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    Cybersecurity: FDA Spells Out Updated Premarket Policies

    With its first guidance in the device space in FY 2019, the US Food and Drug Administration (FDA) unveiled an awaited draft guidance on Wednesday to clarify the agency’s cybersecurity expectations from a premarket perspective. The draft guidance is an update to 2014 premarket policies on cybersecurity and came as the ink was still wet on the memorandum of agreement (MOA) between FDA and the US Department of Homeland Security (DHS) for strengthening a coordinated approac...
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    FDA Amends Definition of Custom Device

    The US Food and Drug Administration (FDA) on Tuesday released a final rule that amends its regulations on the definition of a custom device so as to include new statutory requirements under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). Under the revised provision, as under the original custom device exemption, a device that meets the qualification of a custom device is exemp...
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    FDA Looks to Fine-Tune the Balance Between Premarket Device Data and Postmarket Requirements

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Monday announced that it has completed its target goal under its 2014-2015 strategic priority on striking the right balance between premarket and postmarket data. The goal for CDRH was to review 100% of the medical devices subject to a premarket approval applications (PMAs) approved prior to 2010 to determine, for each product code, whether or not to reduce premarket data co...
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    FDA Finalizes Guidance on Safety Data Collection for Late-Stage and Postapproval Trials

    The US Food and Drug Administration (FDA) on Thursday significantly revised and finalized guidance originally released in 2012 that will help industry understand what types of safety data needs to be collected in late-stage premarket and postapproval clinical investigations. “This guidance provides recommendations on when to consider selective safety data collection and how to do so to maintain a balance between eliminating the collection of data that will not be us...
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    FDA Offers New Insight on When to Submit PMA Supplements for Device Manufacturer Site Changes

    Medical device companies trying to understand what officially constitutes a manufacturing site change and when to submit a premarket approval (PMA) supplement will want to consult with draft guidance from the US Food and Drug Administration (FDA) released Tuesday. According to FDA, the agency has received a number of questions on various scenarios that might require a device manufacturer to use a different site for manufacturing, processing or packaging a device. In...
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    Are You a Good Witch, or a Bad Witch?

    Regulatory intelligence is at the heart of every well-informed regulatory decision, and is integral to maximizing effectiveness and influence for the regulatory professional.  The Regulatory Intelligence Quotient is a regular exploration of regulatory intelligence topics by thought leaders in the field. Want to learn more or suggest future topics? Contact us at asksofie@graematter.com Upon meeting Dorothy in The Wizard of Oz, Good Witch Glinda asks “Are you a ...
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    Eight Additional Device Classes Exempt from Premarket Notification Requirements

    In July, the US Food and Drug Administration exempted some 120 medical device classes from its premarket notification and review requirements. Now, FDA has announced it is exempting additional device classes from these requirements, after an administrative error caused the agency to miss some comments from a public consultation. Background In 2012, during the third Medical Device User Fee Act (MDUFA) talks, FDA committed to reducing regulation on certain low-ris...
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    FDA Isn't Waiting Around for 'Cures' to Speed Access to Devices

    While the Congress is busy working on the 21st Century Cures Act , which is expected to speed access to new drugs and devices, a new report from EP Vantage shows FDA isn't sitting on its hands. 2015: A Record Year for Device Approvals? In the first half of 2015, FDA has already cleared 26 devices with either premarket approval (PMA) or a humanitarian device exemption (HDE). To put that in perspective, in half a year FDA has already granted more PMAs and HDEs to new ...
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    FDA Exempts 120 Medical Device Types from Most Regulation

    The US Food and Drug Administration (FDA) plans to exempt 120 medical device classes from its premarket notification and review requirements, making it substantially easier for companies to market the devices. Background Under existing regulations, FDA regulates devices according to three general categories: Class III – High-risk devices; require the submission of a Premarket Application (PMA). Class II – Moderate-risk devices; require the submission of a Premarket N...
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    New FDA Program to Expedite the Approval of 'Breakthrough' Medical Devices

    The US Food and Drug Administration (FDA) has put the finishing touches on two policies intended to expedite access to potentially life-saving devices meant for patients with life-threatening diseases or conditions. Background FDA's Center for Devices and Radiological Health (CDRH) has for several years been putting the finishing touches on two conceptually related guidance documents: Expedited Access for Premarket Approval and De Novo Medical Devices Intended for U...
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    Does FDA Take Longer to Clear 510(k)s From Non-US Companies?

    Regulatory intelligence is at the heart of every well-informed regulatory decision, and is integral to maximizing effectiveness and influence for the regulatory professional. The Regulatory Intelligence Quotient is a regular exploration of regulatory intelligence topics by thought leaders in the field. Want to learn more or suggest future topics? Contact us at asksofie@graematter.com With respect to FDA 510(k) premarket clearances, the country where the submitter i...
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    The Future Will be Regulated: FDA Asks for More Information on Robotic Exoskeleton

    The future is here. The future will be regulated. Those are two possible conclusions from an announcement this week by Ekso Bionics, which said its robotic exoskeleton—intended to help paralyzed patients walk by augmenting their strength—must meet additional regulatory requirements put in place by the US Food and Drug Administration (FDA). At issue is the method in which Ekso Bionics' "wearable bionic suit," Ekso, is supposed to be reviewed by regulators before it is all...