R. P.Chiacchierini & Associates, LLC

Statistical and Regulatory Consulting

R.P. Chiacchierini & Associates

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Principals:
Richard P. Chiacchierini
Richard E. Lippman

Services:
Biostatistical Services
Device Regulatory Affairs
Quality Systems & Compliance
Biologics Regulatory Affairs

Richard E. Lippman, OD, FAAO

VP Ophthalmic Product Regulatory Affairs

Richard E. Lippman

Dr. Lippman’s specialty is ophthalmic devices, and he has worked extensively with IOLs, contact lenses, ophthalmic lasers, refractive surgery devices, glaucoma shunts, lens solutions, disinfection units and other diagnostic products. He assists medical device manufacturers with regulatory strategies and submissions, including IDEs, 510(k)s and PMAs. Dr. Lippman spent eight years as a successful consultant with C. L. McIntosh & Associates before joining R. P. Chiacchierini & Associates. Dr. Lippman can be reached by e-mail at rel@rpcaconsulting.com.

In addition to his consulting experience, Dr. Lippman has many years of senior management experience with FDA’s Division of Ophthalmic Devices, Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH). From 1986 to 1993, as Director of this Division, he was responsible for managing the review of 510(k)s, IDEs, PMAs, and reclassification petitions for ophthalmic devices. This included developing strategic approaches to device review, designing and implementing policy on new products, and managing the related Advisory Panel.

From 1984 to 1986, he was the Chief of the Contact Lens Branch in the same Division. Prior to that, he served as a Clinical Medical Officer.

Before joining the FDA, Dr. Lippman was Chief Optometrist at the US Public Health Service Hospital, Staten Island, New York from 1974 to 1983.

Dr. Lippman earned a BA (biological sciences) at the University of Vermont and BS and OD degrees from the New England College of Optometry. He has been awarded fellowship in the American Academy of Optometry. Dr. Lippman was appointed as Chief Optometry Officer of the Commissioned Corps of the U.S. Public Health Service, by Surgeon General Antonia Novello in 1990. In addition, Dr. Lippman is a practicing optometrist.