# Presentation: 097235

## Getting Your Device to Market:  Regulatory Pathways

- Paul A. Williams
- Program Operations Staff
- SBIR/STTR Program
- June 2, 2003

## Presentation Outline

- Definition of “Device”
- Device Classification (Class I, II, and III)
- Regulatory Pathways
- Premarket Notification (510(k))
- Premarket Approval (PMA)
- Product Development Protocol (PDP)
- Humanitarian Device Exemption (HDE)
- Collection of Clinical Data
- Investigational Device Exemption (IDE)

## What is a “Device”?

- An instrument, apparatus, implement, machine, contrivance, implant, *invitro* reagent, or other similar or related article
- Intended to:
- diagnose disease/condition;
- cure, mitigate, treat, or prevent disease;
- affect the structure/function of the human body; and
- does not achieve primary purpose chemical action and is not dependent upon being metabolized

- Sec. 201(h) of Federal Food, Drug, and Cosmetic Act

## Regulate Through Controls

- General Controls
- prohibition against adulteration and misbranding
- registration of the family
- listing of the device
- submission of marketing application (510(k), PMA, HDE)
- GMP’s
- Record keeping
- Special Controls
- performance standards
- postmarket surveillance
- guidance documents (for clinical data, special labeling, etc.)
- patient registries

## Device Pyramid (Classification)

- Class I devices
- low risk
- 46% of all devices

- Class II devices
- moderate risk
- 47% of all devices

- Class III devices
- moderate and high risk
- <10% of all devices

- General Controls

- Special Controls

## Regulatory Pathways

- Premarket Notification (510(k))
- Class I and II, handful of III
- Premarket Approval (PMA)
- Class III
- Product Development Protocol (PDP)
- Class III
- Humanitarian Device Exemption (HDE)
- Class III

## All Devices

- Class I:  786 of which 729 are 510(k) exempt
- Class II:  860 of which 68 are 510(k) exempt
- Class III:  100

## Premarket Notification (510(k))

- “Me-too” devices
- must establish substantial equivalence  (SE) to predicate device to go to market
- predicate device – legally marketed device that is not subject to PMA, PDP, or HDE
- if not SE, then Class III
- 90 day review time

## Premarket Approval (PMA)

- device must be shown to have “a reasonable assurance of safety and effectiveness”
- safety –probable benefits outweigh the probable risks
- effectiveness – provides clinically significant results in a significant portion of the target population
- Advisory panel input
- 45 days to file; 180 days to review

## “Valid Scientific Evidence”

- The valid scientific evidence used to determine effectiveness shall consist of:
- well-controlled studies
- partially controlled studies
- objective trials w/o matched controls
- case histories
- significant human experience

## Product Development Protocols (PDPs)

- Similar to PMA
- establish safety & effectiveness
- bench, animal, and human testing
- Different from PMA
- approval based on protocol (hypothesis, objectives, endpoints, etc.) before study starts

## Humanitarian Device Exemption (HDE)

- devices for the txt or dx of diseases affecting < 4,000 pts. in US/yr.
- device otherwise not available
- no alternative device
- exemption form effectiveness
- safety threshold is different than PMA

## HDE Approval Threshold

- device will not expose patients to unreasonable or significant risk of illness or injury
- probable benefit outweighs the risk of injury or illness
- taking into account the probable risks and benefits of currently available devices or alternative forms of treatment

## Specifics of an HDE

- IRB approval and oversight required
- Informed consent not required
- Subject to GMPs
- Cannot make a profit
- 75 day review time

## Investigational Device Exemption (IDE)

- When is clinical data needed?
- to support:
- PMA and PDP (almost always)
- 510(k) (<10%)
- new indication for an approved device
- significant change to device, especially Class III devices

## Study Determinations

- Significant Risk Study (SR)
- FDA approval required
- IRB approval required
- Informed consent required (IC)
- presents a potential serious risk to the health, safety, and welfare of a subject and is:
- an implant; or
- life supporting or sustaining; or
- of substantial importance in diagnosing, curing, mitigating, or tx disease or preventing impairment of human health
- Non-significant Risk Study (NSR)
- No FDA approval required
- IRB approval required
- IC required
- subject to the abbreviated requirements of 21 CFR 812

## Process of IDE Submission

- Administrative review
- Refuse to Accept Policy (RTA)
- 15 days to issue RTA letter
- Scientific review
- scientific soundness
- safety, risk to patient
- IC for compliance with Part 50
- Decisions
- Approval
- Conditional Approval
- Disapproval
- 30 days to issue letter

## References

- 21 CFR 807 Subpart E (510(k))
- staff (301) 594-1190
- 21 CFR 814 (PMA)
- staff (301) 594-2186
- 21 CFR 814 Subpart H (HDE)
- staff (301) 594-1190
- 21 CFR 812 (IDE)
- staff (301) 594-1190
- Device Advice
- _[http://www.fda.gov/cdrh/devadvice/index.html](http://www.fda.gov/cdrh/devadvice/index.html)_
- FDA homepage
- _[http://www.fda.gov/](http://www.fda.gov/)_