Center for Devices and

U. S. Department of
Radiological Health
Health and Human Services

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? Center for Devices and
Radiological Health

A Real-World Example
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 PRELIMINARY DETAILED
CODING
DEFINITION DESIGN DESIGN

v v v

LEGEND

v = VERIFY

V = 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.