This certified Regulatory Affairs Professional has more than 20 years of experience ensuring compliance with the FDA. Throughout his career, he has managed 510(k) submissions, reviews, appeals, and clinical trials for a multitude of devices with applications ranging from dentistry to cardiology and neurology. Prior to launching his current consultancy, he served as a Director of Regulatory Affairs at medical device firms that manufacture class II and class III products. Have experience with:
Catheters/Stents: IV administration sets, peripheral perfusion/infusion catheters, coronary perfusion/infusion catheters, thoracic catheters, chest drains and blood bags, embolectomy catheters, thrombus aspiration catheters, PTA, PTCA, CVC, ECMO, retrograde and antegrade hemodialysis catheters, urethral and ureteral catheters/stents, insulin administration, Closed System drug Transfer Devices (CSTD), non-roller cardiopulmonary bypass pumps and catheters, coronary and peripheral BMS, peripheral covered stents, aortic covered stents, DES, ureteral stents, urological stents, esophageal stents, intracranial aneurysm stents, pericardium covered stents, vascular grafts and vascular grafts with helix or nitinol reinforcement, and vascular patches.
Biomaterials: bone void fillers, resorbable implants, hydroxyl appetite, hyaluronic acid, dental impression materials, PEEK, calcium carbonate, Beta TCP, imaging contrast agents, hydrogel dressings, lubricious coatings, artificial saliva, contact lenses and contact lens solutions, antimicrobial coatings, antithrombotic coatings, IIb/IIIa inhibitors, mTOR inhibitors, and omega3 coatings, injectors and pens, antimicrobial wound cleanser and bandages.
Orthopedic/Dental: ACL/PCL screws, suture anchors, tacks, staples, spinal cages, trauma plates and screws, CMF, approximation pins and rods, dentures, veneers, dental implants/abutments, impression material, autoclave equipment, dental units, limb lengthening systems, and intra-oral x-ray equipment.
Accessories: tunnelers, suture wings, convenience kits, stylets, peel away dilators, cannulas, scalpels, suture, guidewires, sheathes, extension sets, repair kits, luer valves, needle/syringes, blood vacuum tubes, needle safe devices, O2 regulators, radiation therapy patient positioning systems, radiation range compensators, sterilization biological and chemical indicators, and fiber wire docking stations.
Hardware/Software: neonatal clinical trial software, firmware, RIS software, image repository software, ECG analyses software, TENS, MIRS, MMA, MDDS, EMC therapy, PACS, stereotactic tracking system, stereotactic software, patient monitors, ventilators, lift beds, TMS (transcranial magnetic stimulator), active tinnitus implants, Holter monitors, phototherapy devices, data fusion software, hyperbaric chambers, autoclave sterilizers, powered muscle stimulators, cryosurgical units, MDM workflow software, Doppler and GPS ultrasound scanners, GPS needle sensors, vascular access needles, RF, nerve block needles, fiber optical lasers, neuron stimulators, and therapeutic massagers, MIMS, viewing monitors, body contouring devices.
Reusables: nasopharyngoscope, colonoscope, colposcope, neurological endoscope, sinuscope, arthroscope, and laparoscopes, instruments, tunneler rods, irrigation systems, therapeutic mattresses, OB/GYN scopes, patient cables and electrodes, scooters, vein graft tunneling systems, confocal optical imaging devices, and cannulae, 3DHD endoscopes, IR fluorescence and Indocyanine green endoscopes, measuring microscopes.
General Surgery: surgical film, pressure mattresses, cryo-biopsy needle, surgical mesh, plugs, anal fissure drug suppository and delivery plunger, anorectic Nifedipine CTD, red light therapy dermatology lasers, surgical lasers, and Continuous Low Irradiance Photodynamic Therapy (CLIPT) for phototherapy drug activation, collection and transport media, disinfecting swabs and wipes, gastrostomy tubes.
Past positions have been RA/Clinical and RA/QA at various levels including the roles of specialist, director, client manager, project manager, third party, expert witness, and consultant.
Previous lead regulatory person on device and combination product and clinical submissions including 510(k), 515i, Pre-IND, IND, Pre-IDE, IDE, HUD, PMA, Pre-Sub, Recall, Correction, CE, and OUS registrations.
Legal experience includes testifying in litigation, product liability, infringement, expert witness testimony, and deposition.
Recent clearance/approvals include 510(k) (K060288, K073092, K073093, K090182, K090190, K090709, K093431, K100595, K100076, K101401, K101839, K102596, K103346, K110110, K110282, K110793, K110794, K111226, K111595, K113112, K120552, K120875, K121812, K123943, K130424, K131045, K131144, K131323, K131557, K131814, K132899, K133222, K141002,P140003, K150219, K150454, K151937, K152204, K152636, K152819, K153256, K153548, K153699, K160472, K160475, K160686, K160688, K160977, K161062, K161734, K161743, K161931, K162011, K162862); IND (105563, 108372); IDE (G110180,G110194, G120159), HC CTA (149462, 149988), USAN (xx-130/9459), and HUD ( 09-0213).
Other recent submissions include MAF (MAF-1624, MAF-1677), Pre-sub/Pre-IDE (Q120079, Q120188, Q131525, Q140005, Q140006, Q140629, Q141168, Q160673, Q161482, I070775, I090555, I090626, I100414, I100771, I100795, I110249, I110270, I110442, I110287, I110664, I110766, I111060, I120752, I184916), 515i (K063723, K083111), De Novo (K090423), Recall Correction (Z-0115-2014), and Appeal (K100771).
Recent submission experience includes CE (TUV Rhineland, TUV SUD, Intertek, SGS, DGM, NSAI, SNCH, BSI, UL), medicinal consultations (MHRA, MPA, ETAT), license applications (India, Canada, Australia), and OUS registrations (Latin America, Asia, and Eastern Europe).
Participated in numerous meetings, depositions, expert witness testimony, and conference calls with FDA, notified bodies, legal counsel, competent authorities (Health Canada, TGA, SFDA, COFEPRIS, and MHFW), and attend meetings in Silver Spring, MD.