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What Keeps You Up at Night? 2014 in Review for Medical Device Companies

Quality compliance is never a static concern. With changes in programs and new guidance documents it may feel like trying to hit a moving target. During online discussions, many device manufacturers indicated that their areas of biggest concern were inspections, followed by product recalls, warning letters, UDI implementation and CAPA. Clearly, no one is alone in their concerns.

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510(k) Clearance Without the Snags

In the US, there are two regulatory processes used to obtain marketing clearance for a device. 510(k) is a type of premarket submission where there is a substantially equivalent predicate device. Without this comparison, the submission would require a PMA (Premarket Approval). This process applies to most class II devices. The submission must demonstrate the same safety and effectiveness characteristics of the predicate device. A successful submission results in the permission to distribute and sell. A PMA requires evidence from controlled trials to prove the safety and effectiveness of the device.

The submission process is challenging and it changes periodically so it is important to keep current. In December, the FDA issued draft guidance on how it tracks clearances that change ownership. This can happen when a product or company is divested to another. The FDA receives notification of this change but difficulties can sometimes arise when trying to trace the history. The electronic registry developed in 2012 facilitates this tracking. Regardless of the past ownership, there remain key issues to focus on when preparing the submission.

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Individualized Care, Big Data and Privacy

It seems with every key stroke, data is collected and stored by a third party. This huge amount of information may be a treasure trove for companies to learn more about the effectiveness of a treatment or the performance of a device. Some say it holds great potential for improving patient care. But like most big data stockpiles, others become squeamish at the thought of alternate uses for the data.

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When it Becomes Criminal

When the FDA warns of further enforcement, it is not just an attempt to intimidate. There are teeth behind this procedure and companies need to stand up and take notice. Ignoring or excessively delaying a response will not make it go away, the ramifications will only increase.

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The Road to Clearance - Avoiding Refusal

Continuing improvement of the 510(k) process took shape in late 2012. Medical device companies have been frustrated by the length of time it takes the FDA to review submissions. The agency believed that the state of some of the submissions was a contributing factor.

Enter the Refuse to Accept policy (RTA).

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E-Health Services: The New Boon

E-Health services and wireless, wearable devices are spawning new products regularly. Last year monitoring devices grossed $2.9 million and is expected to grow to $17.1 million over the next five years. There is increasing demand for expanding the old point of care paradigm from the traditional hospital/doctor’s office setting to a more mobile medical environment. With this expansion, come new challenges with compatibility, wireless performance, security and compliance with the somewhat fledgling regulations.

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Recalling the Difference

Last year the FDA issued a draft guidance to clarify the difference between a recall and a product enhancement. Only voluntary recalls are in scope and whether they are performed by the manufacturer or at the request of the FDA is irrelevant. The difference is important as a recall requires the submission of a correction and removal report to the FDA. These reports become part of public record and thus may not put the company in a positive light. What may be considered recalls can include updates to instructions or changes to components or labeling.

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Choosing a Contract Manufacturer- It's All in the Family

With increased scrutiny on the supply chain and rising complexities, finding a dependable manufacturing partner is critical. Outsourcing to a contract manufacturer may seem like an easy thing to do if your company does not have the expertise, equipment or capacity to manufacture a product. You turn to a distant family member to fill in the gaps and move on to something else. However, if not sufficiently evaluated or controlled, the solution becomes the crazy aunt you wish would go away. Ultimately, the sponsor company is accountable to ensure that the contract manufacturer is compliant with cGMP and applicable Quality System Regulations.

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Device Design Transfer - A Smooth Hand-off

Getting a new product into the customers hands as quickly as possible is critical to medical device manufacturers. Perhaps during the rush to hand off a product to the manufacturing floor, corners are cut. The end result can be manufacturing delays that prevent the product from going out the door - or even defective product reaching the customer.

Paying attention to the details up-front can save time in the long run. Resolving issues early in the process lends itself to a seamless transfer in house or to a contract manufacturer.

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Not Obstructing the FDA - Be Reasonable

A little over a year ago, the FDA issued a draft guidance document (Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection) regarding the types of actions that would be considered to obstruct an FDA inspection and potentially lead to a supposition of adulteration. Last month, the final guidance was issued. The document attempts to define what behaviors are considered to mean an intentional delay or refusal. The FDA has the authority to enter any facility under the jurisdiction of the FD&C Act at reasonable times and conduct inspections.

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