Thanks! You've successfully subscribed to the BONEZONE®/OMTEC® Monthly eNewsletter!

Please take a moment to tell us more about yourself and help us keep unwanted emails out of your inbox.

Choose one or more mailing lists:
BONEZONE/OMTEC Monthly eNewsletter
OMTEC Conference Updates
Advertising/Sponsorship Opportunities
Exhibiting Opportunities
* Indicates a required field.

FDA Seeks 21st Century Agility with 510(k)s

Working with the Premarket Notification, also known as the 510(k) process, since 1978 has allowed me to view the big picture of definitive ups and downs in the challenging device submission process. Over the last 15 years, the regulatory landscape has changed from a standpoint of FDA and industry expectations, submission efficiency, user fees, complexity, guidance document creation, risk-based decision-making and FDA interaction.

I recall the 1980s Agency-wide initiative to reduce the amount of time it took to trudge through the submission process. Many 510(k)s took over a year from start to finish. Then in the 1990s and into the early 2000s, rapid fire results became in vogue in D.C. I can remember successfully filing a submission that took 28 days. I’ll never forget it. Conversely, I want to forget the one that took more than 328 days.

In this article, I will outline new initiatives by FDA to streamline the occasionally cumbersome 510(k) submission process. The “new FDA” seeks an innovative agility that includes greater accuracy, proper documentation without encumbrances, foundations built on science and engineering, formal guidance documents, risk aversion decisions and, yes, a more interactive FDA.

Background Information: FDA Develops a Tiered System
A person or company that intends to introduce a device into commercial distribution is required to first submit a 510(k) to FDA. FDA may issue an order of substantial equivalence once it has determined that the device meets requirements that prove it is as safe and effective as a legally marketed device. In order to ensure Premarket Notification requirements are met, the Agency developed a tiered system that allocates more of its review resources to high risk devices. Under this tiered system, substantial equivalence determination for low risk devices is based primarily on descriptive information and a review of the label, while the decision for higher risk devices considers performance data.

FDA Lightens its Self-imposed Burden, Exempting Class I Devices
To optimally manage workload and allocate resources, FDA exempted Class I devices for which it determined that Premarket Notification requirements were not needed to provide reasonable assurance of safety and effectiveness.

Between the passage of the Medical Device Amendments of 1976 and the Food and Drug Administration Modernization Act (FDAMA) in 1997, FDA exempted 574 generic types of Class I devices from Premarket Notification. As a result, Class I devices are exempt from Premarket Notification requirements, unless the device meets “reserved” criteria, meaning it is intended for a use that is of substantial importance in preventing impairment to human health or presents a potential unreasonable risk of illness or injury.

The passing of FDAMA also gave FDA the authority to exempt certain Class II devices rather than down-classifying them to Class I before they become eligible for exemption. FDA has noted that additional Class II devices may become exempt from Premarket Notification in the future.

The Agency’s last step in evaluating devices subject to 510(k) review involves pre-amendments Class III devices. FDA plans to down-classify pre-amendment Class III devices for which general controls or special controls are sufficient to ensure safety and effectiveness to either Class I (510(k) exempt or reserved) or to Class II. The remaining Class III devices will be subject to either Premarket Approval (PMA) or product development protocol (PDP) requirements.



Continue reading about the
FDA approval process:


FDA Clarifies Substantial Equivalence Requirements for 510(k) Submissions


The Starting Line: Turning the Corner with a Device Concept  

4 COMMENTS

Security code
Refresh