About FDA Regulatory Approval
Virtually all medical devices require approval from FDA before they may be legally marketed in the United States. The most common approval types are the 510(k) Premarket Notification, the Premarket Approval (PMA), and the De Novo Request. The applicable approval type is determined by the relevant device classification:
- Class I devices are generally exempt from FDA approval but may need to undergo the 510(k) Premarket Notification process.
- Class II devices require the 510(k) Premarket Notification process to demonstrate equivalence to a legally marketed device.
- Class III devices require valid scientific evidence for approval.
How Obelis can support you
Regulatory submissions require the preparation of a dossier for evaluation by FDA. Incomplete submissions may cause significant delays and extra costs for the manufacturer. As such, it is essential that the applicant is knowledgeable of FDA requirements, procedures and expectations.
At Obelis, we offer expert support in determining the correct classification and approval path, as well as preparing and submitting regulatory dossiers that meet FDA expectations.
Background info on processes
Most devices falling in class II (and in some limited cases, in class I or III) must follow a Pre-Market Notification procedure to be “cleared” by FDA, before they can be introduced in the US market. The Pre-Market Notification procedure is commonly referred to as “510k procedure”.
In a 510(k) procedure, the sponsor must demonstrate that the new device is “substantially equivalent” to a legally marketed device (also known as “predicate”) in terms of intended use, technological characteristics, and performance testing.
The assessment from FDA is completed within 90 days from the moment the information is submitted.
Premarket Approval (PMA) is the FDA’s most stringent type of marketing application. It is a rigorous scientific and regulatory evaluation process used to assess the safety and effectiveness of high-risk medical devices (mainly class III).
The approval decision is based on whether the application provides sufficient, valid scientific evidence demonstrating that the device is both safe and effective for its intended purpose.
PMA Review Process
The FDA evaluates premarket approval applications through a structured four-step review process:
- Initial Administrative Review – A preliminary assessment by FDA staff to ensure the application is complete and ready for full review.
- Comprehensive Scientific and Regulatory Review – A detailed evaluation of the application’s data, including compliance with FDA quality regulations.
- Advisory Committee Review (if applicable) – An external advisory panel may be consulted for additional expert recommendations.
- Final Decision and Notification – The FDA completes its assessment, documents the findings, and formally communicates its decision.
The first stage, administrative review, is typically completed within 45 days. The substantive review (steps 2 to 4) is generally expected to conclude within 180 days. However, if the FDA requests additional information, the review timeline may be extended.
The De Novo process offers a regulatory pathway for novel medical devices that lack a legally marketed predicate but can still be classified into Class I or Class II. There are two ways to submit a request:
- Following a 510(k) Submission: If the FDA determines that a device is not substantially equivalent due to the absence of a valid predicate, a new intended use, or significant technological differences that raise new safety and effectiveness concerns, a De Novo request may be submitted.
- Direct De Novo Submission: Manufacturers may choose to submit a De Novo request directly if they determine that no legally marketed device exists for comparison, bypassing the 510(k) process entirely.
The De Novo review process consists of 3 main stages:
- Acceptance Review: FDA conducts an initial administrative review to check for completeness.
- Substantive Review: FDA evaluates whether a similar legally marketed device exists. In case of deficiencies in the submitted information, FDA will request additional data from the applicant.
- Final Decision: FDA deliberates on the request and communicates the final decision to the applicable. The decision is normally issued within 150 review days.
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