In 1938, congress passed a set of laws giving authority to the U.S. Food and Drug Administration FDA application to oversee the safety of food, drugs, and cosmetics. Section 510(k) requires Medical Device manufacturers to register and notify FDA, at least 90 days in advance, of their intent to market a medical device in the USA. This is called the Premarket Notification (PMA). This notification allows the FDA to determine if the device has already been classified within any of the three categories. The 510(k) notification involves devices that are “substantially equivalent” or a “predicate” to legally marketed medical devices in the United States. Devices that are significantly different, in terms of design, material, chemical composition, energy source, manufacturing process, or intended use, go through premarket approval, or PMA process. Some new devices are classified as Class III by the FDA clearly because there is no predicate device available. However, Section 513(f) of the Food, Drugs and Cosmetic Act requires the sponsor of a novel product to submit a de novo application for the possible reclassification of the novel Class III product to a Class I or Class II device, removing the requirement for expensive and time-consuming PMA. Pre-Submissions (Pre-Subs) are often processed and published, with respect to PMAs and de novo applications, in order to be in accordance with the FDA on the regulatory approach and quality of the applications.
E & E Medicals and Consulting helps during the process of submitting applications for class I, II, III medical devices at any stages of the product development. Our team of qualified experts will successfully prepare and submit FDA medical device regulatory documents for the U.S and international clients. These applications include:
510(k) Premarket Notifications
E & E Medicals and Consulting provides answers to related questions:
- Which classifications (Class I, II, and III) do we require an FDA 510(k)?
- How many stages consist of the 510(k) application process?
A class I, II, and III device intended for human use, for which a Premarket Approval FDA application (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and does not exceed the limitations of exemptions in .9 of the device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9). Technically, under the 510(k) process, the FDA does not “approve” medical devices and IVDs; the FDA issues a “clearance” or “Approval” for sale in the United States. Normally, the FDA shall be subject to a provision of 510(k), should manufacturers intend to sell the Class II Medical Devices and some required Class I and III devices or IVDs on the US market. A pre-market 510(k) approval is also required for already approved medical devices (Predicate) if the manufacturer(s) modifies the technology or changed the intent of device usage in a way that significantly affects patient safety or device performance.
Our services includes:
- Identification of device class, product code and regulation number
- Identification of predicate device
- Identification of test standards
- Identification of 510k test requirements
- Identification testing or certification lab
- medical device label review
- Preparation of 510k documents
- Submission of 510k documents to FDA
- Provide US Agent service for 510 k
- Communicate to FDA on behalf of our client
- Prepare clarifications to questions from FDA
- Assistance in transfer of 510k review fees to FDA
- Notify the new 510 k number
- Assistance in Establishment registration with FDA
- Assistance in Device Listing with FDA
Our US FDA 510(k) Submissions Strategy
We follow a two-stage approach to ensure a successful 510(k) application. This strategy is cost-efficient for many customers, and the risk of a 510(k) FDA clearance not being issued is significantly reduced.
The proposed use and design of a device helps us identify the appropriate FDA product code and regulation number that can indicate FDA device-specific guidance and standards.
- To determine whether your device meets the criteria of substantive equivalence for your product, we evaluate similar devices (predictive devices) with FDA 510(k) clearances.
- A list of the documentation and information required for the FDA 510(k) submission is provided for each specific product.
- To determine its suitability for 510(k) FDA submission, a regulatory consultant will review the details and prepare a detailed gap analysis report, which includes any incomplete or missing information for a full 510(k) submission.
- We shall help you close the identified gaps and provide other valuable information.
E & E Medicals and Consulting will prepare final 510(k) presentation when all the required documents and information have been received. We’re going to:
- Prepare a technical comparison of your medical device to the predicate device(s).
- Prepare all 21 sections of the FDA 510(k) application.
- Submit the hard copy and eCopy of the 510(k) to the CDRH division within the FDA and be the correspondent for further communications with the FDA.
- Coordinate payment of FDA 510(k) submission fees on your behalf.
- Send a hard copy and an eCopy of 510(k) to the CDRH division.
- Arrange all submission fee payments to the FDA.
- Contact you immediately on all FDA information received after the 510(k) filing and support them, if necessary, to answer any additional requests for information.
Many pharmaceutical researchers believe that IND and ANDA FDA application submissions are not initially approved most of the time. Our pharmaceutical consultants are expert ANDA Consultants, NDA Consultants and IND Consultants provide our customers with the best possible service. They have the knowledge and experience to increase the chances of receiving initial approval. Our FDA consultants prepare all FDA drug approvals, including:
In comparison to other pharmaceutical consultancies, our experienced accredited regulators have a strong relationship with FDA officials. Let your application be completed by our professional staff or direct you through the FDA application process. The FDA does not only need the safety and efficacy of pre-clinical and clinical data from many pharmaceutical research firms but also investigates the production processes to make sure cGMP standards are met. Our FDA drug consultants will assist you with a well-developed plan for your product application strategy. E & E Medicals and Consulting offers our pharmaceutical customers the following services: