It has been a little over a year since the FDA issued a memo outlining the reorganization they would undertake to change inspection activities. This plan is expected to better align resources in order to achieve their objectives. At its core, the change will move the agency from a regionally based system to a product focused method. Each region currently has a mixture of investigators that are generalists with those that are product specific. To first develop the expertise necessary, product types will be identified within certain programs.
Continue reading "The New Inspectorate"
The FDA has recently issued guidance regarding the risk of device accessories. They will no longer be considered as part of one big happy family included in the risk of the parent device. This new proposal states that the classification for a medical device accessory should be based on the risk they bring when used with the parent and not based on the parent’s risk. This applies to many items including apps and other connectivity technologies. This will require additional work for the manufacturer to assess the risk of perhaps multiple additions to a device.
Continue reading "Device Add-Ons- Separate but not Equal- Maybe."
In today’s technology obsessed world, even the delivery of healthcare is dependent on software driven devices. Some are standalone, others are networked together. With the ever growing web of connectivity and the movement towards personal medical care, security issues predictably arise. Hacking has become so common place, we are no longer surprised when it happens. Losing your credit card information is bad enough but what if a wearable device was compromised by an anonymous cyber criminal? Remember, the motivation for someone to control another individual’s pacemaker or insulin pump is irrelevant, the point is that if something can be hacked, someone will find away to do it. Hackers may use these devices as another means to troll for personal information.
Continue reading "Medical Device Security-Beyond a Data Breach"
Managing validation document lifecycles and deliverables can be error-prone and time-consuming. Which leads to the question: "Can paperless validation be a reality?"
Join us for our Green Validation Webinar on Tuesday, February 24th, at 12:00pm Eastern (9:00am Pacific) as Valarie King-Bailey, CEO of OnShore Technology Group, discusses effectively managing validation processes and documentation in a consistent and green manner.
This session will cover the following topics regarding ERP validation:
- Initiating the validation activities early in an ERP project.
- Eliminating paper documentation and slow approval processes.
- Reducing time to completion by 50%.
Learn how to ensure compliance, streamline validation, and reduce costs by registering now for this webinar!
And then take a look at the other upcoming sessions we have in our Mastering Compliance and Innovation Life Sciences Webinar Series.
Merit Solutions and OnShore Technology Group are excited to launch a new monthly Life Sciences Executive Webinar Series titled "Mastering Compliance and Innovation”. This series will identify ways Life Sciences organizations can excel beyond the basics and leverage innovative technologies to achieve continuous improvement and global success.
Continue reading "Life Sciences Executive Webinar Series - "Mastering Compliance and Innovation""
There are significant challenges to meet the regulatory requirements to sell products globally. It is necessary to be audited by regulators from these countries or by an accredited independent group. In some cases, countries will not accept a report that was generated for another jurisdiction. For some companies this can mean subjecting to many inspections and for international regulator’s inspectors to rack up the miles. This can become expensive and also slow the process of new product introduction.
To address this issue some regulatory authorities are developing a program to allow a single inspection team from a recognized auditing organization to satisfy the requirements of the participating countries. The Medical Device Single Audit Program (MDSAP) is in a pilot phase. This has the potential to be a win-win for both regulators and manufacturers as they can utilize their resources more efficiently.
Continue reading "MDSAP: Another Attempt at a One Size Fits All Audit"
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.
Continue reading "What Keeps You Up at Night? 2014 in Review for Medical Device Companies"
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.
Continue reading "510(k) Clearance Without the Snags"
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.
Continue reading "Individualized Care, Big Data and Privacy"
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.
Continue reading "When it Becomes Criminal"