Joseph C. Griffin

Joseph C. Griffin, III
Medical Device Regulatory Affairs / Quality Assurance
Experience and Accomplishments

>>>>>>>>>>>>>PMA Applications<<<<<<<<<<<<
ALERT® System Premarket Approval (PMA) Application
Multi-electrode Array Catheter and Defibrillator/ Computer used for internally converting patients w/ atrial fibrillation using low energy (1j) from a catheter instead of high energy (360j) external paddles.

Regulatory Body: US Dept. of Health and Human Services/ Food and Drug Administration
Event: Class III Device “Modular” Premarket Approval (PMA) Application Submission for the ALERT® System consisting of the ALERT Catheter, ALERT Interface Cable, and ALERT Companion with Software Version 1.08. All Modules were submitted with the exception of the Clinical Trial Data Module which was pending statistical analysis conclusion.
Device Classification Name: system, pacing, temporary, acute, internal atrial defibrillation
Date(s): 11/01/1999 received by FDA – 11/27/2002 decision by FDA 06/24/2003 notice of FDA approval
Result(s): Received and accepted as complete and reviewable on 1st attempt.
Action(s): Follow up with Clinical Trial Data Module
Outcome: PMA No. P990069, Docket No. 03M-0240, Product Code MTE, Submitted Modules were approved during my period in office. Final PMA Approval was subject to Clinical Trial Module Approval and “compliant” PMA facility inspection and cGMP and QSR audit. I was consulted during final phase.
Comments: I made the strategic decision to not wait for the conclusion of statistical analysis of clinical trial data and take advantage of a new program that the FDA was experimenting with that allowed massive PMA Class III device submissions to be submitted in modules that pertained to the specific expertise groups within the Office of Device Evaluation (ODE). This saved the Company over one year in total approval time. During this process I had face to face meetings with all reviewing parties within the FDA ODE, including the director, Dr. Susan Alpert, at the Rockville, MD complex. I also worked closely, on a biweekly basis, via telephone and e-mail, with the lead reviewer Carol Carry up to receiving approval of the Modules submitted. Most importantly, I was hands-on involved in the generation and collection of the necessary internal design and manufacturing documentation, US certifications, collateral standards compliance certifications, and the overall structure of this several thousand page document. With my signature, I took total responsibility for the truthfulness and accuracy of the submission.

>>>>>>>>>>>>>IDE Applications<<<<<<<<<<<<
Flexible Stenting Solutions' IDE Application information is currently confidential.
Prepared IDE application for EP MedSystems' ALERT® System.


>>>>>>>>>>>>>FDA Establishment Inspections<<<<<<<<<<<<<
Regulatory Body: US Dept. of Health and Human Services/ Food and Drug Administration
Event: Facility Inspection, cGMP and QSR Audit
Date(s): June 3, 4, 5, and 9, 1998
Result(s): One minor FDA-483 observation: QA Manager performed the internal audit of the QA department which the FDA considers quality bias.
Action(s): Being qualified, I performed the audit of the QA department over the weekend and documented the results prior to the FDA CSO’s return on the 9th.
Outcome: The FDA-483 that the CSO’s prepared prior to arrival on the 9th was amended to note that the 1 item observed was corrected by the Company and verified on-site by the FDA. No further action or reporting was required by the Company.
Comments: Code of Federal Regulations (CFR) Design Control requirements went into effect June 1, 1998, which, one year prior I started preparing for compliance. I personally handled the Consumer Safety Officers during this inspection/ audit.

>>>>>>>>>>>FDA Inspection Note<<<<<<<<<<<<
Over my career I participated in well over a dozen FDA inspections: some with FDA-483 items requiring a response, corrective action plan and satisfactory close-out with FDA resulting in no Warning letters; most inspections concluded without FDA-483 items and no Warning letters; and only one FDA-483 item resulting in a Warning letter around 1990 (during a new venture start-up where resources were scarce) which was promptly rectified within weeks. I directly handled the CSO’s for the majority of these establishment inspections and audits.

