1. The Current PMA Requirements
Too Costly, Too Slow:
The Current PMA Requirements
Keith Dawkins MD FRCP FACC FSCAI
Global Chief Medical Officer
Executive Vice President
Boston Scientific Corporation

2. Conflict of Interest
Boston Scientific Corporation
Employee
Stockholder

3. Disclaimer ‘Too Costly, Too Slow: The Current PMA Requirements’
This title was chosen by Ron Waksman MD, and does not reflect the views of Boston Scientific Corporation…

4. The Perception…
‘Unpredictable, inefficient, and expensive regulatory processes are jeopardizing America’s leadership position in Medtech innovation....’
‘U.S. patients waited an average of two years longer than those in Europe to gain access to new medical technologies from the survey companies….’

5. Notification of Approval (§814.44)
PMA Review Process
File a PMA (21 CFR )
In-depth review (21 CFR )
Panel Review (21 CFR )
Notification of Approval (§814.44)

6. Steps in the PMA Application Process
ODE filing review
OSB statistical review for filing
OC review of manufacturing information for compliance with the Quality System regulation (21 CFR 820).
PMA filing decision
Day-100 Meeting
Quality System Inspection(s) by the FDA field personnel. An FDA manufacturing inspection is conducted for all original PMAs and may be conducted for PMA supplements requesting approval of alternate or additional manufacturing and sterilization facilities.
Bioresearch Monitoring (BIMO) Audit (audit of clinical study data)
Substantive review coordination and completion in areas such as:
Preparation of FDA Summary of Safety and Effectiveness Data (SSED)
Nonclinical Studies
Microbiological, Toxicological, Immunological, Biocompatibility, Shelf Life, Analytical (for IVDs), Animal, Engineering (Stress, Wear, Fatigue, etc.)]
Clinical Studies
Panel Meeting Decision and Mailing (if panel meeting is appropriate)
Panel Date (if appropriate)
Transcripts Received, Reviewed and Placed in Administrative Record
QS/GMP Clearance
Final Response from OC for GMP/BIMO
Final ODE Decision Memo
Approval Package
Approval Order, SSED, Final Draft Labeling

7. Early Communication & Collaboration…
…is the Key to Timely Device Approval

8. EFS: An alternative Pathway
Andrew Farb, MD & Dorothy Abel (CDRH)

9. Early Feasibility Study
‘FDA recognizes the value of encouraging medical device innovation to address clinical needs and improve patient care, particularly when alternative treatments or assessments are unavailable, ineffective, or associated with substantial risks to patient safety. This guidance has been developed to facilitate the early clinical evaluation of medical devices in the United States under the IDE regulations, using risk mitigation strategies that appropriately protect human subjects in early feasibility studies…’

10. ‘When approximately 81% of the applications filed in each fiscal year from 2007 to 2011 had a MDUFA decision, the average number of days to a decision decreased 32%’

11. Average Time to MDUFA Decision: PMAs
Days

12. PMAs Pending at End of Year
Days

13. Major Deficiency Letter (%)
Percentage of PMAs with Major Deficiency Letter
on 1st FDA Review Cycle
Major Deficiency Letter (%) *
*10 months

14. Medical Device User Fees (FY 2015)
Application Type
Standard
Small Business*
Pre-Market Application
$258,520
$64,630
Pre-Market Report
Panel-Track PMA Supplement
$193,890
$48,473
BLA Efficacy Supplement
180-Day PMA Supplement
$38,778
$9,695
Real-Time PMA Supplement
$18,096
$4,524
Pre-Market Notification (510k)
$5,170
$2,585
30-Day Notice
$4,136
$2,068
513(g) Request
$3,490
$1,745
Annual Fee for Class III device reporting
$9,048
$2,262
*Gross sales of $100 million or less for the most recent tax year

15. The European regulatory burden is increasing…
Notified Bodies
National Regulations
IMDRF
International Medical Device Regulators Forum
Medical Device Directive
MEDDEV
Medical Devices Guidance
ISO 14155
Clinical investigation of Medical Devices for Human Subjects (GCP)
Device Manufacturer
…which may be advantageous to the US

16. Conclusions
The regulatory burden associated with medical device approval is increasing Worldwide
The FDA is committed to a premarket review system that gives American patients timely access to safe and effective medical devices and sustains innovation in the device industry
The FDA Plan of Action to modernize and improve the premarket review of medical devices has successfully increased the predictability, consistency, transparency, efficiency, and timeliness of premarket review
Early communication & collaboration is the key to timely medical device approval