Practice Areas

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 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.

Labeling and Advertising

KKB has expertise in all aspects of medical device labeling. We advise on the proper wording, formatting, submission and/or approval of labels, labeling (such as detail pieces), advertising and other promotional materials (including social media and internet promotion).

Research and Approval

KKB’s advice covers all aspects of medical device research and approval, including:

  • Licensing and related issues for:
    • Investigational Device Exemptions (IDEs)
    • 510(k) Premarket Notifications
    • Premarket Approval Applications (PMAs)
  • Compliance with post-approval requirements for changes in products, labeling and manufacturing processes
  • Interpretation and application of FDA Quality System requirements
  • Establishment registration and product listing
  • User fees
  • FDA reporting requirements

Enforcement

KKB handles a wide range of medical device-related enforcement activities by FDA and other federal and state regulatory agencies. These include

  • FDA enforcement proceedings, including the conduct of inspections, responses to inspectional observations, Warning Letters, section 305 hearings, negotiation of consent decrees and litigation
  • FDA-related import and export issues
  • Assistance with recalls

Contracts, business planning and due diligence

KKB assists clients in drafting agreements relating to regulatory issues, such as guarantees, labeling agreements (for exemption from labeling requirements for devices to be further manufactured), agreements for clinical studies, etc. We assist business planners in evaluating the investment needed to support new products, ingredients and claims. We also conduct due diligence reviews of medical device companies and products that are being considered for acquisition.