>>>>>>>>>>>>Citizen Petitions to FDA<<<<<<<<<<<<<
Regulatory Body: US Dept. of Health and Human Services/ Food and Drug Administration
Event: All, industry-wide, Electrophysiology and Pacing Catheters having exposed male 2mm connector pins could no longer be sold after 05/09/2000 as mandated by 21 CFR 898.13(b) to prevent accidental electrocution of patients by untrained hospital personal plugging a 2mm pin into a 110v wall outlet or power cord. As idiotic as it sounds, someone in a hospital actually killed a patient and thus the new standard, of which, “industry” agreed with. Even though we were in agreement, new compliant part suppliers could not meet demand to make our finished product compliant. In order to protect my employer from FDA enforcement action, I petitioned the FDA to grant the Company a 90 day variance in the compliance date to 08/09/2000 and, during such time, allow us to continue supplying product with exposed 2mm pins.
Date(s): 05/05/2000 petition received by FDA – 06/06/2000 decision by FDA
Action(s): FDA investigated supply and demand for “new standard compliant 2mm pins” and reviewed petition. FDA requested that we send letters to our customers stating that once new protected pins are shipped to them they must exhaust inventory of any exposed 2mm before using new style.
Outcome: “Petition Granted” by FDA as requested on 06/15/2000.
Comments: I crafted a very persuasive petition letter to the FDA pointing out the impact on healthcare facilities and doctors not being able to provide adequate care to patients because of product shortages. Shortages caused by the lack of sufficient raw material supply to bring finished goods into compliance with the new protective connector pin standard. In addition to making my case by means of patient benefit vs. patient risk, I specifically asked that FDA exercise prosecutorial discretion in enforcement of the standard for 90 days.

>>>>>>>>>>>>Quality System Certifications<<<<<<<<<<<<
Obtained Full Scope ISO 13485:2003 Quality Management System Certification for Flexible Stenting Solutions, Inc. for the design and manufacture of vascular stents.
Obtained ISO 9001:1994 and BS EN 46001:1997 Quality Systems Certification for the Design and Manufacture of all of EP MedSystems Medical Device Products on 01/31/1997, Certificate No. 106, from AMTAC Certification Services Limited, an Officially Registered Notified Body of the European Union (EU). At the same time, I obtained ISO 13485:1996 quality systems compliance certification for the Company’s Class III ALERT® Defibrillation system. These certifications were an enormous accomplishment. It took eighteen months of dedicated hard work converting the way the day to day operation of the design and manufacture of Company’s products were carried out and documented. It also required a lot personal persuasion on my part of all Company employees to accept this dramatic change in how the Company functioned. I personally orchestrated all activities in this endeavor, most of which we hands-on.

The Company could not have obtained CE Marking certification for any of its products for sale in Europe without first obtaining this crucial prerequisite certification.

>>>>>>>>>>>CE Mark Authorizations<<<<<<<<<<
Obtained CE 0000 Marking Authorization on all Class IIb devices manufactured by Flexible Stenting Solutions including Biliary Stents and Femoropopliteal (SFA/Pop) Stents.
Obtained CE 0473 Marking Authorization on all Class II devices manufactured by EP MedSystems upon completion of compliance review of each individual product group design dossiers, submitted to the EU Notified Body, compiled to demonstrate compliance with ANNEX II of the MEDICAL DEVICE DIRECTIVE (MDD) 93/42/EEC on 01/31/1997. For CIass III devices I personally compiled each design dossier and drafted the majority portion of the content necessary to gain Class III CE Mark Authorization.

>>>>>>>>>>>>EC Declaration of Conformity<<<<<<<<<<<<<
I prepared and executed an “EC Declaration of Conformity” to Council Directive 93/42/EEC for each company Product Group. With my signature I took legal responsibility for medical device conformity.

