FDA Announcements & Town Hall Meeting Summaries

From the weekly Town Hall Meetings hosted by the US FDA, our team translates and condenses the important points and guidances to provide an efficient way to keep you up-to-date.

FDA Submissions

There are several ways to submit a product to the FDA for premarket approval. Two of the most well-known methods are the 510(k) premarket notification and the PMA premarket approval. The less frequently used De Novo submission is another option. These submissions result in a decision from the FDA that grants marketing authorization, either through clearance [510(k)], approval [PMA], or De Novo clearance [De Novo]. Additionally, there are other forms of premarket submissions to the FDA, such as Pre-submissions, IDE (Investigational Device Exemptions), HDE (Humanitarian Device Exemptions), and Master Files. The most popular submissions are explained in further detail below.

510(K) Submissions

To legally sell a Class I, II, or III device intended for human use in the US, a Premarket Approval (PMA) is not always necessary. In these cases, the manufacturer must submit a 510(k) to the FDA unless the product is exempt from the requirements specified in the Federal Food, Drug, and Cosmetic Act and doesn’t exceed the exemptions listed in sections .9 of the device classification regulation chapters (e.g. 21 CFR 862.9, 21 CFR 864.9). The 510(k) is a premarket submission to the FDA that aims to demonstrate that the device is at least as safe and effective as a device that is already legally sold and not subject to PMA. The manufacturer must compare their device to similar products already on the market and provide evidence to support their claims of substantial equivalency. Marketing of the device cannot commence until the FDA gives the go-ahead, which is signified by an order declaring the device as substantially equivalent (SE). Once the device is deemed SE, it can then be sold in the US.

PMA

The Premarket Approval (PMA) process is a thorough scientific and regulatory review conducted by the FDA to assess the safety and effectiveness of Class III medical devices. These devices, which are deemed to have the highest level of risk, are crucial for supporting or maintaining human life, preventing health impairment, or posing a potential risk of injury or illness. Given the level of danger associated with Class III devices, the FDA determines that general and special controls are not enough to ensure their safety and effectiveness. Thus, these products must go through the PMA application process outlined in section 515 of the FD&C Act before they can be marketed. It’s worth noting that some Class III preamendment devices may require a Class III 510(k). PMA submissions typically contain technical sections, including non-clinical laboratory studies and clinical investigations, and an inspection of the facility is often required to ensure compliance with 21 CFR 820 prior to approval.

De Novo

The De Novo pathway provides a solution for marketing novel, low- to moderate-risk devices that lack a recognized predicate device. Upon the successful evaluation of a De Novo submission, the FDA will create a classification for the device, establish necessary regulations, and determine the special controls necessary for future premarket submissions of similar devices. Companies with low- to moderate-risk novel devices have two options when considering the De Novo pathway. They can either submit a 510(k) to the FDA and, if they receive a “Not Substantially Equivalent” determination, request a De Novo review, or they can skip the 510(k) submission and proceed directly with a De Novo request. Devices that go through the De Novo process can be marketed and serve as predicates for future 510(k) submissions.

Pre-Submission (Pre-Subs)

The Pre-submission process to the FDA serves as a means for obtaining feedback and guidance on a device before its formal submission for marketing clearance. This process can be utilized for a variety of reasons, including meeting requests, assessing risk, addressing submission-related issues, and seeking answers to specific questions pertaining to a future submission or study protocol. The Pre-Sub Program, previously referred to as the Pre-IDE Program, offers sponsors the opportunity to receive input from the FDA before submitting an IDE or marketing application. It also provides a channel for the Agency to offer guidance on the development of protocols for non-significant risk (NSR) device studies or those conducted outside of the U.S. to support future marketing efforts. The Pre-Sub program therefore represents an effective path to market while also supporting the FDA’s mission of promoting new medical device innovations.