International Atomic Energy Agency Responsibility for Radiation Safety Day 8 – Lecture 4.
Advancing Excellence in America’s Nursing Homes A Review of 2 Clinical Tools: Pressure Ulcer and Restraints.
Knocking on the Door of Regulation: Unregulated Professions Seeking Regulation Jonathan Bracken Health Professions Council (UK) 2006 Annual ConferenceAlexandria,
CBER 1 Blood Establishment Computer Software (BECS) Michael Gorman, BA, MT(ASCP)SBB Consumer Safety Officer, CBER, OBRR, DBA September 15, 2009.
Physician Reminder System The Western Pennsylvania Hospital 10/3/ Earl Crane Hap Huynh Jeongwoo Ko Koichi Tominaga.
An expert system is a package that holds a body of knowledge and a set of rules on a subject that has been gained from human experts. An expert system.
Requirements for Premarket Submissions: In vitro Diagnostic Instrumentation and Software Related to Donor Screening and HIV Diagnostic Assay Systems Diane.
The Nurse Practice Act.  Defines the Nurse Practice Act and its function  Describes how the Nurse Practice Act applies to the RN Scope of Practice Objectives.
Standard 5: Patient Identification and Procedure Matching Nicola Dunbar, Accrediting Agencies Surveyor Workshop, 10 July 2012.
Copyright © 2009 by The McGraw-Hill Companies, Inc. All Rights Reserved. McGraw-Hill Chapter 5 Personal Health Records Electronic Health Records for Allied.
Radiological Devices Advisory Committee Meeting November 18, 2009 John A. DeLucia iCAD, Inc.
 Definitions  Goals of automation in pharmacy  Advantages/disadvantages of automation  Application of automation to the medication use process  Clinical.
FDA Docket No. 2004N-0133 Themes for Renewal of 21 CFR Part 11 Rule & Guidance by Dr. Teri Stokes, GXP International
Pitfalls and Lessons Learned: Advanced Implementation Strategies for a Compliant Grant Process National CME Audioconference December 9, 2008.
Product Development Chapter 6. Definitions needed: Verification: The process of evaluating compliance to regulations, standards, or specifications.
Wireless Cardiac Device Monitoring Presented by: Ashley D. Solomon, RN Nursing 457: Nursing Informatics Fall 2009.
Writing a Successful IRB Application Karen Adams Regulatory Specialist, ITHS May 17, 2013.
Europe's work in progress: quality of mHealth Pēteris Zilgalvis, J.D., Head of Unit, Health and Well-Being, DG CONNECT Voka Health Community 29 September.
Prime Responsibility for Radiation Safety
LeToia Crozier, Esq., CHC Vice President, Compliance & Regulatory Affairs Corey Wilson Director of Technical Services & Security Officer Interactive Think.
Example Template for Project Presentation
CDRH INITIATIVES FOR AGING IN PLACE NIH Aging in Place Workshop September 10-11, 2014 Presented by Mary Brady, MSN, RN Senior Policy Advisor Center for.
1 Incorporating Data Mining Applications into Clinical Guidelines Reza Sherafat Dr. Kamran Sartipi Department of Computing and Software McMaster University,
1 FAST Information System Farrokh Alemi, PhD. 2 Design Basis Interviews of interested parties Administrative Office of U.S. Courts PACTS Current system.
Medical Device Consultants, Inc. Investing in a Clinical Program: Advice in a Challenging Economic Time MassMEDIC Medical Device Clinical Trials Update.
Prof. Moustafa M. Mohamed Vice dean Faculty of Allied Medical Science Pharos University in Alexandria Development and Regulation of Medical Products (MEDR-101)
Mike Hindmarsh Improving Chronic Illness Care California Chronic Care Learning Communities Initiative Collaborative February 2, 2004 Oakland, CA Clinical.
Anyone can build a mobile App so how they heck do you govern that? BRETT POLLAK UC SAN DIEGO.
GCSE ICT Systems Analysis. Systems analysis Systems analysis is the application of analytical processes to the planning, design and implementation of.
The world leader in serving science Validation and Qualification Overview Mike Garry Software Product Manager Spectroscopy Software Platform Team.
Copyright © 2009 by The McGraw-Hill Companies, Inc. All Rights Reserved. McGraw-Hill Chapter 5 Personal Health Records Electronic Health Records for Allied.
AMERICAS | ASIA PACIFIC | EMEA Medical Devices: Concept to Commercialization How to avoid delays in getting your product cleared/approved by FDA Robert.
1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the.
DESIGNING SMARTPHONES & TABLETS INTO MEDICAL DEVICES The Allure and the Reality Presented by Doug Halperin, SUNRISE LABS 2015 Sunrise Labs1.
pag. 2 Enabling mHealth – A Lack of Progress on the Legal Front Prof. Dr. Paul Quinn Brussels Free University (Vrije Universiteit Brussel),
BSA 385 Week 3 Individual Assignment Frequent Shopper Program Part 2 Check this A+ tutorial guideline at
Chronic Care Management
Good Clinical Practice (GCP) and Monitoring Practices
Medical Device Software Development
Regulatory Updates Health Sciences Authority Singapore
FDA's Two New Draft Guidance on Software and Device
ACOEM Council on Education and Academic Affairs
European app matters Charles Lowe
1st International Online BioMedical Conference (IOBMC 2015)
Microsoft 365 Get help with regulatory compliance
Definition and Use of Clinical Pathways and Case Definition Templates
Hospice CTI Best Practice.
Office of Nuclear Materials Safety and Safeguards
9/6/2018 8:11 PM THR1046 Using Digital Experience Management to Validate the Impact of IT Change Mike Marks Product Evangelist, Riverbed © Microsoft Corporation.
INX Incontrol mobile v5 Incontrol mobile user guide
ICT meeting Business needs
Systematic Reviews and Medical Policy Determinations
HL7 International January Working Group Meeting Health Care Device WG
Software & Apps - to be a medical device or not
Data protection reform – update from the ICO
Download OriginMobile
Linda M. Chatwin, Esq. RAC Business Manager, UL LLC
Application: My rehab pro
Selecting a Health Care
Regulatory Perspective of the Use of EHRs in RCTs
Nurses Pocket guide: Nursing diagnoses, prioritizing interventions & care plan guidance Latimani Morgan To: All Nursing Department Directors & Nursing.
Human Factors in Digital Health
Part II Objectives Describe how policies and procedures are used
Connected HealthCare.
Presentation transcript:

