how to prepare a medical device 510(k) submission for the fda...for software contained in medical...
TRANSCRIPT
Slide 1
Rob Packard, President
www.MedicalDeviceAcademy.com
How to Prepare a Medical Device 510(k) Submission for the FDA
October 25 @ Noon EDT
Slide 2
Rob Packard, President
www.MedicalDeviceAcademy.com
510(k) Coursehttps://medicaldeviceacademy.com/510k-course/
Slide 3
Rob Packard, President
www.MedicalDeviceAcademy.com
How Long ?
BeginDHF
510(k)Clearance
Design Transfer
Pilot Phase Release Phase
HazardIdentification
Risk ControlOption Analysis
Risk Evaluation
RiskEstimation
Risk Control Effectiveness Verification
Risk Management
Plan
RequestPre-SubMeeting
Pre-SubMeeting
Begin510(k)
Submit510(k)
Development PhaseFeasibility PhaseConcept Phase
90+ Days100 Days60-75 Days
RiskManagement
Review
Benefit/RiskAnalysis
Evaluation of Overall Residual Risk
https://medicaldeviceacademy.com/risk-management-training-webinar/
Slide 4
Rob Packard, President
www.MedicalDeviceAcademy.com
How Much $
• 510(k) Pre-sub – No FDA user fee• 510(k) Submission:
– $10,953 is standard user fee (FY 2019)– $2,738 is small business fee (FY 2019), but prior qualification is required
• Regulatory Consulting Fees:– $2,181 is pre-sub consulting fee– $10,911 is 510(k) consulting fee ($12,000 for both)
• Biocompatibility Testing = $13,000 min.• Electrical Safety & EMC Testing = $50,000 min.• Benchtop Testing ? – Product Specific• Animal Testing - $100K+• Clinical Study - $1 million+
Slide 5
Rob Packard, President
www.MedicalDeviceAcademy.com
510(k) Process
Slide 6
Rob Packard, President
www.MedicalDeviceAcademy.com
Product Classification
1. Identify a device similar to yours
2. Use the registration and listing database
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
3. Identify the 3-letter product code
4. Click on the code to go to the product
classification page
http://medicaldeviceacademy.com/fda-device-classification/
Slide 7
Rob Packard, President
www.MedicalDeviceAcademy.com
Find Classification Other Wayshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm
Slide 8
Rob Packard, President
www.MedicalDeviceAcademy.com
Substantial Equivalencehttps://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Guidanc
eDocuments/UCM284443.pdf
Slide 9
Rob Packard, President
www.MedicalDeviceAcademy.com
Use ToC as Planning Tool
• red = the information does not appear to be available
• yellow = document requires revision and/or reformatting of content
• blue = ready for the client’s review and approval
• green = ready for submission
• Add a column to assign team responsibilities
• Prioritize task completion
Slide 10
Rob Packard, President
www.MedicalDeviceAcademy.com
ToC Examplehttps://medicaldeviceacademy.com/510k-project-management-lessons-learned/
Slide 11
Rob Packard, President
www.MedicalDeviceAcademy.com
Planning Performance Testing
• Look for a special controls guidance document 1st.
• Look for any device-specific standards (e.g., ASTM F483)
• Review each of the possible 510(k) Summaries carefully
• Order 510(k) submissions through FOI
https://medicaldeviceacademy.com/design-controls-training-webinar/
Slide 12
Rob Packard, President
www.MedicalDeviceAcademy.com
FDA Pre-Sub Meetings
• Guidance released September 29, 2017
• Consultants and RA Experts have used these for years, but weren’t called “pre-sub” meetings
• Do your homework 1st
• In-person vs. Tcon
• Timing = Prior to Performance Testing
• Identify Proposed Predicate Device(s)
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM311176.pdf
Slide 13
Rob Packard, President
www.MedicalDeviceAcademy.com
Changes to RTA process
• Guidance released January 30, 2018
• Longer checklist
• Can be rejected multiple times
https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm315014.pdf
Slide 14
Rob Packard, President
www.MedicalDeviceAcademy.com
Human Factors Guidance
• Guidance released February 3, 2016• Min. 15 users per user group• Users must be representative of US population• Seldom able to use Usability Report from European
Technical Files “as is”• Must perform risk analysis to determine risks that
will be evaluated in the human factors study• Almost always required for OTC products• Not commonly required for orthopedic surgical
implants unless technique or design is unique
https://www.fda.gov/downloads/medicaldevices/.../ucm259760.pdf
Slide 15
Rob Packard, President
www.MedicalDeviceAcademy.com
eCopy Hold
If you are using Windows 10, and you save your eCopy or eSubmitter zip folder on a flash drive, Windows 10 will automatically create a hidden system folder titled:
“System Information Volume”
https://medicaldeviceacademy.com/ecopy-hidden-system-files/
Slide 16
Rob Packard, President
www.MedicalDeviceAcademy.com
Changes to eCopy process
