There are two main paths that medical device manufacturers
can use to bring moderate- and high-risk devices to market with the FDA’s
permission: through submittal of a premarket approval (PMA) request or 510(k)
PMA application is a more extensive approach, requiring substantial evidence
that provides “reasonable assurance that the device is safe and effective”
through methods like clinical trials, and results in FDA “approval.” This
process is reserved for high-risk Class III medical devices.
On the other
hand, the 510(k) process is shorter and less costly, and results in FDA
“clearance.” Applying for a 510(k) assumes a substantial equivalent, or
“predicate” device, can be clearly identified. While there is no specific
510(k) form, 21 CFR 807 Subpart E details clear requirements regarding design,
development, and documentation specifications for a 510(k) submission. As a
result of this transparency, medical device companies can face drastic
consequences if they fail to adhere to these detailed submittal requirements.
The product-centric advantage
Regardless of the approval route a device requires, the
premarket submission process can be strenuous. Even the abbreviated 510(k)
application requires about 25 types of documents that can result in
hundreds-to-thousands of pages of text and images. Despite the grueling nature
of these applications, adopting a product-centric approach throughout the new
product development (NPD) period facilitates a smoother premarket notification
process for medical device companies.
to the product record—which includes the
product’s bill of material (BOM) and is often comprised of multiple levels of mechanical,
electrical, and software components; assembly and test procedures; and other
associated documents critical for classifying the device—is a pivotal feature
for identifying a predicate device if needed, and for presenting correct and
accurate documentation for either submittal process. Additionally, eliminating disconnects
between product design, test engineering, quality, and supply chain teams
streamlines the submittal process and can aid companies seeking to demonstrate
substantial equivalence to a predicate device.
Missing a step at any point along the premarket application
path or failing to update the application with substantial product changes not
only delays a product’s time to market but, in extreme cases, can result in a
company shutdown due to an unmarketable product. As a result, the premarket
period is a critical time for organization and communication across both
product and quality teams.
How Arena can help
Arena provides a product-centric
QMS solution that provides a holistic view
of the entire finished device by tying quality
and regulatory events to the product’s relational BOM and its revision history.
During the pre-submittal period, Arena offers organizations
a solution to identify and gather the pre-submittal tasks and deliverables
while providing an electronic collaboration tool that will capture development
and verification activity. After submission, Arena helps companies by offering
configurable templates that can be generated to address 510(k) updates and
tasks that identify and track update actions. In addition, Arena can be
utilized to identify and capture registration and listing requirements by
Managing premarket approvals, as well as postmarket surveillance,
with Arena not only updates product records in real-time, but also helps
organize application and post-submittal documentation to ensure a smooth
compliance journey for the company.
Navigating 510(k) clearance or PMA
approval can be riddled with obstacles and slow time-to-market to a frustrating
pace. However, by adopting a product-centric approach, you can manage your
premarket submittal process smoothly and with confidence.
Are you struggling to aggregate your product records, or
dreading the arrival of a premarket application or postmarket study? What
specific challenges do you face? Let us know how
we can help you deliver high-quality products to market faster and more