As of March 29th, 2019, FDA has issued two draft guidances relevant to inspections of domestic and foreign medical device establishments.

The first, issued by FDA’s CDRH in February, identifies a new standard mechanism for device establishments to request nonbinding feedback on actions proposed to address FDA Form 483 observations.

The second, issued by FDA in March, seeks to implement uniform processes and standards for FDA inspections of domestic and foreign device establishments.

Below, we’ve summarized the key takeaways from both of these draft guidances along with general advice for contextualizing and considering action.

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The FDA recently issued its final guidance intended to help the medical device industry determine applicable requirements for making a change to a medical device manufacturing site.

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Many FDA-regulated manufacturers find themselves without the resources or processes to efficiently manage product complaints. When the resulting backlog isn’t cleared quickly and completely, the issue can compound into serious safety and compliance problems requiring many hours of work to resolve.

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Corrective and Preventive Action (CAPA) routinely tops the list of most-cited inspectional observations year after year, making it a clear target for investigators. When problems are found in your CAPA program, it can open your broader QMS up to intense scrutiny.

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In FDA-regulated manufacturing, genuine human errors do occur but they’re cited far more frequently than they probably should be.

In truth, most problems that appear to be caused by human error — especially those that occur multiple times — are actually rooted in processes or systems that when left unchanged, will keep producing the problem despite the convenient band-aids often placed over them.

When human error is identified more frequently than it should be expected to happen, it signals to investigators that problems aren’t being internally investigated thoroughly enough. This can quickly shift the investigator into problem-hunting mode and open your quality management system up to even greater scrutiny.

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Given the numerous inspectional observations citing insufficient established CAPA procedures, it’s worth revisiting what regulators expect to see from your CAPA process.

In a 2014 presentation, FDA’s Joseph Tartal described the basics of effective corrective and preventive action—a resource every company should use to evaluate against their own processes. Among many important points, one stands out as particularly useful when for ensuring FDA CAPA compliance:

“Manufacturers should consider that their corrective action and preventive action documentation can demonstrate to FDA that the manufacturer’s quality system is effective and enables the manufacturer to identify problems quickly and implement effective corrective and preventive actions (or not).”

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To improve medical device safety, the HHS Office of the Inspector General (OIG) is recommending that the FDA better integrate cybersecurity criteria into its premarket review process for medical devices.

In its September, 10th report, OIG advised the FDA make three specific improvements related to cybersecurity, all of which the agency says it is currently working to adopt:

  1. Include cybersecurity documentation as a criterion in its Refuse-to-Accept (RTA) checklist.

  2. Use presubmission meetings with manufacturers to address cybersecurity-related questions.

  3. Add cybersecurity questions to its 'Smart' template, which guides FDA's review of medical device submissions.

We've summarized the details of each of these changes to the premarket review process along with general preparation advice for affected device manufacturers.

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The Eight Disciplines (8D) model is a problem-solving methodology used primarily within the automotive industry to identify root causes, correct them in the short term and prevent them in the long term.

Given its reputation for reliability in the automotive space, it's no surprise the method has been embraced by engineers in other industries tasked with solving similar types of problems. Drug and device manufacturing is one such space where 8D seems like a fit, particularly within corrective and preventive action (CAPA) programs.

But despite its success, the 8D model presents a serious compliance problem under both FDA and global ISO regulations––one that regulators are seizing on as evident by the top-cited inspectional observation within the device space since 2010: "Procedures for corrective and preventive action have not been [adequately] established."

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The European Commission has released the first guidance for the upcoming Medical Device Regulations (EU MDR) and In Vitro Diagnostic Regulations (IVDR).

Both the EU MDR and IVDR replace the existing Directives, however, the new rules will only apply after a transitional period. For MDR, this period is three years after entry into force (spring 2020). For the IVDR, this period is five years after entry into force (spring 2022).

More recently in March of 2018, a document regarding the requirements for a future EU medical device nomenclature was endorsed at the meeting of the European Medical Devices Coordination Group (MDCG). Access the full document here.

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The new Medical Devices Regulation (EU-MDR) brings a number of significant changes, putting pressure on all impacted parties to closely examine the Regulation, assess the impact it will have on their own organization, and implement compliant processes and procedures accordingly.

Since MDR’s release in 2017, many regulatory experts have published and circulated resources aimed at helping companies understand the new rules and adjust their organizations accordingly. While many of these resources are extremely useful, we set out to offer a tangible, step-by-step guide that can be adapted to fit the needs of many companies. 

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