MEDICAL DEVICES

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 advise on issues relating to:

		Investigation of medical devices (IDE, IRB, informed consent)
		Premarket clearance (510(k) and PMA) and related user fees
		Manufacturing (GMP/QSR)
		Recalls
		Recordkeeping and reports (MDR and post-market surveillance)
		FDA dispute resolution procedures
		Quality System Requirements

We handle litigation involving devices, including seizures, injunctions and consent decrees. 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.

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.