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Examples of FDA acceptable Software Design Specification (SDS)

#1
Is there a resource somewhere that provides examples of Software Design Specifications (SDS) that are acceptable for FDA submission?

I am tasked with writing one, but my company doesn't have a lot of experience with/examples of software-centric premarket FDA submissions.

Thanks,

Steve
 
Elsmar Forum Sponsor

Gisly

Starting to get Involved
#2
Hi, how far have you investigated this to date? Are you familiar with the IEC 62304, have you read up on the FDA guidance docs....? Just to better understand where to start providing some help/guidance.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#3
I am providing our 'sanitized' table of contents for our SDS.

1. PURPOSE & SCOPE
2. OVERVIEW
3. ACRONYMS and DEFINITIONS
4. REFERENCES, STANDARDS AND REGULATORY REQUIREMENTS
5. SOFTWARE CONCEPT AND DESIGN INTENT
6. SOFTWARE REQUIREMENTS SPECIFICATION
7. SOFTWARE RISK ANALYSIS
8. DEVELOPMENT PROCEDURES AND CODING GUIDELINES
9. SDS-034: About Screen
10. SDS-035: Device List Screen
11. SDS-036: Add/Edit Screen
9.xx (keep listing screens and their purpose)

This list keeps going with a section discussing each part of the software including alerts and data flow charts and user interface flowcharts.

This document was submitted and accepted by FDA in October 2020 as part of our 510(k).
 

yodon

Staff member
Super Moderator
#4
I'll echo what @Gisly suggests regarding 62304 and FDA guidance (here's the link). The level of documentation required depends on the level of concern (FDA) / software safety class (62304). You may determine (detailed) design documentation isn't even necessary!
 

Mark Meer

Trusted Information Resource
#5
I suspect that, due to the technical nature, that FDA reviewers probably don't excessively scrutinize SDS documentation.
Suggest you always consider how the document is useful/valuable to you (not just meeting anticipated requirements).

Conceptually, the SDS should allow a person (e,g, if you hired a new software developer) to understand how the software works. The specific organization/structure, and whether this is presented in flowcharts, pseudocode,... doesn't really matter as long as it's valuable to you (or, more specifically, whoever might be referencing it later-on to understand how the software works...;) ).
 

Mark Meer

Trusted Information Resource
#6
I am providing our 'sanitized' table of contents for our SDS.

1. PURPOSE & SCOPE
2. OVERVIEW
3. ACRONYMS and DEFINITIONS
4. REFERENCES, STANDARDS AND REGULATORY REQUIREMENTS
5. SOFTWARE CONCEPT AND DESIGN INTENT
6. SOFTWARE REQUIREMENTS SPECIFICATION
7. SOFTWARE RISK ANALYSIS
8. DEVELOPMENT PROCEDURES AND CODING GUIDELINES
9. SDS-034: About Screen
10. SDS-035: Device List Screen
11. SDS-036: Add/Edit Screen
9.xx (keep listing screens and their purpose)
....
Personally, my preference is that the risk-analysis & requirements specification are separated from the SDS, as they (at least for us) serve different purposes and are intended for different parties.

Generally, in our current processes:
  • The risk analysis is for a team of specialists, but should be presented in a way that anyone can read/understand. The outputs inform the requirements specification.
  • The requirements specification has input from marketing, regulatory, developers, etc., and will inform the SDS.
  • The SDS is almost exclusively by and for the software developers.
 
#7
I am somewhat familiar with IEC 62304. We have a compliance team that are more experts than I, but limited SW experience.

I guess the internal debate we're having is whether the SDS needs to enumerate specifications throughout the SDS document(s) (SDS-1, SDS-2 etc.) and each requirement must link to a specific SDS number. Or we can have sw design documents for each module (which I'm more familiar with from the commercial electronics industry) that the requirements can simply link back to the relevant design document. And then the design document lists the requirements it covers at some beginning section in the document.
 
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