FDA Program Alignment & The New CDRH in Bite-Sized Chunks

Changes at the FDA are impacting life science manufacturers.  In 2013 the Agency initiated an effort to realign its programs, streamline and restructure the organization so that it could keep up with new advances in science, product complexities, and globalization.  The FDA’s Program Alignment Group introduced a set of changes that would restructure the agency and its divisions. Many of these modifications have been implemented this year and additional adjustments are expected in 2017.

• No More District Offices. FDA will have three global offices and there will no longer be 20 district offices.
• Inspection Assignments. Inspections will be assigned by the FDA Centers instead of district offices.
• Investigators Assigned by Expertise; Expect Multiple Visits Annually. Currently, the FDA is organized by geographic regions.  Soon, the Agency will reorganize districts and group investigators by area of commodity-based (i.e., medical device, pharmaceutical, etc.) expertise.  Therefore, your FDA district directors may change.  Life science manufacturers with diverse or combination products can also expect annual visits from multiple investigators with varied expertise.
• Shift Towards Risk-Based Enforcement. In the past, manufacturers have expected regularly scheduled FDA inspections about every two years.  Due to FDA’s shift towards risk-based enforcement, manufacturers who are not deemed “high-risk” may have less frequent inspections.  FDA utilizes a non-public algorithm to determine high-risk companies. This realignment does not mean that lower risk manufacturers are “in the clear” as FDA will continue to correspond with all manufacturers using electronic communications.  To ensure successful inspections, manufacturers are encouraged to be responsive to FDA requests, enhance the line of communication, and stay updated with changes.  This move toward risk-based enforcement allows FDA to apply its resources where it is most needed (e.g., foreign locations).
• FDA to Adopt NIPP in 2017. The FDA’s New Inspection Protocols Project (NIPP), which will be adopted in 2017, was developed to streamline and harmonize the inspection process. The agency plans to use a more digital (i.e., tablets), semi-quantitative approach to drug quality surveillance and inspection.  The information garnered during inspections can be viewed by the Center in real time, and NIPP will help the FDA make more informed decisions on frequency and prioritization of inspections.  Currently, the Office of Pharmaceutical Quality (OPQ) has adopted NIPP.  It is not clear if other Centers within the Agency will follow suit.
• FDA Quality Management System. By mid-2018, the FDA will establish its own Quality Management System to become eligible for ISO 9001 certification.
• Large Number of Investigators Retiring. Many experienced FDA investigators have or will soon retire.  As a result, a majority of investigators will have less than five years of experience.
• Strengthen MDSAP. Efforts will be made by the International Medical Device Regulators Forum to strengthen MDSAP (Medical Device Single Audit Program). The MDSAP was created to internationally harmonize the inspection and auditing of medical device manufacturers in a single audit.  The U.S., Brazil, Canada, Australia, and Japan will accept MDSAP.  This is a significant benefit to U.S. manufacturers as the FDA will accept the MDSAP audit reports in lieu of routine Level 1 and 2 inspections and it will potentially decrease the number of inspections for manufacturers.  Canada will transition to use MDSAP in place of its own inspection program. All manufacturers who sell devices in Canada must transition from CMDCAS to MDSAP certificates to meet the quality management system requirements.  Canadian medical device licenses not supported by a valid MDSAP certificate as of January 1, 2019, will be subject to suspension.  For more information, visit the Health Canada website at Health Canada – MDSAP FAQs
• CDRH Top Priorities and Goals.  Robin Newman, MSN, EdD, is the new Director, Office of Compliance, Center for Devices and Radiological Health (CDRH), and she will be leading the charge to reach the CDRH’s strategic priorities and objectives.  The division will transition from its current focus on compliance to one that emphasizes patient safety and product quality.  Its top priorities and goals include:
  • Partnering with Patients – CDRH’s goal is to interact and partner with patients to advance the development and evaluation of innovative devices, while also monitoring the performance of marketed devices.  CDRH has already exceeded its 2016 goal to have 50% of its employees interact with patients.  Currently, 75% of CDRH employees have patient interactions.  To promote a culture of meaningful patient engagement, 90% of CDRH employees will interact with patients by December 2017.
  • Quality in the Office – CDRH’s initial goal was to increase the number of staff with quality and process improvement credentials by 10%, but the office has surpassed this goal by achieving a 20% increase.
  • The Case for Quality – According to a 2010 FDA study, for many years there has been a high number of inspections with “Official Action Indicated” (OAI) outcomes that recur year after year (i.e., Production and Process Controls, Design Control, CAPA, and Risk Management).  As a result, one of the goals of Case for Quality is to identify new metrics and measures to see how device quality is measured, monitored, and controlled. CDRH has developed metrics, successful industry practices, standards, and tools that manufacturers can use to evaluate product and manufacturing quality beyond compliance with regulatory requirements.  CDRH plans to pilot voluntary use of product manufacturing quality metrics by December 31, 2016, and by December 2017 CDRH will have proposed a voluntary program to recognize independent evaluation of product and manufacturing quality.
  • Quality in the Ecosystem: Critical to Quality (CtQ) – The CDRH drafted the CtQ guidance documents and asked investigators and manufacturers to provide their insights. Feedback from the two groups included:
    • Investigators: Reported that the inspection process itself became more efficient, and, as a result, the investigators have more confidence in the inspection process.
    • Manufacturers: Stated that because they are aware of CtQs before an inspection and know what areas are likely to be inspected, they can prepare for an inspection. This potentially improves process and product quality before an inspection even occurs. Overall, CtQ is a useful tool because it has more elements that would be inspected than QSIT.

Impact of Benefit-Risk Compliance Enforcement on Patients  – FDA released a new draft guidance detailing its approach to considering the benefits and risks for compliance and enforcement actions that could impact medical device availability.