Christopher Hack

csh headshot 2012


Mr. Hack is the founder of Hack & Associates.   He concentrates his practice in medical device valuation, strategic product positioning, regulatory pathway consulting, and risk management.

Mr. Hack has over10 years of FDA regulatory experience and has successfully sought approval for a wide variety of medical devices.  Mr. Hack has brought to market numerous applications and has considerable experience with implantable orthopedic devices, combination products, and humanitarian use devices.  Mr. Hack has experience with product and patient labeling, designing post-approval studies, and preparing risk mitigation and evaluation strategies.

Mr. Hack has negotiated approvals for a wide range of medical device technologies including mobile bearing joint replacements, spinal disc replacements, wound dressings with active drug and biologic agents, sutures, pumps, stents, diagnostic tools, bone morphogenic proteins (BMPs), hip implants, and shoulder implants.   He has also negotiated licenses and other agreements involving clinical trials and intellectual property.

Prior to founding Hack & Associates, Mr. Hack worked as a  reviewer at the Food and Drug Administration, Center for Devices and Radiological Health (CDRH) in the Office Of Device Evaluation (ODE) where he reviewed numerous pre-market applications such as PMAs, 510(k)s, IDEs, and HDEs  for class III medical devices including joint and spinal devices.  While at the FDA, Mr. Hack helped to draft various internal and external FDA guidance documents and reclassification petitions.

Mr. Hack also worked as a patent examiner for the United States Patent and Trademark Office.  There he worked on implantable electrical stimulation devices such as pacemakers, neuro-stimulators, and muscle stimulators.

Mr. Hack also served as in-house counsel and Regulatory Manager for a small biotech company, where he provided legal analysis pertaining to FDA Regulatory matters including combination products, package insert drafting, packaging and labeling.  He has also conducted contract negotiations.

Mr. Hack received his Bachelor in Science in Bioengineering from the University of Pennsylvania and his Juris Doctor from the University of Maryland School of Law.

Mr. Hack is admitted to practice in Maryland and in the District of Columbia.