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FDA Works to Modernize 510(k) Process, Takes Aim at Predicates, De Novo Pathways

I began my career in the medical device and pharmaceutical industries in 1970 and have had the opportunity to see FDA’s 510(k) process evolve first-hand. From a standpoint of effectiveness and efficiency, the Premarket Notification process has certainly had its ups and downs since its origins in 1976.

Why the history lesson?

Because after 42 years, FDA announced several changes to keep up with new technologies and more sophisticated approaches to healthcare.

For medical device companies, the most important of these changes came in 4Q18 when as part of its new Medical Device Safety Action Plan, FDA announced a strengthened and more modern 510(k) pathway, used for clearance of low- to moderate-risk devices. This new pathway has a focus on predicate medical devices 10 years old or less. This framework is aimed at efficiently advancing beneficial technology to patients, while congealing FDA’s high standards for safety and efficacy. FDA is reaffirming its commitment to protecting patients by minimizing avoidable risks and advancing device technologies that are delivering growing benefits.

The Need for Modernization

In 4Q18, FDA broadcasted changes to modernize the 510(k) clearance pathway, which accounts for the majority of devices that FDA reviews every year. In 2017, the Center for Devices and Radiological Health (CDRH) cleared 3,173 devices through the 510(k) pathway, representing 82% of the total devices cleared or approved.

The Safety and Performance Based Pathway (finalized by FDA on January 22), focuses on progressively improving safety and performance of new products. The submitting company would demonstrate that a novel device meets modern performance-based criteria that have been established or recognized by FDA and reflect current technological principles in the industry. New devices that come to market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria. At the same time, the agency is reportedly going to pursue additional actions that will allow it to sunset outdated predicates, especially in cases where the industry has seen safer or more effective technology emerge. 

The 510(k) process allows FDA to recognize that medical devices exist across a continuum of complexity and risk, and that the scope of premarket review should reflect this risk-based approach. This is a contemporary slant to the regulation. A one-size-fits-all regulatory approach wouldn’t optimize public health outcomes, wouldn’t be efficient in advancing beneficial new technologies to patients and wouldn’t allow FDA to effectively prioritize its scientific resources.

CDRH staff have leveraged this paradigm to develop new regulatory policy. These efforts aim at adopting a more modern process that allows FDA to more readily incorporate new technologies. Some of the recent policies include efforts to:

  • Promote the use of authentic evidence in regulatory decision-making.

  • Modernize the De Novo pathway for low- to moderate-risk novel devices.

  • Enable the use of rigorous, consensus objective criteria to serve as a predicate for future clearances.

  • Build a national patient safety net.

  • Envision a regulatory paradigm for digital health products and in vitro diagnostics.

  • Diagram a premarket review path for breakthrough products.

Yes, it’s time to modernize the approach first adopted in 1976, when Congress considered the vast diversity of devices that would become subject to FDA’s regulatory oversight and established many of the predicate devices that served as the basis for 510(k) clearances during the last 42 years.

FDA believes in the virtues of the 510(k) process. It also believes that the present infrastructure needs to be modernized to reflect advances in technology, safety and the capabilities of a new generation of medical devices.



Yes, it’s time to modernize the approach first adopted in 1976, when Congress considered the vast diversity of devices that would become subject to FDA’s regulatory oversight and established many of the predicate devices that served as the basis for 510(k) clearances during the last 42 years.



The Predicate Conundrum

FDA is focusing policy efforts to help the 510(k) program keep pace with innovation, promote modern patient care and match our evolving understanding of benefits and risks. The most impactful way that FDA can promote innovation and improve safety in the 510(k) process is to drive designers and regulatory professionals toward a greater confidence in more modern predicate devices.

To advance these goals, in the next few months CDRH is calling out predicates that are more than 10 years old as a starting point, so that the public is aware of those technologies. Data shows that nearly 20%  of current 510(k)s are cleared based upon a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe, according to FDA. It does mean that some device classes may not be continually improving, which is expected in the health technology fields. FDA believes that encouraging product developers to use more modern predicates would:

  • Give patients and their doctors a choice among older and newer versions of a type of device.

  • Promote greater competition to adopt modern features that improve safety and efficacy.

  • Help make sure that newer devices reflect more modern technology and standards that can improve patient care and outcomes.

  • Assist the overall product environment to continue to evolve in the direction toward more modern performance standards.

FDA is implementing this market-based approach because the devices that are reviewed through the 510(k) process are increasingly complex. They often involve different technological features from the predicates upon which they’re based. Also, miniaturization of device components has allowed devices to become smaller and more portable. Devices more frequently use automation, robotics and advanced materials, changing the way that healthcare providers and patients interact with them. 

Note that FDA has increased expectations for the quality and quantity of information required in 510(k) submissions. This has resulted in a more than doubling of the size of submissions—a current average of 1,185 pages, compared to 475 pages in 2009.While FDA reviewers have spent more time appraising applications during this same period—an increase of about 32%—the average total time for the agency to reach a decision has decreased, believe it or not.

Additionally, FDA is soliciting public comment on steps it could take to further encourage device manufacturers to develop innovations based on newer products. By April 22, FDA seeks feedback on whether or not it should make public those devices or manufacturers who make technologies that rely on predicates that are more than 10 years old, whether other criteria should inform its point of reference, and whether the agency should take other actions to promote the use of more modern predicates.



While FDA reviewers have spent more time appraising applications during this same period—an increase of about 32%—the average total time for the agency to reach a decision has decreased, believe it or not.



De Novo Pathway: More Information Forthcoming

As a result of these latest 510(k) policy proposals, FDA believes that more devices will use the De Novo pathway, which permits a robust evaluation of novel devices and allows FDA to establish special controls for devices of the same type.

FDA plans to issue a proposed rule clarifying procedures and requirements for submissions of De Novo requests.

In 2018, two orthopaedic products received FDA clearance via the De Novo pathway: IlluminOss Medical’s Bone Stabilization System and Imagen’s OsteoDetect wrist fracture software.



John Gagliardi has had success over the past 45+ years in the medical device and pharmaceutical industries because of his practical approach to process-orientation and business. He has been actively involved in research and development, quality assurance, training, operations, process architecture, FDA inspections and regulatory affairs. Mr. Gagliardi specializes in building systems in a compliant and business-ready manner. Mr. Gagliardi can be reached by 
email.

MidWest Process Innovation, LLC

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