1 The 510(k) Program The Past, Present, & Future Heather S. Rosecrans Director, Premarket Notification (510(k)) StaffCenter for Devices and Radiological Health [email protected]240-276-4021 Congressional Guidance on Substantial Equivalence “The term "substantially equivale nt" 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” • Regul atory pat hway by wh ich most medical devices go to market in US • Used by some foreign cou ntries for review o f devices i n their country • Valid sci entifi c evidenc e require d for review of 51 0(k)s (21 CFR 860.7)
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CDRH 510(k) FDLI Presentation 3-26-08 -Re Program (00538574) (2)
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8/9/2019 CDRH 510(k) FDLI Presentation 3-26-08 -Re Program (00538574) (2)
“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)
8/9/2019 CDRH 510(k) FDLI Presentation 3-26-08 -Re Program (00538574) (2)
• 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
The 510(k) Program“A Well Oiled Machine”
• 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
8/9/2019 CDRH 510(k) FDLI Presentation 3-26-08 -Re Program (00538574) (2)
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.”
8/9/2019 CDRH 510(k) FDLI Presentation 3-26-08 -Re Program (00538574) (2)
• 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
– 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
8/9/2019 CDRH 510(k) FDLI Presentation 3-26-08 -Re Program (00538574) (2)
• 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.