cdrh 510(k) fdli presentation 3-26-08 -re program (00538574) (2)

8/9/2019 CDRH 510(k) FDLI Presentation 3-26-08 -Re Program (00538574) (2)

http://slidepdf.com/reader/full/cdrh-510k-fdli-presentation-3-26-08-re-program-00538574-2 1/11

The 510(k) Program

The Past, Present, & Future

Heather S. Rosecrans

Director, Premarket Notification (510(k)) Staff Center for Devices and Radiological Health

[email protected]

Congressional Guidance onSubstantial Equivalence

“The term "substantially equivalent" is not intended to be so narrowas to refer only to devices that are identical to marketed devices norso broad as to refer to devices which are intended to be used for thesame purposes as marketed products. The committee believes thatthe term should be construed narrowly where necessary to assure thesafety and effectiveness of a device but not narrowly wheredifferences 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 tomarket in US

• Used by some foreign countries for review of devices intheir country

• Valid scientific evidence required for review of 510(k)s(21 CFR 860.7)




• Most new indications for use and most new technologiesgo to market via the 510(k) path

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

• Many pre-Investigational Device ExemptionApplications (pre-IDEs) are for 510(k)s

• Many IDEs are for 510(k)s


• In 510(k), what is new today is old tomorrow! We maynot need as much data after the first few 510(k)s for anew indication for use or a new technology.

• We request performance data for new indications for useand new technologies--that do not require PremarketApproval (PMA).

• The 510(k) Program allows for innovation andflexibility, using the least burdensome provisions, toprovide 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

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


– Third Party Pilot ends, Accredited Persons Programis established

– 513(f)(2) Evaluation of Class 3 Designation (DeNovo)

– New 510(k) Paradigm Guidance– SE w/Limitations Guidance– Class II Petitions for Exemption Guidance


– Proposed 510(k) Redaction Regulation for SEDevices

• 2000– Premarket Requirements for Reprocessed Single Use

Devices• 2001

– Proposed 510(k) Rescission Regulation• 2002

– MDUFMA



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 globallyharmonized alternative for premarket procedures

Through the Years

• 2004– MDUFMA 510(k) Action and User Fee Guidances

• 2005– Format Guidance for Traditional and Abbreviated

510(k)s

Through the Years

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

agents



Some 510(k)s require clinicaldata...

Embolic protectionEmbolic protectiondevicesdevices

… requiring more in-depthreview, including occasionalPanel input.

Vascularanastomosis devices

for CABG

ImageImage --guidedguidedbronchoscopesbronchoscopes

Barbed suturesBarbed suturesGlaucoma shuntsGlaucoma shunts

Daily wear contact

lenses

CPAP devices for apnea

The number of combinationproducts is growing…

Bone CementBone Cement

CatheterCatheter

with Drugswith Drugs… necessitating new kinds of technical expertise and newregulatory paradigms.

Tier/Triage Program

• Implemented during 510(k) and PMA backlog in theearly 1990’s– Tier III - intensive scientific and labeling review for 1 st

and 2 nd 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 initialclassification of a device under paragraph (1) because of a failureto comply with any provision of this Act unrelated to asubstantial equivalence decision, including a finding that thefacility in which the device is manufactured is not in compliancewith good manufacturing requirements as set forth in regulationsof the Secretary under section 520(f) (other than a finding thatthere is a substantial likelihood that the failure to comply with

such regulations will potentially present a serious risk to humanhealth).

Least Burdensome513(i)(1)(D) states that, “Whenever the Secretary

requests information to demonstrate that deviceswith differing technological characteristics aresubstantially equivalent, the Secretary shall onlyrequest information that is necessary to makingsubstantial equivalence determinations. In makingsuch a request, the Secretary shall consider theleast burdensome means of demonstratingsubstantial equivalence and request informationaccordingly.”



FDAMA Exemptions from 510k

• Class I device types exempted unless for a usewhich is of substantial importance inpreventing impairment of human health orpresents an unreasonable risk of illness orinjury

• Class II device types eligible if 510(k) notnecessary 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/Search.cfm

Reprocessing of Single-Use Devices(SUDs)

• 2000 guidance to require 510(k)s & PMAs• MDUFMA requirements for validation data in

certain 510(k)s• GAO Report• www.fda.gov/cdrh/reprocessing/



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 ProductCode 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 Standardsfor use in premarket review



New Standards Form August 2007www.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

Optical Coherence Tomography

• Yesterday– Image of eye

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

parts– Quantitative measurements



1

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 forover 146,000 devices, each possessingincremental changes over its predicates, withFDA providing appropriate regulatory andscientific evaluation to increase access to newtechnologies and at the same time, protectingthe public health.