Development Meeting with the FDA - Approval Pathway for a Combination Product

fialor

Involved In Discussions
#1
Hi All,
My company is at present looking to have a meeting with the FDA regarding an approval pathway for a combination product.

I would appreciate any pointers that you may have on manaing this meeting, especially if you have any experience of this.

I am aware of the FDA guidance document "Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products". Revision 2 Draft. And also the Q-Sub guidance document for device manufacturers. But any others you have would be veryhelpful.

Thank you
Fialor
 
Elsmar Forum Sponsor

shimonv

Trusted Information Resource
#3
Hi fialor,
I have only been once to a formal meeting with FDA. Just a few pointers:
1. Your questions to the agency should be crafted very carefully.
2. Your team should include all the relevent subject matter expert.
3. Despite your efforts for clarity in the meeting package, not all will understand. Therefore, aim low and walk them through the precess.
4. Take notes during the meeting to make sure capture everything.
5. Try to establish a relationship with the lead reviewer so you can contact him later on for informal questions / clarifications.
6. Stick to the agenda so you can cover all topics and reach the meeting goal.
7. In the end of the meeting, make sure you summarise the key points and get their agreement, and advise on the next steps.

Best,
Shimon
 
Thread starter Similar threads Forum Replies Date
A Are You Meeting Subcontractor (Supplier) Development Requirements? Supplier Quality Assurance and other Supplier Issues 10
D Using Laboratory Notebooks in R&D and Design and Development ISO 13485:2016 - Medical Device Quality Management Systems 3
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 4
M Clinical Development Plan - Advice Requested EU Medical Device Regulations 8
S Are risks in supply chain and development activities within scope of MDD? EU Medical Device Regulations 3
M QA/RA Professional Development Suggestions Training - Internal, External, Online and Distance Learning 6
N ISO 19011:2018 - 5.4.2 "...audit program should engage in appropriate continual development..." Training - Internal, External, Online and Distance Learning 4
DuncanGibbons Resources for aiding in procedure, work instruction and manufacturing plan development and management AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
L Design & Development of a SERVICE Service Industry Specific Topics 13
T Design Control Procedures later in the Development Process ISO 13485:2016 - Medical Device Quality Management Systems 6
K Old medical devices -> 7.3.7. Design and development validation ISO 13485:2016 - Medical Device Quality Management Systems 1
M Design Development MDR Design and Development of Products and Processes 0
O How can I justify excluding the R&D group and the design and development clause? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Ajit Basrur ISO 22379 for citywide events now in development General Information Resources 1
D CE Marking Requirements MDD & MDR - new product development covered under same scope EU Medical Device Regulations 1
G Strategy for IEC62304 implementation half way into the software development process IEC 62304 - Medical Device Software Life Cycle Processes 9
M Informational EU – Ongoing Guidance development within MDCG Subgroups Medical Device and FDA Regulations and Standards News 1
F Software development plan for SW update IEC 62304 - Medical Device Software Life Cycle Processes 2
C IATF 16949 8.3 Exclusion - Manufacturing process design and development IATF 16949 - Automotive Quality Systems Standard 5
M Software Development Company - Who would own the whole process and the certification afterwards? ISO 14001:2015 Specific Discussions 1
A Design and development of products and services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
O Software development plan : development methods IEC 62304 - Medical Device Software Life Cycle Processes 2
S ISO 9001 Clause 8.3 - Design & Development for training course center ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S ISO 9001:2015 & ISO 14001:2015 - I need a format for Design & Development planning ISO 14001:2015 Specific Discussions 2
K Templates for software development quality audit Document Control Systems, Procedures, Forms and Templates 1
DuncanGibbons Are there aerospace standards for the development and manufacture of euipment and tools? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
L AS9100 and Agile development processes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
D Electrical Safety During Medical Device Development IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
S How to consider the relevant standards during development of ISO13482:2016 for IVD manufacturing Blood grouping Other Medical Device Related Standards 6
D Medical device development - Custom test equipment ISO 13485:2016 - Medical Device Quality Management Systems 3
M Informational US FDA – Device Shortages Update: Challenges to encourage the development of new approaches to device sterilization Medical Device and FDA Regulations and Standards News 0
AlienraverX Design and Development Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
S Do we need to validate Software used in Drug discovery and development process? Qualification and Validation (including 21 CFR Part 11) 2
I QMS documents required at each stage of Software development IEC 62304 - Medical Device Software Life Cycle Processes 5
V Who should define and own the Design and Development Plan and how to maintain the updates and revisions. ISO 13485:2016 - Medical Device Quality Management Systems 2
S Development of 2xMOPP galvanic isolator for USB-connected device IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
K Design and Development Exclusion Quality Management System (QMS) Manuals 1
V Exclusion of 'Design and Development' from scope of certification ISO 13485:2016 - Medical Device Quality Management Systems 9
H Supplier Development - Distributors only? The new GM Standards IATF 16949 - Automotive Quality Systems Standard 4
cscalise Determination of CPD (Continuing Professional Development) hours for a training course Training - Internal, External, Online and Distance Learning 1
XRAY_3121 Design and Development Requirement - MDSAP Audit Finding Other Medical Device Regulations World-Wide 5
Ed Panek Splitting UI (User Interface) into two development paths 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
K Capturing local government development/planning activities in aspect register ISO 14001:2015 Specific Discussions 2
I ISO-9001:2015 - direction on New Product Development? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Informational FDA Qualifies First Biomarker Test as Part of Medical Device Development Tools (MDDT) Program Medical Device and FDA Regulations and Standards News 0
M Charging consulting fees for SOP development and guidance Document Control Systems, Procedures, Forms and Templates 13
S Internal Audit Checklist for Application/Software development IEC 27001 - Information Security Management Systems (ISMS) 1
P Performance evaluation (IVDD Annex VIII) & Design and Development Validation Studies EU Medical Device Regulations 1
M Informational USFDA Final Guidance – Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices Medical Device and FDA Regulations and Standards News 0
M 8.3.2.3 Development of products with embedded software - request for clarification IATF 16949 - Automotive Quality Systems Standard 1

Similar threads

Top Bottom