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William Hyman: Precision Matters in Medical Device Terminology

December 20, 2016

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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 […]

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

November 16, 2016

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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, […]

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

August 23, 2016

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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 […]

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

April 21, 2016

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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 […]

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William Hyman: The FDA Again Addresses Material Specifications

February 18, 2016

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In what may be a trend, the FDA has again addressed material specifications, this time in a draft guidance document titled Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices.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 […]

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William Hyman: The FDA’s Scrutiny of Materials

January 29, 2016

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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, […]

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

January 13, 2016

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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 […]

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

January 7, 2016

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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 […]

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William Hyman: The FDA’s Advice on Archived Data Reliability

December 7, 2015

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In the context of its authority over mammography under the Mammography Quality Standards Act, the U.S. Food and Drug Administration has posted an advisory on technical aspects of digital record retention in picture archiving and communication systems or PACS. The primary issue addressed is loss of data due to failure of the equipment. This problem […]

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Matthew B. Weinger: The Path Forward for Satisfying User Interfaces in Health IT

November 10, 2015

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New rules, titled 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications were recently provided for public comment. In my opinion, these rules do not (yet) go far enough to assure safe and effective design and implementation of health IT. […]

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