KKB represents medical device companies and associations in helping to assure compliance with applicable regulatory requirements, including whether a product is a device rather than a drug or biologic and whether a product is subject to regulation as a device at all. We have experience with a wide range of devices from the most simple (condoms, medical gloves) to the most complex (cardiac pacemakers, implantable defibrillators, heart valves, and cochlear implants) and including products that may be considered a combination of a device and a drug or a biologic or a cosmetic.

KKB assists clients in developing and implementing healthcare compliance programs in accordance with the OIG Compliance Program Guidance for Pharmaceutical Manufacturers, the PhRMA Code on Interactions with Healthcare Professionals, the AdvaMed Code of Ethics on Interactions with Health Care Professionals, and related state laws, such as California's S.B. 1765 (2004). KKB drafts key documents for clients, including detailed policies and procedures, needed to support a client's compliance program and will conduct training of affected employees. KKB monitors enforcement trends and helps clients keep compliance programs up to date.

The firm has also been actively involved in efforts to streamline regulatory requirements, including efforts leading to expedited 510(k) and PMA clearance, reclassification, novel approaches to GMP/QSR and pre-approval inspections, and assisting in the development of guidance documents.