Jun 23 2022
Medical devices marketed in the United States are subject to the regulatory controls in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the regulations in Title 21- Code of Federal Regulations (21 CFR) Parts 1-58, 800-1299. The regulatory controls and marketing pathways are based on the risk of the device the regulatory controls needed to ensure reasonable assurance of safety and effectiveness.
The marketing pathways include: Premarket Notification (510(k)), De Novo Classification Request, Exempt, Premarket Approval (PMA), Product Development Protocol (PDP), Humanitarian Use Exemption (HDE), and Biologics License Application (BLA).
1. Establish the Product
- Identify product (device) description
- Identify purpose
indications for use
duration of use
target patient population
2. Verify that Product is Medical Device
3. Identify Classification and Regulatory Pathway
Identify regulatory classification
Classification will generally indicate regulatory pathway (premarket submission type) required for device
4. Develop Valid Scientific Evidence
21 CFR 860.7(c)(1) – requires valid scientific evidence for safety and effectiveness
21 CFR 860.7(c)(2) – provides definition of valid scientific evidence
5. Prepare Premarket Submission
Bringing a device to the market in the United States may appear complex.
Following these four steps may assist you to navigate the process.
Four steps to bring a device to the market:
The most common types of premarket submissions include :
Most Class II (moderate risk) devices require 510(k) clearance from the FDA before they may be legally marketd.
Most Class III (high risk) devices require Premarket Approval (PMA) before they may be legally marketed. A PMA is the most stringent type of premarket submission. Before the FDA approves a PMA, the sponsor must provide valid scientific evidence demonstrating reasonable assurances of safety and effectiveness for the device’s intended use.
De Novo provides a possible route to classify novel devices of low to moderate risk.
The De Novo process provides a pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.
HDE provides a regulatory pathway for class III devices that are intended to benefit patients with rare diseases or conditions.
Information to Consider When Preparing a Premarket Submission
Class II and class III devices must be designed in accordance with Design Controls under the Quality System Regulation (21 CFR 820.30). Most class I devices are not subject to Design Controls.
The types of information and testing necessary to market your device are determined by many factors, including the device classification, principles of operation, technological characteristics, and labeling. Nonclinical testing performed in support of a premarket submission for a medical device should comply with the Good Laboratory Practices (GLPs) in 21 CFR 58.
The FDA encourages the use of FDA-recognized consensus standards in premarket submissions. An integral part of a least-burdensome approach to device review is a reliance upon international consensus standards. Conformance is voluntary, unless a standard is incorporated by reference into regulation (see the Standards Medical Devices Federal Register Documents).
PMAs, HDEs and some 510(k)s and De Novo Classification Requests require clinical evidence. Prior to initiating a clinical study, the study sponsor may need to obtain approval of an Investigational Device Exemption (IDE) by the FDA. The study will also need to be approved by the appropriate Institutional Review Board (IRB). Clinical studies must comply with all applicable IDE regulations and Good Clinical Practices (GCPs).
The labeling for a device must be written according to labeling regulations and included in your premarket submission.
Provision provides registration, clearance, labeling compliance
and even initial importer services.
We will streamline the regulatory processes so that our clients can utilize
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