FDA & MOBILE/IT APPLICATIONS Drew Bennett Sr. Technical Licensing Specialist Office of Technology Transfer

The challenge….

Software is… “soft” “partly invisible” “subject to change”

Facts/Clarity vs. Folklore

Actual things that I have heard people say…

Folklore  My APP does not need FDA clearance, its free…  I already got it on the APP store so it is legitimate…  We are a non-profit so our APP is not subject to FDA regulation…  My APP is not connected to any other systems so it is ‘OK’…  The FDA does not have clear guidelines so I am fine…  The FDA Guidelines are nonbinding…

Fact: The FDA does have guidance

FDA Draft Guidance – July 21, 2011 NEWS FLASH Update

FDA Updated Guidance – September 25, 2013

Clarity….sort of

That is great, because I was having trouble sleeping..

Key Guidance Points Discretionary Enforcement Specific Examples Outlined: Appendix A, B & C Medical Device APPS (Appendix C)– Sensors, Attachments, Measurements, Treatment Functions Transitional APPS (Appendix B) – Prompts, Symptom Tracking, Usage Tracking, Checklists, Notifications, Reminders Non-Medical Device APPS (Appendix C) – Education, Training, Coaching, Wellness, Office Automation/Health Care Setting Update:

I still need help, that was about as clear as…

U-M TTO Regulatory Guidance Template for Initial Regulatory Assessment of Software Applications 1.Who is the user? (e.g., Physician, nurse, patient) 2.What is the purpose of the app? (Provide a 1 paragraph description) 3.Is it intended for a specific disease or condition? If so, what? 4.It is intended to be used to screen for or diagnose a disease or condition? If so, describe. 5.What are the inputs to the app? Be specific. 6.What are the outputs of the app? Be specific. 7.If the app provides recommendation for patient treatment, briefly describe the scientific basis for the algorithm used to generate the treatment recommendations. 8.What is the hardware platform? 9.How will the software be provided? (e.g. downloaded from App store, pre-installed on hardware platform).

What is the FDA looking for? Risk - Uncertainty Process Control – SDLC/QSR – Requirements – Design & Development – Code Management – Testing & Verification – Validation & Traceability – Documentation – Security Coaching - Decision Support

“New” News

THANK YOU!