When medical devices undergo changes, it leaves sponsors asking a critical question: Does the change require a new 510(k) submission?

Before trying to answer that question, it’s important to remember that the goal of assessing a new change is not to determine whether the new version of the device is substantially equivalent (SE) to the old one. 

Instead, you have look deeper into SE to get at its most basic component: determining whether or not the newly changed version “raise[s] different questions of safety and effectiveness than the predicate device.” 

If it does, a new 510(k) will be required. Once submitted, FDA will determine whether the newly changed version of the device is still substantially equivalent to a legally marketed existing device. 

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Risk management has become a central focus for regulators over the past few years, a point underscored by this year’s draft revision to ISO 13485.

Despite this, many device manufacturers don’t go far enough to incorporate the guidelines established in ISO 14971––exposing themselves to vulnerabilities and weaknesses investigators are looking for during inspections.

To help you reinforce your risk management system and avoid potential issues, we’ve pulled together a few of the most common issues companies face along with advice on mitigating them.

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In January of 2016, FDA released new guidelines for postmarket cybersecurity measures in medical devices.

These offer a number of best practices designed to assess and manage digital security vulnerabilities while detailing potential situations where hackers could gain access to patient records, or to the functions of a device itself.

While most of us are well aware of vulnerabilities to hacking when it comes to personal information, medical devices––especially those connected to a network––can be prime targets for malicous actors.

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Since the Orphan Drug Act was passed in 1983, developing drugs to treat rare diseases has become a more common practice among pharmaceutical manufacturers.

At the core of this legislation was the Orphan Drug Designation Program, which incentivised the development of drugs to treat rare diseases by awarding tax credits, grants, market exclusivity, fast-track approval and greater access to the Investigational New Drug Program. 

While this act has been a catalyst for powerful new treatments for decades, an amendment which eliminated user fees under PDUFA caused an explosion in designation requests, prompting FDA to make some changes to how these requests are approved.

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