Transcript Product Development Lifecycle of Medical Devices

Development Cycle of
Medical Devices:
A Path of
Opportunities for
Information
Professionals
Donna Gay
Pharma & Health Tech Div, SLA
2007 Spring Meeting – Boston
March 19, 2007
What is a “Medical Device” ?
From section 201(h) of the Federal
Food Drug & Cosmetic (FD&C) Act:
"an instrument, apparatus, implement,
machine, contrivance, implant, in vitro
reagent, or other similar or related
article, including a component part, or
accessory which is:
recognized in the official National
Formulary, or the United States
Pharmacopoeia, or any supplement to
them,
intended for use in the diagnosis of
disease or other conditions, or in the
cure, mitigation, treatment, or
prevention of disease, in man or other
animals, or
~ from section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act
intended to affect the structure or any
function of the body of man or other
animals, and which does not achieve
any of its primary intended purposes
through chemical action within or on
the body of man or other animals and
which is not dependent upon being
metabolized for the achievement of
any of its primary intended purposes."
~ from section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act
Examples
Background
• CDRH - Center for Devices &
Radiological Health
• CFR 21, Parts 800-1299
• Device classifications: I, II, III
Medical Device Development Path
Exploration
Discovery
Development
Post-market
Exploration
Project Initiation
Discovery
Discovery
Project Chartering
Development
Development
• IDE
• PMA
• 510(k)
Launch
Post-market
Post-market
Transition
Questions
Thank You for coming
and
Thanks to my J&J Colleague,
Rengin Konuk of Ethicon
for her assistance.