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Congressional Guidance on
Substantial Equivalence
“The term "substantially equivalent" is not intended to be so narrow
as to refer only to devices that are identical to marketed devices nor
so broad as to refer to devices which are intended to be used for the
same purposes as marketed products. The committee believes that
the term should be construed narrowly where necessary to assure the
safety and effectiveness of a device but not narrowly where
differences between a new device and a marketed device do not
relate to safety and effectiveness. ”
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The 510(k) Program
“A Well Oiled Machine”
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Through the Years
• 1995
– Eliminated 510(k) Backlog
– Pilot Program for Third Party Review of Selected
510(k)s
• 1996
– Indications for use form added to all 510(k)s
• 1997
– 510(k) Change or Modification Guidance Document
– 510(k) Reengineering
– Convenience Kits Interim Regulatory Guidance
– FDAMA
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Through the Years
• 2003
– Bundling
– Expedited Review of 510(k)s--including for the
US Military and Homeland Security
– STED (Summary Technical Documentation) - A
pilot program to evaluate a proposed globally
harmonized alternative for premarket procedures
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Some 510(k)s require clinical
data...
Daily wear contact
Embolic protection lenses
devices
Vascular
CPAP devices
anastomosis devices for apnea
for CABG
Barbed sutures
Glaucoma shunts
Bone Cement
Catheter
Tier/Triage Program
• Implemented during 510(k) and PMA backlog in the
early 1990’s
– Tier III - intensive scientific and labeling review for 1st
and 2nd of a kind devices
– Tier II - routine scientific and labeling review
– Tier I - focused labeling review for indications for use
• Eliminated under 510(k) Reengineering
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510(k) & GMP
• Early 1990s implementation of the Reference List for
class I and II devices
• Followed by implementation of the Class III
510(k)/GMP Inspection Program
_____________________________________________
• 1997 - Removal of the Reference List
• 2003 - Removal of the Class III 510(k)/GMP
Inspection Program
Least Burdensome
513(i)(1)(D) states that, “Whenever the Secretary
requests information to demonstrate that devices
with differing technological characteristics are
substantially equivalent, the Secretary shall only
request information that is necessary to making
substantial equivalence determinations. In making
such a request, the Secretary shall consider the
least burdensome means of demonstrating
substantial equivalence and request information
accordingly.”
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FDAMA Exemptions from 510k
• Class I device types exempted unless for a use
which is of substantial importance in
preventing impairment of human health or
presents an unreasonable risk of illness or
injury
• Class II device types eligible if 510(k) not
necessary to assure S&E
Guidance Documents
• ODE Guidance Documents: 332
– ODE Special Control Guidance Documents: 46
• OIVD Guidance Documents: 91
– OIVD Special Control Guidance Documents: 23
• Online Publicly Searchable Database:
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfGGP/Se
arch.cfm
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CDRH Product Code Database
• Product codes are:
– The ultimate classification of a device
– Found on all 510(k) and PMA
clearance/approval letters
– Used to Search for a Predicate
– Used in Assigning FDA Inspections
– Used to Search MDRs in public database
– Used to Search Listings in public database
Recognized Standards
• CDRH has recognized approximately 800 Standards
for use in premarket review
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New Standards Form August 2007
www.fda.gov/opacom/morechoices/fdaforms/FDA-3654.pdf
Syringes
• Yesterday
– Simple barrel, rod, plunger devices
• Today
– Clever mechanical systems
– Necessitated by a need to reduce or prevent needle
sticks in the clinical setting
– Retractable needles
– Projectile rigid cover
• Today
– Image anterior/posterior segments of the eye
– Faster, increased resolution, decreased moving
parts
– Quantitative measurements
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Endoscopes
• Yesterday
– Manually guided by the physician
• Today
– Semi-Automatic Steering System
– Computer controlled system
Defibrillators
• Yesterday
– Rx Manual External Defibrillator
• Today
– OTC External Automatic Defibrillator
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Future Directions
• New FDAAA guidances on 510(k) actions and user fees
• Proposal on revised limitations to exemption from 510(k)
• Proposal on transfer of ownership for 510(k)
• Revise 510(k) Paradigm guidance
• Improve “level-playing field”
• Improve communication with CMS
• Improve IT
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