# Presentation: 190279

## What’s Happening with Pediatric Medical Devices?

- Joanne R. Less, Ph.D.
- Associate Director, Clinical Research and Government Affairs
- Center for Devices and Radiological Health, FDA
- _[jrl@cdrh.fda.gov](mailto:jrl@cdrh.fda.gov)_
**(301) 827-7975**** **

## MDUFMA Pediatric Provisions

- Guidance on including pediatric expertise on advisory committees, when appropriate.
- IOM study to determine if postmarket surveillance of devices used in peds populations is sufficient to provide adequate safeguards.
- Guidance on types of S & E data needed to support marketing and on protection measures for pediatrics in clinical trials.

## Medical Devices Technical Corrections Act -- April 2004

- Report to Congress on barriers to availability of devices intended for treatment and diagnosis of diseases and conditions that affect children.
- Include recommendations for changes to law, regs, policy, or practice to encourage invention and development of ped devices.
- Due October 4, 2004.

## FR Notice Seeking Comment

- What are the unmet pediatric medical needs?  Are they in particular medical specialties? Certain subpopulations?
- What are the possible barriers? Regulatory or clinical hurdles? Economic or legal issues?
- What changes to law, regs, pre/postmarket process would encourage development of pediatric devices?

## FDA Report to Congress

- Conclusion **– Too early for policy, regulatory, or legislative changes.**
**Further study needed of scope of unmet needs, potential barriers, and solutions to them.**
**3 Recommendations:**
**Enhance communication between clinicians and device manufacturers**
**Use of children’s hospital network to aid in identification of pediatric clinical study sites.**
**Enhance use of FDA’s OPT and PAC.**

## Realized That We Do Not Know Scope of Unmet Pediatric Needs and Need to Link Barriers to Solutions

## Meetings with Stakeholders

- Pediatric professional organizations, FDA, and AdvaMed co-sponsored a series of meetings last fall.
- Interested parties included government agencies, industry, healthcare community, academia, pediatric organizations, consumers.
- Discussed unmet needs, barriers, and possible solutions to bringing ped devices to market.

##   What Are the Perceived Barriers to Pediatric Device Development?

## Barriers to Development of Pediatric Devices

- Economic
- Clinical
- Regulatory

## Economic Barriers to Development of Pediatric Devices

- Development costs for pediatric devices prohibitive – small patient population
- Liability issues
- Lack of patent exclusivity
- Lack of healthcare reimbursement
- No profit-making on HDEs

## Clinical Barriers to Development of Pediatric Devices

- Belief that pediatric trials are unethical
- Enrollment limited by:
- Prevalence of disease or condition
- Reluctance of parents, CIs, IRBs
- Concerns about exposure to additional testing (e.g., blood samples, x-rays)
- Ensuring protocol compliance/higher loss to follow-up rate
- IC and IRB requirements are difficult

## Regulatory Barriers to Development of Pediatric Devices

- Regulatory requirements not clear
- More device-specific guidance needed for new devices and for modifications to marketed devices
- Frequent size changes require additional regulatory activity, retooling, and remanufacturing

## Proposed “Solutions”

- Legislative
**Statutory presumption that adult devices should be tested for pediatrics **
- Funding/Financial
**More government grants**
**Tax credits**
**Expedited reimbursement decisions**
- Enhanced information exchange between FDA, industry, and physicians

## Proposed Regulatory “Solutions”

- Encourage peds discussions at pre-submission meetings
- Clarify marketing requirements, especially related to clinical data
- Develop more guidance for peds devices
- Develop new kind of pediatric 510(k)
- Modify HDE statute
- Add custom pediatric provision to the law

## Next Steps

- Targeted survey to help determine:
-  How we can facilitate pediatric device development under *current* law/regs.   Will providing detailed info (e.g., design, materials, or labeling changes) to manufacturers encourage new devices?
-  What *changes* to law, regs, or policy will encourage invention & development of pediatric devices?

## What Else is CDRH Doing?

- Formed a Pediatric Intracenter Working Group to:
- Facilitate pediatric premarket review consults
- Coordinate pediatric-related activities within Center
- Ensure offices are aware of various
-    pediatric issues and liaison with FDA’s
-    OPT.

## Our Challenge

- Encourage the development of new pediatric devices without:
-  Increasing the risk to pediatric
-     patients
-  Unduly increasing burden on industry
-     or FDA
-  Delaying device approvals for adults