• Unofficial change in February 2018…only printed copy cover letter with electronic copy
• Different from eSubmitter
https://medicaldeviceacademy.com/fda-ecopy-webinar/
Slide 17
Rob Packard, President
www.MedicalDeviceAcademy.com
software status
• eSubmitter Options:
– Template Ver. 1.3 (IVD)
– Template Ver. 1.2.1
– Template Ver. 3.2, Quik 510(k) Pilot
https://www.fda.gov/forindustry/fdaesubmitter/default.htm
Slide 18
Rob Packard, President
www.MedicalDeviceAcademy.com
Quik 510(k) Pilot
1. Refusal To Accept (RTA) Process is eliminated2. Review is interactive3. 60-Day Review “Clock”
https://medicaldeviceacademy.com/quik-510k-pilot/
Slide 19
Rob Packard, President
www.MedicalDeviceAcademy.com
Small Business Qualification Changes
• Form was split from guidance
• Can apply as early as August 1
https://medicaldeviceacademy.com/small-business-qualification-fee-webinar/
Slide 20
Rob Packard, President
www.MedicalDeviceAcademy.com
Interoperability Guidance
• Guidance released September 6, 2017
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM482649.pdf
Slide 21
Rob Packard, President
www.MedicalDeviceAcademy.com
Device Modification Guidances
• https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm514771.pdf - Changes to devices
• https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm514737.pdf - Changes to software
Slide 22
Rob Packard, President
www.MedicalDeviceAcademy.com
Impact of De Novo Fee Changes
MDUFMA IV = De Novo is no longer free, but the FDA’s target completion date for making a decision on your De Novo application is 150 days.
• $96,644 is standard user fee (FY 2019)
• $24,161 is small business fee (FY 2019), but prior qualification is required
Slide 23
Rob Packard, President
www.MedicalDeviceAcademy.com
Software Requirements
• Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices –Guidance for Industry and FDA Staff, May 2005
• General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 2002
• Guidance for Off-The-Shelf Software Use in Medical Devices
• IEC 62304 Edition 1.1 2015-06 Medical device software – Software life cycle processes
Slide 24
Rob Packard, President
www.MedicalDeviceAcademy.com
Software Standards
Slide 25
Rob Packard, President
www.MedicalDeviceAcademy.com
Software Documentation
Slide 26
Rob Packard, President
www.MedicalDeviceAcademy.com
Cybersecurity Policies
• Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - October 2, 2014
• Postmarket Management of Cybersecurity in Medical Devices - December 28, 2016
• Cybersecurity for Networked Medical Devices Containing Offthe-Shelf (OTS) Software - January 14, 2005
Slide 27
Rob Packard, President
www.MedicalDeviceAcademy.com
UDI Example
Slide 28
Rob Packard, President
www.MedicalDeviceAcademy.com
UDI & GUDID
• UDI = Unique Device Identifier
• GUDID = Global Unique Device Identifier Database
• All questions specific to the UDI or GUDID should be directed to the UDI Help Desk
• Next Deadline is September 24, 2018– Physically on devices that are Class II
– Labeling for Class I
– Labeling for Unclassified Devices
Slide 29
Rob Packard, President
www.MedicalDeviceAcademy.com
FDA Biocompatibility Guidance
• Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process“ – released June 16, 2016
• http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm348890.pdf
Slide 30
Rob Packard, President
www.MedicalDeviceAcademy.com
RTA Checklist
• Section G – Biocompatibility– Submission must state one of the following…
• Direct or indirect patient contacting parts
• Contact information not needed…why? (e.g. software)
– Submission includes a list of all patient contacting parts and associated materials including coatings and colorants
– Type and duration of contact is specified
– Biocompatibility Assessment• Test protocol with description of test article, methods, pass/fail
criteria and results for each test
• Or Statement that testing is not required with a rationale
Slide 31
Rob Packard, President
www.MedicalDeviceAcademy.com
New ISO 10993-1:2018
Only 1 Required Input:
• “physical and/or chemical information”
Expansion of Endpoints to be Considered:
• “material mediated pyrogenicity”
• “chronic toxicity”
• “carcinogenicity”
• “reproductive/developmental toxicity”
• “degradation”
Slide 32
Rob Packard, President
www.MedicalDeviceAcademy.com
New Definitions
21 New Definitions:
• “3.9 geometry device configuration”
• “3.15 nanomaterial”
• “3.16 non-contacting”
• “3.17 physical and chemical information”
• “3.25 toxicological threshold”
• “3.26 transitory contact”
Slide 33
Rob Packard, President
www.MedicalDeviceAcademy.com
Q & A
If you would like to schedule a call with me, please use the following link:
https://calendly.com/13485cert/30min
Slide 34
Rob Packard, President
www.MedicalDeviceAcademy.com
Rob Packard
+1.802.281.4381
rob13485
Contact Info