MDDI_Medical Device & Diagnostic Industry

MDDI, July 2016

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24 | july 2016 Image courtesy of zhz_akey/iSTOCkPhOTOS.COM I n the first half of 2016 (and at press time), CDRH had released 13 draft guidance and nine final guidance documents covering topics as varied as cybersecurity for medical devices in the postmarket setting to technical considerations for additive manufactured de- vices. In addition to these official publications, FDA officials have communicated new agen- cy initiatives via the agency's FDA Voice blog. A couple of major regulatory stories in the first half of the year were motivated by patient activism instead of formal pronouncements from the agency. Finally, plenty of regulatory developments have taken place outside of the United States. Here's a recap of the most important regu- latory news you need to know so far in 2016. FDA Proposes 'Emerging Signals' While this announcement actually came on the last day of 2015, it signaled the agency's response to heightened patient activism surrounding certain medical devices and associated adverse events. FDA's proposal would allow it to tell the public about emerging signals for postmarket medical devices "even when the information has not been fully analyzed, validated, or con- firmed, and for which the agency does not yet have specific recommendations." This could improve adherence with adverse event reporting practices and may allow patients and clinicians to make care deci- sions with more information. Two Device Bans Proposed More than 30 years after the first and only medical device—prosthetic hair fibers—was banned by FDA, the agency proposed ban- ning two more devices. First were powdered medical gloves, a product that had been on the agency's radar for almost 20 years. Pow- dered medical gloves carry the risk of inju- ries like respiratory allergic reactions, severe airway inflammation, wound inflammation, and postsurgical adhesions. In April, FDA proposed banning electrical stimulation devices (ESD) that are used for aggressive or self-injurious behavior. These devices are only made and used by The Judge Rotenberg Educational Center Inc., a special-needs school in Canton, MA. ESDs are associated with risks like PTSD symptoms, pain, burns, tissue damage, and unexpected shocks in case of a malfunction, according to FDA. Speaking of Bans . . . Patient activists would like to see the Essure permanent birth control device taken off the market, but instead FDA published draft guidance with details of a mandatory warn- ing that will be placed on Essure product boxes. Along with the boxed warning is lan- guage that explains the potential for serious adverse events and a checklist of topics to be Regulatory Highlights from the Regulation FDA and other global regulatory bodies have been busy in 2016. These are a few of the biggest regulatory developments so far this year. MArIE ThIBAulT FiRst HalF oF 2016

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