1. GCP AND MEDICAL DEVICES
DIA GCP/QA ALL SIAC CALL
23 OCT 2008
Maryrose Petrizzo, MS
Manager, Clinical QA, Boston Scientific

2. WHAT IS A DEVICE?
A device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is–
recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,

3. WHAT IS A DEVICE?
intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
FD&C Act Part II Sec. 201 (h)

4. DEVICE CLASS
Class I devices are subject to the least regulatory control. They present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Class I devices are subject to "General Controls" as are Class II and Class III devices.
Examples: elastic bandages, exam gloves

5. DEVICE CLASS
Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assurances. In addition to complying with general controls, Class II devices are also subject to special controls.
Examples: powered wheelchairs, infusion pumps

6. DEVICE CLASS
Class III is the most stringent regulatory category for devices. Class III devices are those for which insufficient information exists to assure safety and effectiveness solely through general or special controls.
support or sustain human life,
are of substantial importance in preventing impairment of human health,
or which present a potential, unreasonable risk of illness or injury.
Examples: replacement heart valves, breast implants

7. GCP Similarities with Drug Trials
Part 11 – Electronic Records and Signatures
Part 50 – Protection of Human Subjects
Part 54 – Financial Disclosure by Clinical Investigators
Part 56 – Institutional Review Boards

8. Drugs vs. Devices Parts 312 vs. 812
Investigational New Drug Application vs. Investigational Device Exemptions
NDA vs. Premarket Notification510(k), Premarket Approval,
510(k) – to show Substantial Equivalence and gain “clearance” most Class I and some Class II
PMA – Significant Risk device that you want “approved” for market most Class III not SE

9. Differences from Drug Trials
Terminology
Drug studies are usually much larger than IDE studies, although post-market studies of devices can be large registry trials.
Blinding is often not possible for devices
Placebo control is often not possible
Many device studies are not interventional
Many device studies augment other therapies/procedures

10. Differences from Drug Trials
1572 vs. Investigator Agreement
IA must be signed by all clinical investigators, including sub-I’s.
Need CVs and FDs for all who sign.

11. Differences from Drug Trials
Adverse Event Reporting – IND Safety Reports (312.64)
An investigator shall promptly report to the sponsor any AE that may reasonably be regarded as caused by, or probably caused by, the drug. If the AE is alarming, the investigator shall report the AE immediately.

12. Differences from Drug Trials
Medical Device Reporting (803.3)
MDR events:
An event that Sponsor becomes aware of that reasonably suggests that a device has or may have caused or contributed to a death or serious injury; or
that one of their marketed devices:
may have caused or contributed to a death or serious injury, or
Has malfunctioned

13. Differences from Drug Trials
Unanticipated Adverse Device Effects ( )
An investigator shall report to the sponsor and the IRB a report of any UADE occurring during an investigation as soon as possible, but no later than 10 working days after the investigator first learns of the UADE.

14. MEDICAL DEVICE STUDY CHALLENGES
GMP mentality
Marketing Driven
GCP and Post-market studies
Combination Products
Comparator studies to drugs or surgery
Drug studies setting the bar high for GCP

15. FUTURE
Medical Device clinical research continues to be evolving, fast-paced, and interesting arena for GCP/QA personnel
Increasing number of medical device company representatives attending DIA events.
Is there a need to create a GCP/QA working group ?

16. THANK YOU
Contact Info
Maryrose Petrizzo
(302)