- To promote communication, education and mutual understanding between the local Medical Device Community and FDA.
- To act as a resource to interpret and communicate relevant medical device laws, regulations, and guidance and their implications.
- To provide regional input to CDRH.
FDA Inspections and a new compliance program
User Fee program implementation
Update from FDA Medical Device Grass Roots Committee
State device law vs FDA (www.fda.gov/OHRMS/DOCKETS/98fr/03-1435.htm)
ORCA meeting schedule
Les Weinstein, CDRH Ombudsman, February 26, 2003
Charles Breen, July 16, 2003
Meeting schedule and attendee list
Meeting Location: FDA - Bothell, Washington
Meeting Attendees: Attendee List follows
Meeting Chair: Martha Feldman, Drug and Device Development Company
Meeting start time: 13:04
Meeting minutes from 21 Oct 2002
Minutes were read and approved as written.
AGENDA ITEMS:
FDA inspections and new compliance program:
C. Breen & D. Pettenski indicated that the revised program has not yet been finalized. Many inspections need to be done per the current statutory time frame (every 2 years). The proposed "risk based approach" would prioritize manufacturer inspections based on the risk to health & welfare of public of the product:
- Class III device manufacturers never having been inspected would be highest inspectional priority.
- Class I device manufacturers would have very low priority.
- Manufacturers who are registered but do not have a product would not be formally inspected.
- For manufacturers who have been previously inspected, the return inspections would be predicated on: results of previous inspections. If the product contains software. Risk of product. Experience with product. Etc..
Issues:
- Resources for mandated 2 year inspections for all companies are not available.
- Special approvals are required for non-approved funding.
- 3rd party inspections , if/when implemented, may reduce resources to agency.
- 3rd party inspector criteria will be very rigorous.
User fee program implementation (like Drug user fee) is a possibility. However, FDA was not involved in the Drug user fee determination program.
FDA inspections/new compliance program and user fees issues will be discussed further at next meeting.
FDA Medical Device Grass Roots Committee: No information.
Regulatory Conference and ORCA Meeting schedules::
- FDLI "Introduction to Medical Device Law and Regulation" Conference in Seattle on the February 25th. Les Weinstein, Ombudsman FDA, CDRH will be in town for this.
- FDLI is offering discount to ORCA members on Round Table discussion (usually reserved for those involved in legal profession).
- Les Weinstein will be speaking at the ORCA meeting on the 26th. Location - Holiday Inn, Seattle Center.
- Charles Breen has agreed to speak at the July 16th ORCA meeting. Topic is speaker choice. CB has not yet decided on a good topic.
New Business:
1) How does State Device Law impact FDA regulstions?
Case 1 - Some states have differing ages for consent.
Case 2 - NJ - initiative to ban use of mammography based on it’s being a "fraud upon the public" (currently in state court).
Per CB: The current chief counsel seems to be using a very strict construction interpretation for The FD&C Act. No expansion of regulatory authority anticipated. There may be some backlash due to the agency’s tobacco ruling.
2) Can ORCA, the FDA Partnering committee, and/or the UW program coordinators assist in training new FDA investigators>
DP and CB do not yet know the schedule. For a recent group a national training course was 2 weeks. It included an inspection of a local medical device firm. If there is a training course held here, it will likely occur this fall. The last course was in Denver. Philips (Terry Sweeney) has offered to host a tour. Norm ? from Human Resources Development as been liaison for training Likely time for a decision will be in Spring.
3) What can be anticipated about FDA inspections of foreign manufacturing facilities? DP - probably will be pre-approval inspections. QSIT 4 days plus closeout on thte 5th. Likely focus on CAPA.
Meeting Schedule:
Next meeting tentatively scheduled for Tuesday April 8th. 9:00 a.m. - 10:30
There might be an opportunity to introduce new inspectors to the partnering group..
Meeting Adjournment:
Meeting adjourned at 13:45.
Meeting Minutes submitted by Margie van Waardenburg
Meeting Attendees:
|
Michael J. Allen |
Philips |
|
Charles Breen |
FDA |
|
Karen Browne |
Quinton |
|
Martha Feldman |
Drug & Device Development Company |
|
David Geraghty |
MicroSurgical Technology |
|
Leslie Honda |
Clear Medical |
|
Sudesh Kothari |
N/A |
|
Rob Ngungu |
NeoRx |
|
Marcia Page |
Calypso Medical |
|
Dave Pettenski |
FDA |
|
Deborah Sheffield |
Therus Corp. |
|
Betty Spann |
N/A |
|
Terry Sweeney, RAC |
Philips |
|
Margie vanWaardenburg |
Siemens |
|
Mike Willingham |
Medtronic |