>>>>>>>>>>>>Product Recalls (Voluntary)<<<<<<<<<<<<<
Regulatory Body: US Dept. of Health and Human Services/ Food and Drug Administration
Event: I initiated a voluntary Class II Device recall for a small population of electrophysiology catheters having a soft flexible segment at the tip of a braided catheter shaft where the tip and shaft were not sufficiently welded together by our vendor and when being flexed in the heart at body temperature, could separate and cause vessel trauma upon removal. However, the soft tip is anchored by conductor wires so there was never a risk of it becoming detached in the heart requiring surgical intervention.
Device Classification Name: catheter, electrode recording, or probe, electrode recording
Date(s): Notified FDA and initiated voluntary recall sometime around 1994-1995.
Action(s): Recall classified as a Class II recall, where there is either a possibility that the device will cause temporary or reversible health problems, or there is a remote chance that the device will cause serious health problems. I notified our customers (i.e. distributors or direct sale) and asked them to notify the intended recipients (end-user) of the devices that they are being recalled and to immediately return the product for replacement or credit. All effected product was identified as either consumed or returned to the Company thus accounting for all devices. The recall was successfully completed with no reported patient injury and with minimal harm to our customer base.
The downside of not conducting a voluntary recall and waiting for an event that would force FDA involvement could have been a disaster from a patient safety, customer loyalty and regulatory enforcement standpoint.
Result(s): Recall was a success.
Outcome: Minimized financial impact. Preserved customer loyalty. Created a short inventory backlog.

>>>>>>>>>>>>>510(k) Premarket Notification<<<<<<<<<<<<<
Flexible Stenting Solutions' 510(k) Notification information is currently confidential.

>>>>>>>>>>>>>510(k) Premarket Notification<<<<<<<<<<<<<
Regulatory Body: US Dept. of Health and Human Services/ Food and Drug Administration
Event: Class II Device 510(k) Premarket Notification Submission for EP MedSystems, EP-WORKMATE
Device Classification Name: computer, diagnostic, programmable
Date(s): 11/26/1999 received by FDA – 03/23/2000 decision by FDA
Action(s): None – submission was complete
Result(s): determined to be substantially equivalent (SE) and cleared for marketing
Outcome: 510(k) No. K994011, Regulation No. 870.1425, Classification Product Code DQK
Comments: I prepared the complete submission and with my signature, took total responsibility for the truthfulness and accuracy of the submission. Device cleared in 117 days.

>>>>>>>>>>>>>510(k) Premarket Notification<<<<<<<<<<<<<
Regulatory Body: US Dept. of Health and Human Services/ Food and Drug Administration
Event: Class II Device 510(k) Premarket Notification Submission for ProCath® Locking Peel-Away Introducer Sets
Device Classification Name: introducer, catheter
Date(s): 04/19/1996 received by FDA – 05/13/1996 decision by FDA
Action(s): None – submission was complete
Result(s): determined to be substantially equivalent (SE) and cleared for marketing
Outcome: 510(k) No. K961513, Regulation No. 870.1340, Classification Product Code DYB
Comments: I prepared the complete submission and with my signature, took total responsibility for the truthfulness and accuracy of the submission. Device cleared in 24 days.

>>>>>>>>>>>>>510(k) Premarket Notification<<<<<<<<<<<<<
Regulatory Body: US Dept. of Health and Human Services/ Food and Drug Administration
Event: Class II Device 510(k) Premarket Notification Submission for ProCath® Electrophysiology Catheter
Device Classification Name: catheter, electrode recording, or probe, electrode recording
Date(s): 03/25/1999 received by FDA – 07/15/1999 decision by FDA
Result(s): determined to be substantially equivalent (SE) and cleared for marketing
Action(s): None – submission was complete
Outcome: 510(k) No. K991001, Regulation No. 870.1220, Classification Product Code DRF
Comments: I prepared the complete submission and with my signature, took total responsibility for the truthfulness and accuracy of the submission. Device cleared in 110 days.

