510(k) Pre-Market Notification
Class II medical devices, as described in Medical Device Classifications, are moderate risk devices and require regulatory controls to provide reasonable assurance of the device’s safety and effectiveness. Class II devices must comply with the General Controls associated with manufacturer registration, compliance with Design Controls, etc., but are also regulated by the 510(k) Pre-Market Notification process. This program, regulated by the FDA’s Center for Devices and Radiological Health (CDRH) is the most frequently used mechanism in the U.S. for initial marketing clearance of medical devices.
510(k) submissions may also be utilized to provide the FDA with updates involving changes that are planned, or in some cases that have already been implemented, regarding product design or labeling of currently marketed devices. Minor changes usually do not require clinical data support, and the application preparation is not burdensome. Other updates may be more involved and may require significant bench and/or clinical data, along with sound statistics to support, for example, new claims of safety and/or efficacy.
These more complex 510(k) submissions will frequently benefit from guidance that can be provided by FDA-experienced legal counsel.
Click on this link to visit a well-organized FDA site for guidance in this submission process
If you are developing what you believe should qualify as a Class I or II medical device, but which utilizes technology that may be unfamiliar to FDA reviewers ...
It’s important that you become familiar with recent FDA guidance (below) on determination of “substantial equivalency” to a “predicate” device, the primary requirement for seeking clearance to market a medical device under the 510(k) Pre-Market Notification process.
New FDA 510(k) Guidance Documents
In Dec, 2011, the FDA posted its intention to create a new guidance document that will merge and replace both of the pre-existing documents long used by medical device developers as their guide for 510(k) submission requirements.
Areas of focus for the new Guidance Documents are:
- Clarification of FDA requirements around the selection of predicate (substantially equivalent) devices
- Description of the principles that should be used in determining a device’s “intended use” and “indications for use”
- Introduction of a new requirement for the developer to name a “reference device”, along with better clarification of when, and whether or not, clinical data is needed to support a particular path of marketing clearance or approval
In July, 2014, the FDA issued guidance on the first of the issues above, entitled
Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] With Different Technological Characteristics
FDA states in this document that “…We believe the approach described in this draft guidance document would provide greater clarity regarding the factors that FDA considers in making substantial equivalence determinations when there are different technological characteristics between the new device and the predicate device that do not raise different questions of safety and effectiveness.”
Note: To paraphrase this FDA guidance, they clarify that “…in order to find a new device substantially equivalent to a predicate device, FDA must first find that the two devices have the same intended use. FDA must then determine that the two devices have the same technological characteristics, or that any differences in technological characteristics (significant change in the materials, design, energy source, or other features) do not raise different questions of safety and effectiveness, and that the device is as safe and effective as the predicate device.”
De Novo 510(k)
If, by FDA definition, your medical device is not considered a high risk device (i.e., does not support or sustain human life, is not of substantial importance in preventing impairment of human health, or does not present a potential unreasonable risk of illness or injury), and has been found to be not substantially equivalent (NSE) to a Class I, II, or III 510(k) – cleared device, then your device may be eligible for the “de novo 510(k)” process as a Class I or Class II device. For additional information on the de novo process, see Evaluation of Automatic Class III Designation: Guidance for Industry and CDRH Staff.
“Pioneering” Medical Devices ─ FDA Innovation Pathway
In February 2011, the FDA Center for Devices and Radiological Health (CDRH) introduced an initiative to develop a new priority review and approval process for “pioneering” medical devices, and to streamline the existing 510(k) de novo process. FDA introduced its intentions by way of a White Paper entitled the CDRH Medical Device Innovation Initiative, which is available through this link.
On April 9, 2012, CDRH launched its second version of the Innovation Pathway, called Innovation Pathway 2.0, which, according to the FDA, “… offers new and modified tools and methods to deepen collaboration between the FDA and innovators early in the process, prior to pre-market submission, with the goal of making the regulatory process more efficient and timely.”
NOTE: Currently only devices for end-stage renal disease are eligible to apply for clearance through the Innovation Pathway 2.0.
Visit this link for updates on this evolving area of medical device regulation.