In the first installment of this three-part article series, experts detail the requirements for complying with medical device postmarket surveillance regulations and describe potential sources for postmarket data.

Kevin Ong, PhD, PE, Michael Frohbergh, PhD, Jennifer Stevenson, Esq., and John Constance, Esq.

Editor's note: This is the first installment in a three-part series detailing the ins and outs of medical device postmarket surveillance. Read Part 2 and Part 3....

December 13th, 2016
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The medical device industry’s biggest players spent billions in 2016 snapping up smaller companies and shuffling business units. These transactions are shifting the medtech landscape but, in some cases, haven’t proceeded as planned.

Marie Thibault

This was yet another year filled with mergers and acquisitions in the medical device industry, with several mega-deals valued well over $1 billion. Many of these transactions are rearranging the order of top players in various device sectors or entirely remaking a technology field. In addition to some of these evolutions, a couple of transactions haven’t moved forward as expected. All of this has added up to exciting and fast-paced changes in the medtech industry.

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December 12th, 2016
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In the final installment of this three-part article series, experts explain the legal issues surrounding medical device postmarket surveillance.

Kevin Ong, PhD, PE, Michael Frohbergh, PhD, Jennifer Stevenson, Esq., and John Constance, Esq.

 

Editor's note: This is the last installment in a three-part series detailing the ins and outs of medical device postmarket surveillance. Read Part 1 and Part 2.

Legal Issues Pertaining to...

December 11th, 2016
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These were the most important guidance documents of the year for medical device manufacturers.

Gordon MacFarlane, PhD, RAC and Cynthia Nolte, PhD, RAC

This year FDA again issued several guidance documents that have substantial, positive implications for portfolio productivity and strategy. The following 2016 guidance documents merit careful consideration by every device manufacturer.

Adaptive Designs for Medical Device Clinical Studies (Final Guidance)

What FDA Says: Guidance on planning and implementing adaptive designs for clinical studies used in medical device development....

December 9th, 2016
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FDA announces it will consider creating a class of over-the-counter hearing aids and will remove certain requirements in order to make the devices easier to access.

Marie Thibault

FDA cuts straight to the heart of the hearing aid debate, announcing that it will consider creating a category of over-the-counter hearing aids. In addition, the agency said the current rule requiring patient to undergo a medical evaluation or sign a waiver before buying a hearing aid will not be enforced.

The agency's decision—issued in the form of a December 7 "Immediately in Effect Guidance Document"—came just days after ...

December 7th, 2016
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Phenotyping, describing the patient on a clinical level, has emerged as a necessary step in helping clinicians diagnose rare and ultra-rare genetic diseases. 

Dekel Gelbman

Diagnosing rare and ultra-rare genetic diseases can be extremely difficult for geneticists. The diagnostic odyssey, from the primary point of care, through the specialty clinics and to the molecular testing labs, can take up to 7.6 years to come to an appropriate diagnosis. According to recent survey results, patients living with rare diseases visit an average of 7.3 physicians before receiving an accurate diagnosis. This process can be compared to solving a mystery, with the geneticist...

December 5th, 2016
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HeartWare

Device: Batteries used for the HeartWare Ventricular Assist Device (HVAD) with serial numbers BAT000001 to BAT 199999, model number 1650.

Recall reason: According to information on the FDA recall page, "the batteries . . . may lose power prematerly due to faulty cells." If another power source is not connected, "the pump will stop working and the patient may experience serious adverse health consequences, including death."

When recall was initiated: January 7, 2016

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December 2nd, 2016
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Boston Scientific

Device: Certain lots of the Fetch 2 Aspiration Catheter, model number 109400-001. Click here for affected lot numbers.

Recall reason: According to information on the FDA recall page, "the catheter shaft may break at various points along the device . . . If breakage occurs while the device is in a patient, pieces of the catheter may block blood supply to the heart or blood vessels. This could result in the need for additional medical procedures, patient injury, or death."

When recall was...

December 2nd, 2016
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Arrow International

Device: Specific models of Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits

Recall reason: According to information on the FDA recall page, "the sheath body may separate from the sheath hub during the insertion procedure. This may cause significant bleeding . . . and an interruption of the inflating-deflating balloon therapy."

When recall was initiated: February 10, 2016

Number of U.S. units impacted: 13,405 units

For more information, visit the ...

December 2nd, 2016
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Cook Medical

Device: Cook Medical's Single Lumen Central Venous Catheter Sets and Trays; Single Lumen Pressure Monitoring Sets and Trays; Femoral Artery Pressure Monitoring Catheter Sets and Trays; Radial Artery Pressure Monitoring Catheter Sets and Trays. Click here for affected lot numbers.

Recall reason: According to information on the FDA recall page, "the tips may split or separate from the catheters due to a manufacturing error . . . the tip could enter the patient's blood...

December 2nd, 2016
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