Tips and pointers offered for FDA medical device regulation

by Cydney Boler, JD, MPH

Many medical professionals are keenly interested in the research and development of new and improved medical devices. Orthopedic surgeons, in particular, are inventive professionals, with ideas for new instruments and devices that might be useful in their profession. Understanding the basic regulatory landscape — and knowing what regulatory questions to ask — creates an important competitive advantage and may increase clinical research revenue. Understanding in advance how to avoid costly pitfalls in bringing a new device to market is crucial to success. Research sponsors recognize this well, and often prefer principal investigators who demonstrate they are up-to-date on the ever-changing regulations.

What is a medical device?

Whether you are a clinician, principal investigator, or sponsor, understanding what the FDA considers a “medical device” is the first step in determining the proper regulatory path and the basic questions to ask. The definition of medical device is found in 21 CFR 201(h), which establishes a four-prong test for determining whether something is or is not a medical device:

• Does the device diagnose, cure, mitigate, treat, or prevent a disease or condition?
• Does the device affect the structure or function of the body?
• Does the device achieve its intended use without chemical action?
• Does the device achieve its intended effect without being metabolized?

If the answer to all four questions is yes, then the device will be regulated under rules associated with medical devices and subject to those regulatory requirements. Answering no to one or more does not mean that the device is exempt from FDA regulation: it simply means this may not be a “medical device” as defined by the statute.

FDA classifications of medical devices

Lawrence H. Brenner

B. Sonny Bal

The FDA has three classifications for medical devices: Class I, II and III. Which classification applies impacts what regulatory controls are placed on the device. Prior to using, testing, or marketing a medical device, the manufacturer and/or distributor of the device must carefully determine the appropriate classification of the device, and comply with whatever restrictions are imposed. Properly classifying the device is of key importance. If you misclassify a device, you could be failing to comply with the correct regulatory scheme, which in turn can result in fines, and even possible jail time. It is therefore essential to chart a safe path through the dangerous regulatory waters, and work with knowledgeable advisors and experienced counsel to lower your risks.

Class I

Class I devices are considered low-risk devices and are typically exempt from premarket submissions to the FDA. Devices typical of this classification are crutches, most bandages, compression shorts, ankle braces, and tongue depressors. Class I devices are subject only to general controls. Devices subject only to general controls have minimal requirements compared to requirements for other classes. General-controls requirements include registration of the manufacturer with the FDA; good manufacturing techniques — not to be confused with good manufacturing practices, or GMP; proper branding and labeling; notification to the FDA before marketing the device; and compliance with general reporting procedures.

Although generally Class I devices are exempt from the requirement to use good manufacturing practices and the FDA notification regulations, there are exceptions. Depending on the stated/purported use of a device, it may be necessary to obtain a premarket approval — often casually referred to as a 510K — for a device which is otherwise classifiable as a Class I device. Such devices must meet additional controls providing reasonable assurance of safety and effectiveness, and are referred to as “reserved devices.”

Class II

Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness. Examples of Class II devices are tampons, wheelchairs, and needles. They are subject to special controls in addition to the general controls of Class I devices, including special labeling requirements, mandatory performance standards, use of good manufacturing practices, premarket notification requirements (except as explained below), and post-market surveillance.

The FDA has also published a list of Class II devices which are, subject to certain limitations, exempt from premarket notification requirements. The FDA believes that relieving manufacturers from the need to submit premarket notification for these devices will enable the agency to redirect resources that it would otherwise spend on reviewing such submissions to more significant public-health issues. However, note that this list does not exempt the manufacturers from the requirement to use good manufacturing practices.

Class III

Class III devices are considered to pose the highest risk if something goes awry. Common examples include heart valves, gastric bands, and pacemakers. These devices are life-sustaining devices, and require premarket approval supported with clinical data. Class III devices must meet a rigorous premarketing approval standard, which can easily delay the release of the product by months, or even years. For these devices, sufficient preclinical animal data, as well as controlled clinical trials, are often required. Protection of human participants is paramount, and follow-up postmarket approvals are often required. This is all labor intensive: According to the FDA, nearly 1,200 hours are spent, on average, in the regulatory submission process between the sponsor and FDA reviewer assigned to review the application.

Medical device approval

In the research and academic world, we are most used to dealing with Class III devices. Time is always working against the clinician, principal investigator, and sponsor. A typical exclusive market-life for a new medical device is only 18 months before competitors being selling alternatives. Add to this an often-short useful product life-span together with the lack of patent protection on many medical devices, and the need to avoid delays by identifying and managing regulatory issues early can mean the difference between failure and success.

If you entertain the idea of participating in or drafting a device-protocol to pursue approval of an FDA-regulated device, you will need to consider and then determine the answer to the following questions:

• What category of device do you have?
• Is the device new or novel, or is there something else out there that compares to the device in question?
• Is this merely an improvement to a current device?
• Can you patent the idea?
• Have you or your study staff ever participated in or been a part of a device clinical trial?
• Are there current clinical data in support of the endpoint/outcome-point for the device and its effectiveness?
• Will clinical trials be needed, and if so, how many sites?
• How much money can you afford to put out in order to get the device approved?

The answers to these questions will help determine the precise steps that must be taken once the device is properly classified, and whether it is practical to proceed.

You must also plan for some delay. If the medical device falls within Class II or III, there will be an automatic 90-day hold-period after the submission of any required pre-market notification to the FDA. The hold means you cannot market the device to anyone until you receive approval during the 90 days, or until the 90 days expires without adverse action. It is critical to partner with a medical-device regulation expert because any failure to do it right the first time can result in costly do-overs and lengthy delays.

Conclusions

There is more pressure today on the FDA to get it right and ensure the safety of products in the marketplace than at any other time in its history. At the same time, consumers are savvier, and understand more about the options available to them as they choose medical care. Sponsors and clinicians who can anticipate issues with novel medical-devices before they become problems have a significant competitive edge versus those who choose to go it alone or simply hope for the best. And don’t forget that although the regulatory hurdles can be significant, meeting them sometimes confers a valuable collateral benefit: Federal preemption sometimes protects device manufacturers from costly state product liability claims.

Bottom line: Becoming familiar with the basic regulatory questions, and then accessing qualified experts in the complex and ever-changing field of medical-device regulation, helps you sell your ideas and get needed funding. Developing protocols from the outset that accommodate all regulatory angles will be far more likely to receive initial funding in a competitive environment, and thereafter succeed. And by following the regulatory steps, the industry can take enormous steps forward to create new and exciting medical device options to advance the good health of all mankind.

• A note from the editors: Guest author Cydney Boler, JD, MPH, is special counsel with Foulston Siefkin LLP, a law firm in Kansas. Attorney Boler represents bioscience and health care companies with clinical research compliance, clinical trial and research contracting, good clinical practices, and submission of applications for new medical devices and investigational drugs.

• B. Sonny Bal, MD, JD, MBA, is associate professor of hip and knee replacement in the department of orthopedic surgery, University of Missouri School of Medicine. Lawrence H. Brenner, JD, is on the faculties of orthopedics at Yale University and the University of Southern California and practices in Chapel Hill, N.C. Address all correspondence to Brenner at lb@lawrencebrennerlaw.com.