>>>>>>>>>>>>>510(k) Premarket Notification<<<<<<<<<<<<<
Regulatory Body: US Dept. of Health and Human Services/ Food and Drug Administration
Event: Class II Device 510(k) Premarket Notification Submission for ProCath® Electrophysiology Catheter
Device Classification Name: catheter, electrode recording, or probe, electrode recording
Date(s): 11/19/1998 received by FDA – 02/22/1999 decision by FDA
Result(s): determined to be substantially equivalent (SE) and cleared for marketing
Action(s): None – submission was complete
Outcome: 510(k) No. K984150, Regulation No. 870.1220, Classification Product Code DRF
Comments: I prepared the complete submission and with my signature, took total responsibility for the truthfulness and accuracy of the submission. Device cleared in 93 days.

>>>>>>>>>>>>>510(k) Premarket Notification<<<<<<<<<<<<<
Regulatory Body: US Dept. of Health and Human Services/ Food and Drug Administration
Event: Class II Device 510(k) Premarket Notification Submission for ProCath® Pacing Threshold Cable
Device Classification Name: cable, transducer and electrode, patient, (including connector)
Date(s): 03/08/1994 received by FDA – 07/11/1994 decision by FDA
Result(s): determined to be substantially equivalent (SE) and cleared for marketing
Action(s): None – submission was complete
Outcome: 510(k) No. K941058, Regulation No.870.2900, Classification Product Code DSA
Comments: I prepared the complete submission and with my signature, took total responsibility for the truthfulness and accuracy of the submission. Device cleared in 123 days.

>>>>>>>>>>>>>510(k) Premarket Notification<<<<<<<<<<<<
Regulatory Body: US Dept. of Health and Human Services/ Food and Drug Administration
Event: Class II Device 510(k) Premarket Notification Submission for Dual-Thermistor Thermodilution Catheter & Infusion Catheter
Device Classification Name: catheter, flow directed
Date(s): 07/14/1987 received by FDA – 10/15/1987 decision by FDA
Result(s): determined to be substantially equivalent (SE) and cleared for marketing
Action(s): None – submission was complete
Outcome: 510(k) No. K872770, Regulation No. 870.1240, Classification Product Code DYG
Comments: I prepared the complete submission and with my signature, took total responsibility for the truthfulness and accuracy of the submission. Device cleared in 91 days.

>>>>>>>>>>>>>510(k) Premarket Notification<<<<<<<<<<<<<
Regulatory Body: US Dept. of Health and Human Services/ Food and Drug Administration
Event: Class II Device 510(k) Premarket Notification Submission for Balloon Thermodilution Pressure Transducer Catheter
Device Classification Name: transducer, pressure, catheter tip
Date(s): 02/11/1986 received by FDA – 05/02/1986 decision by FDA
Result(s): determined to be substantially equivalent (SE) and cleared for marketing
Action(s): None – submission was complete
Outcome: 510(k) No. K860526, Regulation No. 870.2870, Classification Product Code DXO
Comments: I prepared the complete submission and with my signature, took total responsibility for the truthfulness and accuracy of the submission. Device cleared in 81 days.

>>>>>>>>>>>>510(k) Premarket Notification<<<<<<<<<<<<<
Regulatory Body: US Dept. of Health and Human Services/ Food and Drug Administration
Event: Class II Device 510(k) Premarket Notification Submission for Arterial Embolectomy Catheter
Device Classification Name: catheter, embolectomy
Date(s): 08/29/1985 received by FDA – 01/15/1986 decision by FDA
Result(s): determined to be substantially equivalent (SE) and cleared for marketing
Action(s): None – submission was complete
Outcome: 510(k) No. K853625, Regulation No. 870.5150, Classification Product Code DXE
Comments: I prepared the complete submission and with my signature, took total responsibility for the truthfulness and accuracy of the submission. Device cleared in 136 days.

