DHF structure for accessories to a parent device

racglobal

Involved In Discussions
#1
My company produces a Class I electromechanical device (according to US classification). The company plans to introduce software accessories to the parent hardware device to extend its capabilities. The new features will introduce new indications that will require a 510(k). These accessories will be add-ons . The plan is to manufacture a base unit with all necessary hardware and then control access to the new features through software licenses. The base unit would still be Class I, but the individual software modules will be subject to a 510(k).

What is the best strategy to manage the DHF of the parent device + software accessories and later the 510(k) submission? How do we draw the line between the parent device and the accessory? One approach is to create one set of documents merging both the parent device and the accessory device and then flag those documents that are specific to the accessory. Again, this can be difficult because the accessory and the parent share a lot of the same documentation. Does it make sense to create one DHF for the parent, and X # of DHFs for the # of accessories. Another concern is how to present the 510(k) information to the FDA so that we make it clear the Class II accessories are in scope without also having the FDA treat the Class I parent device as a Class II since we cannot present Class II information without bringing in the Class I parent device.

Thank you. I look forward to your response.
 
Elsmar Forum Sponsor

ECHO

Involved In Discussions
#2
I am a bit confused on how your accessory can be Class II but your parent device be a Class I. Would you be able to describe your intended use?
I have only seen cases where the parent device is equal or higher than the child device.

That said, we always had 1 DHF for the parent and a DHF for each child device. As to duplicated documents, our DHFI pointed to the same documents.
 
Thread starter Similar threads Forum Replies Date
J How to structure a DHF when all manufacturing is done by Contract Maufacturers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S Audit Finding - Design History File (DHF) Index: few (3 to 4) reports not identified ISO 13485:2016 - Medical Device Quality Management Systems 3
G Why doesn't the BOM go in the DHF? Other Medical Device and Orthopedic Related Topics 9
K Design History File - Looking for Examples of DHF's. 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
MrTetris TF vs DHF CE Marking (Conformité Européene) / CB Scheme 2
S DHF/DMR/MDF for a software-only, cloud-based, single-instance device Medical Information Technology, Medical Software and Health Informatics 2
D Design controls - Inputs, outputs, V&V, DHF, DMR ISO 13485:2016 - Medical Device Quality Management Systems 10
A FDA and NB audit of Engineering Drawings in DHF and DMR. Medical Device and FDA Regulations and Standards News 1
D DHF Responsibility after design handover Document Control Systems, Procedures, Forms and Templates 4
R Suggestions for putting together a DHF (Design History File) ISO 13485:2016 - Medical Device Quality Management Systems 3
P DHF, DMR and DHR in MDR? EU Medical Device Regulations 6
A DHF File - Shall the document cover all the variants? Design and Development of Products and Processes 2
S Our products borrow DHF documents from a previous DHF for another product ISO 13485:2016 - Medical Device Quality Management Systems 2
S Is an index necessary for DMR or DHF? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
S DHF File Change Control Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C Per IEC 62304, are DHF documents Configuration Items? IEC 62304 - Medical Device Software Life Cycle Processes 8
A Hundreds of Medical Devices & Accessories - 3 DHF's? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
E Updating DHF (Design History File) to include Alternative Component 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
V What is required in terms of the DHR, DMR, DHF? Other Medical Device and Orthopedic Related Topics 4
K ISO 13485 and DHF (Design History File) requirements ISO 13485:2016 - Medical Device Quality Management Systems 9
O Distributors and ISO 13485 - DHF and DMR Responsibilities ISO 13485:2016 - Medical Device Quality Management Systems 7
M Design History File (DHF) for New Generation of Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
E Design Dossier/DHF Updates - What to Keep EU Medical Device Regulations 2
N 510k without DHF (Design History File) that we bought a 3 years ago US Food and Drug Administration (FDA) 4
D Incomplete DHF: Re-do or plug gaps? Design and Development of Products and Processes 6
A DHF (Design History File) for a Legacy Product (Class iii Medical Device) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
B When To Share Your DHF (Design History File) With A Customer US Food and Drug Administration (FDA) 1
K Retrospective DHF for an old non-registered device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S Cost Targets as Design Inputs in your DHF (Design History File) US Food and Drug Administration (FDA) 7
renenatasha Usage of web articles in DHF (Design History File) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
A Medical Device DHF (Design History File) - One per Design Change? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
L Creating DHF (Design History File) for Medical Device Systems Design and Development of Products and Processes 8
K How to start a Design History File (DHF) for Medical devices Company 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R Design History File DHF Practices and Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D Design History File (DHF) - Buy-For-Resell Products 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
D DHF Review - When does the FDA review the DHF? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M What are typical Roles & Responsibilities of DHF (Design History File) Librarian? US Food and Drug Administration (FDA) 6
N Control of Medical Device DHF (Device History File) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
H Paper based DHF (Design History File) updates for Software Updates 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Q DMR-Device Master Record vs DHF-Design History File vs DHR-Device History Record 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 50
C Remediating a Design History File (DHF) for an IVD developed prior to 1997 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Design History File (DHF) Maintenance Information wanted 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
O DHF (Design History File) Template Other US Medical Device Regulations 13
H Working from a previous design history. How can I best leverage the exisitng DHF? Other US Medical Device Regulations 4
C How to establish a Design History file (DHF)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
W Update DHF (Device History Record) when DMR (Device Master Record) changes? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
V Medical Products: CE Marking - Are the DMR's, Technical Files, DHF, required? EU Medical Device Regulations 6
W Design History File (DHF) Template Example for Consideration. Design and Development of Products and Processes 12
S Which documents in the DHF (Design History File) should be controlled? ISO 13485:2016 - Medical Device Quality Management Systems 2
T DMR/DHF/DHR/Batch Records/Master Batch Records ISO 13485:2016 - Medical Device Quality Management Systems 3

Similar threads

Top Bottom