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The 510(k) Program

The Past, Present, & Future

Heather S. Rosecrans
Director, Premarket Notification (510(k)) Staff
Center for Devices and Radiological Health

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. ”

The 510(k) Program

“A Well Oiled Machine”

• Regulatory pathway by which most medical devices go to

market in US

• Used by some foreign countries for review of devices in

their country

• Valid scientific evidence required for review of 510(k)s

(21 CFR 860.7)

The 510(k) Program
“A Well Oiled Machine”

• Most new indications for use and most new technologies

go to market via the 510(k) path

• Approximately 10% of 510(k)s have clinical data

• Many pre-Investigational Device Exemption

Applications (pre-IDEs) are for 510(k)s

• Many IDEs are for 510(k)s

The 510(k) Program

“A Well Oiled Machine”
• In 510(k), what is new today is old tomorrow! We may
not need as much data after the first few 510(k)s for a
new indication for use or a new technology.

• We request performance data for new indications for use

and new technologies--that do not require Premarket
Approval (PMA).

• The 510(k) Program allows for innovation and

flexibility, using the least burdensome provisions, to
provide for reasonable assurance of the S&E of devices.

Through the Years

• Early 1990’s
– 510(k) Summary and 510(k) Statement Regulations
– Truthful and Accurate Regulation
– Reference List GMP check for class I and II devices
– Class III GMP Inspection Program
– Refuse to Accept Policy
– 510(k) Status Check Program

Through the Years
• 1995
– Eliminated 510(k) Backlog
– Pilot Program for Third Party Review of Selected
• 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

Through the Years

• 1998
– Third Party Pilot ends, Accredited Persons Program
is established
– 513(f)(2) Evaluation of Class 3 Designation (De
– New 510(k) Paradigm Guidance
– SE w/Limitations Guidance
– Class II Petitions for Exemption Guidance

Through the Years

• 1999
– Proposed 510(k) Redaction Regulation for SE
• 2000
– Premarket Requirements for Reprocessed Single Use
• 2001
– Proposed 510(k) Rescission Regulation
• 2002

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

Through the Years

• 2004
– MDUFMA 510(k) Action and User Fee Guidances
• 2005
– Format Guidance for Traditional and Abbreviated

Through the Years

• 2007
– Interactive Review
– New 510(k) Data Standards Form
– Improved Communications with CMS
– Guidance on 510(k) devices with antimicrobial

Some 510(k)s require clinical
Daily wear contact
Embolic protection lenses

CPAP devices
anastomosis devices for apnea
for CABG
Barbed sutures
Glaucoma shunts

… requiring more in-depth Image-

review, including occasional
Panel input.

The number of combination

products is growing…

Bone Cement


… necessitating new kinds of

with Drugs
technical expertise and new
regulatory paradigms.

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

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

From FDAMA: 513(f)(5)

The Secretary may not withhold a determination of the initial
classification of a device under paragraph (1) because of a failure
to comply with any provision of this Act unrelated to a
substantial equivalence decision, including a finding that the
facility in which the device is manufactured is not in compliance
with good manufacturing requirements as set forth in regulations
of the Secretary under section 520(f) (other than a finding that
there is a substantial likelihood that the failure to comply with
such regulations will potentially present a serious risk to human

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

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
• 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:

Reprocessing of Single-Use Devices


• 2000 guidance to require 510(k)s & PMAs

• MDUFMA requirements for validation data in
certain 510(k)s
• GAO Report

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

CDRH Product Code Database

• Fall 2005: CDRH released a new and improved Product
Code Database with exciting new features such as:
– Links to standards, guidance documents, Code of
Federal Regulations
– Better descriptions of device types, i.e., technical
method, target area, etc.
– Easily searchable and user friendly

Recognized Standards
• CDRH has recognized approximately 800 Standards
for use in premarket review

New Standards Form August 2007

• 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

Optical Coherence Tomography

• Yesterday
– Image of eye

• Today
– Image anterior/posterior segments of the eye
– Faster, increased resolution, decreased moving
– Quantitative measurements

• Yesterday
– Manually guided by the physician
• Today
– Semi-Automatic Steering System
– Computer controlled system

• Yesterday
– Rx Manual External Defibrillator
• Today
– OTC External Automatic Defibrillator

Anesthesiology & Respiratory Devices

• Nebulizer
– Yesterday
• Simple plastic device driven
by ventilators and/or
– Today
• Vibrating mesh type devices
with software and electronic

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

The 510(k) Program

“A Fine Tuned, Well Oiled Machine”

• Since 1976 FDA has reviewed 510(k)s for

over 146,000 devices, each possessing
incremental changes over its predicates, with
FDA providing appropriate regulatory and
scientific evaluation to increase access to new
technologies and at the same time, protecting
the public health.