FDA 510(k) Consulting, FDA 510(k) Consultant

What are FDA Consulting LLC’s FDA Submission Services for medical devices?

Our FDA 510(k) Consultants got an extensive experience in all aspects of the regulatory processes of 510(k), Pre-Sub/Q-Sub, Pre-IDE,IDEs and PMA submissions. Medical devices are classified as Class I, Class II and Class III based on their risk profile. Most of the Class I medical devices are exempt from FDA 510(k) Clearance. Some of the Class I devices requires FDA clearance, all the class II and Class III devices require FDA clearance to market those medical devices in the US. The Class II devices should be cleared by the FDA through a 510(k) Premarket Notification (PMN), or De Novo submission process. The Class III devices require a IDE/Premarket Approval (PMA) submission to get the FDA’s approval to market the device in the US market. These medical devices should be in compliance withQuality System Regulations (QSR) are also known as current good manufacturing practices (CGMP’s) per ISO 13485. cGMP requirements for the medical devices per Section 21 Code of Federal Regulations (CFR) part 820 (21 CFR part 820) and the FDA expects that your Quality System shouldbe in compliance with 21 CFR Part 820, 803 and 807 and your product developed under Design Control 820.30.

How can FDA Consulting LLC assist you to avoid rejection and help with successful submission?

510(k)/De Novo Submission:

The FDA requires that a 510(k) or a De Novo application (must be sent to the FDA in order tolegally market a medical device product in the U.S. The 510(k) must be submitted for certain Class I devices as well as for all Class II devices.

IDE Submission:

A new medical device requires a clinical study as a first step to determine whether your proposed clinical study of the device is deemed to be of “significant or nonsignificant” risk. If the study determined to pose a significant risk, an FDA Investigational Device Exemption (IDE) and Institutional Review Board (IRB) approval will be required before commencing the clinical study. If it’s determined to pose non-significant risk, only an IRB approval is required to proceed with the clinical study.The IDE is required to be approved by the FDA in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application, a Humanitarian Device Exemption (HDE), De Novo or a Premarket Notification [510(k) submission to the FDA. Clinical investigations in the United States must be approved by the FDA prior to conducting a clinical study on an investigational device on human subjects. The IDE rules are spelled out in 21 CFR Part 812.

What’s a “significant risk” in the eyes of the FDA? Here is an example, the implants and devices that sustain human life are obviously substantially risky but the FDA is less clear with regard to all other devices. Getting this determination right the first time is critical to prevent unnecessary delays when initiating a significant risk clinical study.

The FDA can reject your IDE application for many reasons. Some are obvious and preventable such as missing or inaccurate information. Other reasons that include inadequate reporting of prior investigations, poorly conceived investigational plans or incomplete design and manufacturing description. Our FDA consultants are experienced in helping you to navigate these challenges. We can help you to minimize the risk of rejection by crafting a regulatory strategy for your IDE application so that the FDA is less likely to rule that your device risks outweigh its benefits, it is perceived to be ineffective, or your proposed investigation is scientifically unsound.

PMA Submission:

The PMA (Premarket Approval) application must be submitted to the FDA in order to legally market a high risk or Class III medical device in the U.S. The PMA is required for certain Class II devices, where no substantially equivalent medical device currently exists in the market or previously cleared by the FDA, and high risk Class III devices that are not yet approved by the FDA.Our FDA consultants are experienced in helping you to navigate these challenges.

Master Files for devices (MAFs) Submission:

The Master Files for devices (MAFs) also commonly called as Device master file (DMF) is a file that is submitted to the FDA that includes technical, clinical, and safety information about a medical device component or a material. If you are a material or component maker, your customers may request or desire a MAF/DMF from youin order to fulfil the regulatory requirement before they start using your material for manufacturing a medical device.Our FDA consultants are experienced in helping you to navigate these challenges.

How FDA Consultants can help you with your 510(k), De Novo, IDE, PMA, MAF submissions to the FDA?

Our FDA consultant canhelp the clients through the entire documentation, application preparation and submission process.
Application submitted to wrong FDA Center for review,
The FDA has published an exhaustive list of 35-point checklist for the IDE Submission which should be carefully followed. Our FDA Consultant can conduct a gap analysis against the FDA IDE checklist to avoid rejection. One of the way to improve your odds of a successful IDE application is to schedule a pre-submission meeting with FDA. Our FDA consultant has extensive experience working with the FDA and helping medical device client companies plan for a pre-submission meeting to ensure that you get the answers for your critical questions, such as your proposed study design, etc., Our FDA Consultants can:
Schedule a Pre-submission meetings with FDA
Study risk determination
Conduct Early feasibility studies (EFS)
Review and preparation of IDE progress reports
Informed consent form review and planning
Our FDA 510(k) Consultant has an in-depth knowledgeand experience in medical device regulations for FDA compliance and developed strong relationship working with the FDA over the last 30 years. We could recommend you abest regulatory strategy and alsohelp you to submit your applications to FDA. Given our experience, our FDA Consultant can work with you on your submission and to successfully achieve the clearance or approval for your device whether you want end-to-end service from dossier preparation to submissionof your application package to FDA or for us to simply guide you through the regulatory submission process.

Correctly submitting any of these documents to the FDA is both science and art. Unless you have extensive experience in this field, you may encounter some difficulties that you did not anticipate. For 510(k)s we have observed many of the following problems
- Cover letters that are unclear, poorly written, highly technical, contradict application and/or include unsubstantiated claims
- Incorrect classification of a device (e.g. PMA submission that should have been a 510(k)
- Incorrect comparisons of device vs predicate devices
Incorrect product classification/submission (e.g., device, drug or combination product)
- Poor presentation of clinical trial data
- Little understanding of the clinical trial requirements
- Limitations and counter indications that undermine product safety or efficacy
- Advertising material/label that doesn’t match intended use
- Underestimation of the amount of communication and relationship-building that needs to be done with the FDA reviewer
If you supply us with the required information concerning your device, our FDA Consultant can provide you the best regulatory strategy to approach the FDA – either 510(k), De Novo, IDE or PMA, your estimated time for FDA review, and an estimate of the testing and submission costs:
- Intended use of your device
- What legally sold device that you are claiming that your device is substantially equivalent to
- The risks and hazards associated with the use of your device
- The materials your device is made with