Tell Me, Tell Me, Where I’m Going: Recent FDA Presentation Offers a Crystal Ball Into Medical Device Inspectional Priorities and Compliance Activities

Our law firm recently hosted a program where local Food and Drug Administration district representatives discussed agency inspections of medical device companies. The information presented was a compilation of information from FDA’s website. We thought the presentation was a good summary, as were the agency recommendations to respond to FDA enforcement actions.

In this Bulletin, we highlight some of these findings, which provide a glimpse into FDA’s priority concerns and should help companies proactively and properly plan for their next inspections. To paraphrase from the rock band Styx’s song, “Crystal Ball,” FDA is telling device companies where it is going.

Inspections and Actions

  • There are more than 7225 medical device manufacturers registered with FDA in the United States

    • 5% are Class III manufacturers
    • 45% are Class II manufacturers
    • 50% are Class I manufacturers
  • In FY ’15, there were 1174 medical device recalls

    • 5% were Class I recalls, the most significant type of corrective action due to potential safety concerns
    • 91% were Class II recalls
    • 4% were Class III recalls
  • FDA device inspections decreased a little in FY ’14 from FY ’13 – – 3278 from 3638. In FY ’12, the agency conducted 3511 device inspections (the FDA presentation did not break down domestic versus foreign inspections, but the aforementioned address is useful for such information)
  • In FY ’14, of these 3278 inspections

    • 6% were classified by FDA as OAI, or Official Action Indicated, where the agency concluded it needed to take some type of enforcement action
    • 35% were classified as VAI, or Voluntary Action Indicated, where the company promised to take some type of corrective action to address deficiencies
    • 59% were classified as NAI, or No Action Indicated

FD-483 and Warning Letter Observations

  • In FY ’14, FDA issued 972 FD-483s (a list of inspectional observations to medical device firms of deficiencies to fix)

    • in contrast, the agency issued 1099 FD-483s in FY ’13, 1090 in FY ’12, 1035 in FY ’11, and 976 in FY ‘10
    • common FD-483 observations issued to device companies were:

      1. lack of or inadequate procedures, e.g., procedures for corrective and preventive actions (CAPAs) have not been adequately established (21 C.F.R. § 820.100(a))
      2. lack of or inadequate complaint procedures, e.g., procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established (21 C.F.R. § 820.198(a))
      3. lack of or inadequate procedures relating to quality audits, e.g., quality audits have not been conducted (21 C.F.R. § 820.22)

  • Other common FD-483 citations included: lack of or inadequate procedures relating to purchasing controls, lack of or inadequate process validation, lack of written Medical Device Reporting procedures, inadequate documentation, lack of or inadequate procedures for design changes, and lack of or inadequate non-informing product
  • In FY ’14, FDA issued 108 Warning Letters to device companies

    • lack of or inadequate procedures relating to CAPAs, process validation, and purchasing controls were common deficiencies cited in the Warning Letters
  • FDA reiterated that it will generally allow companies to respond to FD-483 observations within 15 business days of receipt before deciding on any next steps
  • If a company does not respond within 15 business days, the agency reserves the right to proceed with a Warning Letter without reviewing the adequacy of the company’s proposed corrective actions described in the FD-483 response

Some FDA Recommendations for an Adequate Response

  • Show executive management’s commitment to address the inspectional observations, such as improved management oversight of corrective actions
  • Spend appropriate resources to make the necessary corrections, such as capital improvements and hiring or retraining personnel
  • Include a roadmap to reach compliance, such as a timeframe when corrective actions will be completed, evidence of remedial actions and, where appropriate, updating FDA on progress
  • Provide an index for attachments for a large response
  • Include a chart identifying open and closed/resolved commitments if there are multiple responses

AGG Observations

  • Much of what FDA presented was not new, but it does reflect that, to some extent, many in the device industry continue to make the same mistakes – – the common FD-483 and Warning Letter citations do not change significantly from year-to-year
  • The presentation, and information provided on FDA’s website, offer FDA’s playbook into enforcement trends; it does not require a crystal ball to avoid becoming an enforcement statistic
  • Companies should review and re-review internal quality-related procedures and processes to ensure regulatory compliance, keeping FDA’s written concerns in mind
  • Proactive planning and upfront expenditures can potentially minimize, even if not eliminate, enforcement risk; responding retroactively, through corrective actions, will likely take more time and money, which will result in all types of negative consequences, including lost product sales and financial disruption
  • FDA wants companies to comply with quality standards voluntarily, as evidenced by its preference for VAIs over OAIs; our experience is that FDA is not looking for a fight or to punish a company, but its job is to protect the public health
  • Doing things right in the beginning and, if needed, responding effectively if deficiencies occur, will demonstrate to the agency that a company has its house in order