Archive | Regulations RSS feed for this archive

Melissa Kozak: Put Device Users First with Human Factors-Informed Procurement

June 19, 2017

2 Comments

Think about the last time you saw a demonstration of a new medical device. Were you guided through all the new and innovative features by an expert who was able to step in and assist with any questions or difficulties as you tried it for the first time? Now think about the last time you […]

Continue reading...

William Hyman: Today’s Challenge? Keeping Track of Bills about Medical Device Regulation

May 9, 2017

0 Comments

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 […]

Continue reading...

William Hyman: Precision Matters in Medical Device Terminology

December 20, 2016

1 Comment

I have long been concerned (some might say obsessed) with the distinction between a medical device being “approved” and one being “cleared.” In simple terms, only a Class III device that has successfully traversed the PMA process has been approved. A Class II device that has reached the market via a 510(k) Premarket Notification has […]

Continue reading...

William Hyman: What Do FDA Inspections of Hospitals for MDR Compliance Tell Us?

November 16, 2016

0 Comments

Medical device reporting (MDR) is mandatory for hospitals and others captured under the definition of “device use facilities,” which does not include physician offices. Also subject to mandatory reporting are manufacturers for which this is a well-entrenched activity. The three categories of device-related events that must be reported are deaths, serious injuries, and, for manufacturers, […]

Continue reading...

William Hyman: Do We Know How to Evaluate and Compare Risks and Benefits?

August 23, 2016

2 Comments

It is well known that few things in life are risk free and that we therefore take on risk whenever we seek the benefits of healthcare. This leads to the straightforward notion that we should evaluate risks and benefits, and then compare them in order to make a rational decision about undertaking the activity. While […]

Continue reading...

William Hyman: The Mystery of ‘Updated’ FDA Web Pages

April 21, 2016

5 Comments

In the lower left-hand corner of most FDA web pages is a date given as “page last updated.” The straightforward understanding of this would be that either the whole page or something substantive on the page was changed on that date. In some cases, there is no other date associated with the information provided so […]

Continue reading...

William Hyman: The FDA Again Addresses Material Specifications

February 18, 2016

0 Comments

In what may be a trend, the FDA has again addressed material specifications, this time in a draft guidance document titled Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices. As with previous FDA comments on ventilator tubing, and as expressed in a guidance document on dialysis access devices, the issue here is […]

Continue reading...

William Hyman: The FDA’s Scrutiny of Materials

January 29, 2016

0 Comments

An ongoing issue in the use of materials for implanted or tissue-contacting medical devices is how specifically the material should be identified. I addressed this here earlier in the unexpected context of ventilator breathing tubes. As I noted then, the FDA seemed to be asserting a requirement for stricter testing of the gas contacting materials, […]

Continue reading...

Mary Logan: ‘Fit’ to Be Tied? Claims Aside, Fitbit Lawsuit Underscores Important Questions

January 13, 2016

9 Comments

What’s a medical device? The courts are going to have a field day for years to come with the first of what I predict will be many lawsuits about alleged inaccuracies in the growing number of consumer health and fitness products. A class-action lawsuit, alleging faulty heart-rate monitoring with an activity tracking device, has made […]

Continue reading...

William Hyman: Early (or Late) Warning with Medical Device Problems

January 7, 2016

2 Comments

Recalls typically are based on a conclusion reached by the manufacturer that there is a problem with a device that can lead to, for a Class I recall, serious adverse health consequences or death. For Class II and III recalls, the risk is proportionally lower. The recognition of a problem often begins with an increase […]

Continue reading...