>>>>>>>>>>>>>510(k) Premarket Notification<<<<<<<<<<<<
Regulatory Body: US Dept. of Health and Human Services/ Food and Drug Administration
Event: Class II Device 510(k) Premarket Notification Submission for NOVA 12 Cardiac Output Computer
Device Classification Name: computer, diagnostic, pre-programmed, single-function
Date(s): 01/04/1984 received by FDA – 08/22/1984 decision by FDA
Result(s): determined to be substantially equivalent (SE) and cleared for marketing
Action(s): None – submission was complete upon submission of additional data
Outcome: 510(k) No. K840009, Regulation No. 870.1435, Classification Product Code DXG
Comments: I prepared the complete submission and with my signature, took total responsibility for the truthfulness and accuracy of the submission. Device cleared in 228 days.

>>>>>>>>>>>>>510(k) Premarket Notification<<<<<<<<<<<<
Regulatory Body: US Dept. of Health and Human Services/ Food and Drug Administration
Event: Class II Device 510(k) Premarket Notification Submission for Balloon Thermodilution Catheter
Device Classification Name: catheter, flow directed
Date(s): 04/20/1984 received by FDA – 08/12/1984 decision by FDA
Result(s): determined to be substantially equivalent (SE) and cleared for marketing
Action(s): None – submission was complete
Outcome: 510(k) No. K841639, Regulation No. 870.1240, Classification Product Code DYG
Comments: I prepared the complete submission and with my signature, took total responsibility for the truthfulness and accuracy of the submission. Device cleared in 112 days.

>>>>>>>>>>>>510(k) Premarket Notification<<<<<<<<<<<<<
Regulatory Body: US Dept. of Health and Human Services/ Food and Drug Administration
Event: Class II Device 510(k) Premarket Notification Submission for Balloon Thermodilution Infusion Catheter
Device Classification Name: catheter, flow directed
Date(s): 04/20/1984 received by FDA – 08/12/1984 decision by FDA
Result(s): determined to be substantially equivalent (SE) and cleared for marketing
Action(s): None – submission was complete
Outcome: 510(k) No. K841640, Regulation No. 870.1240, Classification Product Code DYG
Comments: I prepared the complete submission and with my signature, took total responsibility for the truthfulness and accuracy of the submission. Device cleared in 112 days.

>>>>>>>>>>>>>510(k) Premarket Notification<<<<<<<<<<<<<<
Regulatory Body: US Dept. of Health and Human Services/ Food and Drug Administration
Event: Class II Device 510(k) Premarket Notification Submission for Heparin Coated Balloon Thermodilution Catheter
Device Classification Name: catheter, flow directed
Date(s): 11/23/1983 received by FDA – 01/10/1984 decision by FDA
Result(s): determined to be substantially equivalent (SE) and cleared for marketing
Action(s): None – submission was complete
Outcome: 510(k) No. K834036, Regulation No. 870.1240, Classification Product Code DYG
Comments: I prepared the complete submission and with my signature, took total responsibility for the truthfulness and accuracy of the submission. Device cleared in 47 days.

>>>>>>>>>>>>510(k) Premarket Notification<<<<<<<<<<<<<
Regulatory Body: US Dept. of Health and Human Services/ Food and Drug Administration
Event: Class II Device 510(k) Premarket Notification Submission for Heparin Coated Balloon Thermodilution Infusion Catheter
Device Classification Name: catheter, flow directed
Date(s): 11/23/1983 received by FDA – 01/10/1984 decision by FDA
Result(s): determined to be substantially equivalent (SE) and cleared for marketing
Action(s): None – submission was complete
Outcome: 510(k) No. K834037, Regulation No. 870.1240, Classification Product Code DYG
Comments: I prepared the complete submission and with my signature, took total responsibility for the truthfulness and accuracy of the submission. Device cleared in 47 days.

