It's a question that, even after careful consideration, can seem difficult to answer: Does the FDA actually "require" medical device manufacturers to perform risk analysis? If so, where?

The short answer is yes. But the topic requires a more nuanced discussion. We've summarized where the confusion stems from and how and where regulators require risk analysis below.

 

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The release of the Medical Device Regulations (EU-MDR) has put significant pressure on medical device companies to closely scrutinize the new regulations, assess the impact on their own organization, and implement compliant processes and procedures accordingly.

As important deadlines approach for implementing the final version of the EU-MDR, medical device manufacturers should be focused on planning and implementing their transition program now.

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International manufacturers subject to FDA oversight can expect, sooner or later, to be notified of an upcoming inspection at their facility.

After this initial notice, many companies have a few questions about what, if anything, they can expect to receive from FDA before investigators show up at the door.

The FDA follows general standard operating procedures for conducting foreign inspections and most who have experienced this themselves tend to agree that investigators typically adhere closely to them barring outstanding circumstances.

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 The FDA’s 2018 compounding policy priorities plan offers a first look at forthcoming new regulations the agency says it will issue later this year in response to growing concerns over the oversight of compounded drug manufacturing at compounding pharmacies and outsourcing facilities.

The plan also offers details into how the FDA will regulate compounding from bulk drug substances (active ingredients).

This will present new ways of complying with the agency’s restrictions on making copies of FDA-approved drugs. Lastly, the FDA also plans to clarify when it will rely on state regulatory authorities to oversee compounding pharmacies.

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As we enter the new year, it’s important to pause and look back the major trends in FDA enforcement that offer a valuable glimpse into what has changed from previous years and what we can likely expect in 2018.

We’ve focused on reviewing three areas of the FDA-regulated environment in particular: drugs, devices, and biologics.

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