On July 21-22, the American Conference Institute (ACI) held its Fourth Annual FDA Boot Camp: Medical Devices Edition in Chicago, Illinois. The conference provided both basic and advanced training in core regulatory concepts for medical devices.  McGuireWoods LLP’s Brian Malkin presented on “High-Risk Devices – Parsing the Premarket Approval Process (PMA)” and “Quality System Regulation”.

Special to the Conference was a Keynote by Robin W. Newman, MSN, Ed.D., Director, Office of Compliance, Center for Devices and Radiological Health (CDRH), FDA. Newman joined CDRH in February 2016 following a 20-plus years in senior level clinical/regulatory and management in new product and research, most recently as Vice President of Quality Management for Siemens Healthcare Diagnostics.

Newman focused her Keynote on a new draft FDA Guidance: “Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions”, issued on June 16, 2016.  Newman provided an impassioned vision where FDA’s goal is not to catch companies being out of compliance; rather, FDA’s goal is to help move companies into quality by meeting the needs of their users.  Newman explained that with her background as a nurse practitioner, she embraced the vision for companies to take their focus for product development and quality to the patients.  FDA is taking this to heart by setting goals that by December 31, 2016, 50% of CDRH employees will have interacted with patients as part of their job duties, and by December 31, 2017, 90% of CDRH employees will have met these goals.

Newman emphasized, “Patients are our most important customer.” She explained that FDA started its campaign to focus back on patients in 2014 with a draft guidance for a shared framework.  In her opinion, compliance is the “easy part,” whereas considering patient benefits in the decision-making process may be “something new.”  CDRH is working with the Office of Regulatory Affairs (ORA) to share the framework for risk to reach a better understanding more quickly and consistently to assure a level playing field across medical device firms and reduce the public’s duration to risk.  FDA contemplates this will be a two-year process, including draft to final publication time to implement, and already has involved a variety of stakeholders, such as the Association for the Advancement of Medical Instrumentation (AAMI), and over 60 industry representatives, who helped in a subgroup to put together the draft guidance.

Key points from the Draft Guidance:

  • Complements the premarket benefit-risk guidance document
  • Includes product availability and compliance and enforcement decision
  • Balances FDA authority v. patient benefit
  • Describes benefit-risk factors
  • Provides examples and worksheets.

Newman said the goal is not to generate more warning letters; the goal is to get companies into compliance and to figure out the best path to get there. When considering benefits, Newman said that FDA will look to the impact on patient health: Is the product more “mistake proof”?  Is it a life changing / saving technology?  Is there a high magnitude of benefit?  Is it critical to a certain subpopulation?  What is its duration of effect?  What do patients prefer (and can they make those assessments, e.g., can patients make the choice which pacemaker is better)?  Broadly, in terms of risk, FDA looks to the overall health impact: Are there false positives or negatives for tests and what are the consequences of each?  What are patient tolerances of risk?

Newman said the vision for compliance objectives would be an agreement with companies to make commitments in certain timelines for certain enforcement discretion if those timelines are met. FDA is looking for both active and proactive postmarket surveillance in case there are changes noted in the risk profile for a device.  For example, if a product has low risk and high benefit, FDA will work with a company to keep the product on the market; if high risk and low benefit, FDA is more likely to be more aggressive with compliance actions and requirements.  FDA also wants companies to evaluate risk as part of the life cycle of the product.  Comments on the Draft Guidance are due September 14, 2016.

When asked about how CDRH works with ORA, Newman described it as a partnership with a complex interconnection between what happens at the district versus headquarters. In response to a question about how FDA expects physicians to communicate choices in products to patients, where many decisions appear to be made by physicians on their own (or because physicians perceive that patients want their physicians to make those decisions themselves), Newman said that groups such as the Medical Device Innovation Consortium (MDIC), patient groups, providers, and others should seek to get the patient voice, where appropriate and possible.

The conference also featured advanced special topics, such as off-label uses and enforcement (including the latest decisions ofVascular Solutions and Facteau and Fabian), digital health, refurbished and reused devices, unique device identification, medical device reporting, recalls and withdrawals, and overall labeling and promotion.