>>>>>>>>>>>>>510(k) Premarket Notification<<<<<<<<<<<<<
Regulatory Body: US Dept. of Health and Human Services/ Food and Drug Administration
Event: Class II Device 510(k) Premarket Notification Submission for Balloon Thermodilution Infusion Catheter
Device Classification Name: catheter, flow directed
Date(s): 07/13/1983 received by FDA – 10/19/1983 decision by FDA
Result(s): determined to be substantially equivalent (SE) and cleared for marketing
Action(s): None – submission was complete
Outcome: 510(k) No. K832287, Regulation No. 870.1240, Classification Product Code DYG
Comments: I prepared the complete submission and with my signature, took total responsibility for the truthfulness and accuracy of the submission. Device cleared in 96 days.

>>>>>>>>>>>>>510(k) Premarket Notification<<<<<<<<<<<<<
Regulatory Body: US Dept. of Health and Human Services/ Food and Drug Administration
Event: Class II Device 510(k) Premarket Notification Submission for Balloon Wedge Pressure, Angiographic Catheter
Device Classification Name: catheter, flow directed
Date(s): 09/17/1982 received by FDA – 11/01/1982 decision by FDA
Result(s): determined to be substantially equivalent (SE) and cleared for marketing
Action(s): None – submission was complete
Outcome: 510(k) No. K822806, Regulation No. 870.1240, Classification Product Code DYG
Comments: I prepared the complete submission and with my signature, took total responsibility for the truthfulness and accuracy of the submission. Device cleared in 44 days.

>>>>>>>>>>>>>Importannt 510(k) Note<<<<<<<<<<<<
In addition to personally generating the engineering, design, test and manufacturing substance of all the above notification submissions, I prepared all device labeling and drafted all device instructions for use to comply with FDA requirements.

>>>>>>>>>>>>>Establishment Registrations<<<<<<<<<<<<<
Registered the following Establishments and the Official FDA Correspondent:
Flexible Stenting Solutions, Inc.
EP MedSystems, Inc.
ProCath, Inc.
Professional Catheter Corporation
Nova Medical Specialties, Inc.

>>>>>>>>>>>>>Device Listings<<<<<<<<<<<<<<
Listed all medical devices for the above Companies. Over 50 total listings.

>>>>>>>>>>>>>Medical Device Reporting (MDR)<<<<<<<<<<<<
Executed all MDR reporting for the most recent of the above Companies.

>>>>>>>>>>>>>Manufacturer and User Facility Device Experience (MAUDE)
Executed all MAUDE reporting for the most recent of the above Companies.

>>>>>>>>>>>>>Other Regulatory Licenses and Approvals<<<<<<<<<<<<<<
Obtained product Shonin (license) from the Japanese Ministry of Health for ProCath Pacing and Electrode type Catheters.

Obtained product Licenses from Health Canada, Therapeutic Products Directorate, Medical Devices Bureau for EP MedSystems Products.

Obtained many other small Country regulatory approvals for legal importation of our Products.

>>>>>>>>>>>>>Continuing Regulatory Education and Training<<<<<<<<<<<<<
Attended dozens of FDA, Industry (HIMA / AdvaMed) and Professional Society (RAPS, MDDI, AHA, ACC) sponsored seminars and round table discussions in GMP, GLP, cGMP, QSR, Medical Device Import / Export regulations, FDA Modernization ACT, etc.

>>>>>>>>>>>>>> Important Note<<<<<<<<<<<<<
This is not a complete list due to limited availability of searchable data on the internet using conventional search engines. Additionally, ownership of some medical device regulatory related documentation containing original Company name and my name as preparer, submitter or official, may have changed hands or has been “redacted” by the regulatory agency. With respect to employer’s property, I have not retained personal copies of regulatory/ quality documentation, applications, registrations or listings generated by me and the approvals I obtained during my career. Therefore, I arranged this list with my best recollection of the past 25 years. Most searchable databases do not go back that far.