When Regulatory Goes Wrong

By Bob Marshall, Chief Editor, Med Device Online

In spite of my preference for “happily ever-after” as detailed in a previous article, sometimes things do not go well for medical device companies as it pertains to regulatory affairs. If I have given attention to times when things turned out well, it’s only fair to talk about some situations where things got a little, shall we say – “out of hand.” Note: no names are used in these anecdotes, and some details may have been generalized to protect the identities of the companies involved.

Know Thyself, And Thine Own Device

A small technology company designed and developed a personal protective alarm system that one could use to contact family or emergency services when in need. The company mistakenly believed the product was not a medical device, as it provided no specific medical information. After several years on the market in the United States, the company wanted to expand globally and sought the assistance of a consultant to prepare its quality management system for ISO-9001 certification.

The consultant, who also was experienced with medical device quality systems and requirements, informed the company its product was, in fact, considered a Class II medical device by the FDA (510k exempt). The company scrambled to quickly build a lean Quality Management System and established record-keeping procedures to become compliant. Going through this process caused the organization to consider if it really wanted to be in the medical device business.

Ultimately, the company realized the alarm device was not a key part of its product portfolio, and they decided to phase it out to avoid the additional cost and overhead of marketing a medical device. This company was very fortunate the FDA did not become aware of it earlier and perform an inspection. Doing so likely would have shut down the business.

Stick To The Script…And Labeling

A medical professional affiliated with a startup incubator developed a superior dental implant device. The staff at the incubator explored potential strategic pathways and regulatory positioning for the new implant device. They determined the device could be Class II (510k required) with limited claims, or Class III (PMA required), given the actual capability and performance of the implant.

Obviously, these two potential pathways involve differing amounts of time and cost, primarily because the Class III pathway would require clinical trials. Ultimately, the incubator staff chose the shorter, less-burdensome path as a Class II device with limited claims and no clinical trials. A face-to-face pre-submission meeting was scheduled with the FDA to seek guidance, and hopefully concurrence, on the anticipated regulatory pathway.

During the pre-submission meeting, the medical professional and the FDA medical specialist had a side-bar discussion on what the device was “really” capable of doing. In the discussion, the medical professional admitted the implant device had additional capability and boasted to his “colleague” of the performance he had seen in experiments which would make the device fit into Class III. After the full pre-submission meeting resumed, the discussion turned to the true capabilities of the implant device and, at the conclusion of the pre-submission meeting, the FDA indicated it would not accept a 510k, and would instead expect a PMA with full clinical data for the implant device.

The dental device never made it to market, as no investors stepped forward willing to fund the clinical trials and PMA for the device. This was partially due to the company previously seeking investment for the device stating it would not need clinical trials. The change to a full PMA with clinical data made potential investors lose confidence in the development team, as well as question their understanding of the market they would be entering.

Do You Really Want To Change The World?

A startup company developed a revolutionary diagnostic device to predict patient instability in advance of existing diagnostic monitoring methods. The device would be able to indicate whether a patient was likely to go into shock or have a traumatic episode, well in advance of the actual onset of the event. This would provide more time for medical professionals to take action to prevent these events, which often escalate out of control and can result in the loss of life.

The company developed a prototype device and did some early non-invasive testing to establish effectiveness. In those test, the results were highly accurate and compelling. A regulatory pathway was identified whereby the device would be used as an adjunct monitoring tool to provide additional information to the medical professional. In this capacity, the new device could fit into an existing Class II designation. A pre-submission meeting was scheduled with the FDA to confirm the classification as a Class II device with a 510(k) regulatory pathway.

Unfortunately, during the pre-submission meeting, the inventor of the technology told the FDA his invention was going to “change the standard of care” in all medical applications and traditional monitoring would become obsolete. This caused the FDA personnel in the pre-submission meeting to view the new device as a standalone novel diagnostic system which would require a PMA with full clinical trial data for safety and effectiveness. The startup company was able to recover by proposing significant limitations to device claims and clearly labeling the device for use only in conjunction with existing diagnostic monitoring practices and did ultimately achieve 510k clearance. The device, however, struggled to achieve acceptance in the market due to these limiting conditions, and may never achieve its full life-saving potential.

Getting Regulatory Right The First Time

To avoid regulatory wrongs and provide the best opportunity for “happily ever after”, begin with a solid regulatory strategy by answering these questions:

• Is the product to be developed really a medical device according the FDA?
• What is the intended use of the device?
• What is the environment of use? (e.g., hospital, doctor’s office, home, mobile)
• What medical specialty does the device fit into? (i.e., 21CFR Parts 862-892)
• Is there an applicable regulation number? (e.g., 21CFR 864.5220)
• What is the product code? (e.g., GKZ)
• What is the classification of the device? (Class I, II, or III)
• What are the submission requirements? (none, 510k, PMA)
• Are similar products available on the market? (predicate device)
• Are there applicable Standards or Guidance Documents?