U. S. Department Of Health And Human Services

U. S. Department of Health and Human Services

Center for Devices and Radiological Health

The FDA Perspective on Open Source Software MCIM 2007 Open Source Solutions for Multi-center Image Management Session 7 May 2, 2007

Center for Devices and Radiological Health

FDA does not have a perspective on open-source software.

MCIM issues (FAQ)

Center for Devices and Radiological Health

 Imaging biomarkers 

http://www.fda.gov/oc/initiatives/criticalpath/

 When is a software product a medical

device? 

http://www.fda.gov/cdrh/devadvice/

MCIM issues (FAQ)

Center for Devices and Radiological Health

 What is the FDA perspective on open-source

software (long answer)

FDA Mission

Center for Devices and Radiological Health

 Protect and promote the public health

How Well Does It Need to Work?

Center for Devices and Radiological Health

BETTER CHEAPER FASTER

1in. = 2.54 cm. NASA Philosophy 1992—2002

MARS CLIMATE ORBITER

It’s Good Enough if . . .

Center for Devices and Radiological Health

. . . design and manufacturing processes are grounded in quality management and risk management standards (e.g., ISO 9001 and 14971), and design decisions are based on scientific and engineering principles, as evidenced by textbooks, professional literature, consensus standards, past experience.

What Are Design Controls?

Center for Devices and Radiological Health

Design controls are:  an integrated set of management practices (policies, processes, and procedures), which are  applied to design activities  to control the quality of products and services.

Process is important!

Why All The Fuss?

A Real-World Example

Center for Devices and Radiological Health

Why All The Fuss?

Center for Devices and Radiological Health

(the corporate manager’s perspective of what happened)

How Do Design Controls Work?

Center for Devices and Radiological Health

 Via mechanisms to provide visibility (i.e.,

means to measure the controlled variable) throughout the development process  Via documented procedures to exercise continuous (or at least frequent) control of resources (i.e., feedback mechanisms)  Via a semantic structure (language, taxonomy) to facilitate communications

Process is important!

REQUIREMENTS DEFINITION

PRELIMINARY DESIGN

v

DETAILED DESIGN

v

CODING

v

V V V

LEGEND v

V

=

VERIFY

=

VALIDATE

Software V&V

V & V (according to the Quality System regulation)

Center for Devices and Radiological Health

 Verification = assessing conformance to

requirements (did I do the design right?)  Validation = objective evidence that a product fulfills its intended use (did I do the right design?)  I.e., verification is details-oriented and validation is a cumulative summation of all efforts to assess suitability of design.

The bottom line …

Center for Devices and Radiological Health

 FDA doesn’t prescribe the specific design

processes appropriate for software design (or any other technology, for that matter).  In making judgments about the adequacy of design and development processes, FDA applies generally accepted principles of good design practice, as dictated by the software engineering discipline.