The regulation of medical devices by the FDA remains a hot topic for makers of medical devices and HTM professionals, whether they are employed by hospitals, manufacturers, or third-party entities. There are at least seven ways that the regulation of medical devices could fundamentally change. Three of these are legislative in which a bill is enacted that revamps the law under which the FDA operates, directly changes a regulation, or otherwise orders the FDA to do something new or different. The other four are when the FDA, acting under its current authority (in its opinion) initiates a change in a regulation, creates a new regulation, issues a guidance document which in effect changes a regulation (even though in principle guidance can’t change regulations), or simply announces that, under its discretion, it is going to do something differently. HTM professionals are all too familiar with other regulatory changes that impact their activities, such as those from the Centers for Medicare & Medicaid Services (CMS), which are in turn reflected by The Joint Commission, while vendors pay close attention to CMS payment decisions.
Our professional media reports from time to time that one or another bill has been recently introduced. Then, a short or long interchange may ensue over the pros and the cons of the bill, often with considerable self-interest being displayed and/or alleged. It is important to note that most bills do not pass and may never emerge from committee. Of course some do pass, as illustrated by the 21st Century Cures Act which dictated some FDA regulatory changes, in part related to software.
Recent stories in various media I read have highlighted H.R. 2009: Fostering Innovation in Medical Imaging Act of 2017, H.R. 2118: Medical Device Servicing Safety and Accountability Act, and H.R. 2144: Risk-Based Classification of Accessories Act of 2017. Of these, HR 2118 has most energized the HTM community since it seeks to add a level of FDA regulation over third-party services.
As I read another “bill introduced” story, I wondered what else was out there. Fortunately, there are web services that can partially answer this question, including Govtrack.us (with which I have no association) which provides search-and-track function. Using the parameters “medical device” or “medical devices” revealed 17 pending bills in the House and 13 in the Senate. Because of search inaccuracies, some of these bills are not actually related to medical devices. On the other hand, some relevant bills were not picked up, such as H.R. 2144.
Using “FDA” as the search term yielding only 10 House bills. These bills are among nearly 4,000 bills and resolutions that are currently before Congress. GovTrack.us provides automatic tracking of bills via email alerts, and it gives a measure of the likelihood that a bill will pass. For example, the chances of the Medical Device Servicing Safety and Accountability Act making it into law is given as 1% . As an aside, GovTrack also records visits to its website from government computers in Congress and the White House. As it delightfully notes, “Since browsing history metadata is no big deal to Congress, we began publishing the browsing history of anyone visiting GovTrack.us from Congress’s and the White House’s office buildings”.
Congress.gov also provides a search function which yields different answers using the same search terms. Using “medical devices” results in 547 House bills and 249 Senate bills. Using “medical device” (singular) cuts the numbers to 43 and 26 respectively, a number of which are not actually relevant to devices. For example, there was HR 1068 Safe Drinking Water Act Amendments of 2017, which doesn’t actually contain the terms device or devices. Congress.gov does not providing tracking or chances of passage.
The proposed changes in the legislation can affect us in various ways, depending on where we are in the medical diverse universe, although one could argue that all such changes affect all of us. Keeping up with change can be a challenge. Keeping up with legislation that might effect change is part of that challenge, tempered by the reality that most legislation won’t be passed into law.
William Hyman, ScD, is an adjunct professor of biomedical engineering at The Cooper Union and a consultant in New York. He is also a professor emeritus of biomedical engineering at Texas A&M University