Overview of FDA Premarket Planning
Navigating the regulatory approval process can be difficult for novel technologies and combination products. QualityHub can determine how your product is regulated by the FDA and develop an effective strategy for product approval and commercialization.
Our team can:
- Determine product classification and the regulatory pathway for marketing approval.
- Develop a regulatory submission strategy and timeline.
- Ensure the right documentation is developed to support safety and effectiveness claims in commercial marketing applications.
- Identify substantially equivalent medical devices for the purpose of submitting a 510(k) premarket notification.
- Manage pre-submission communication with FDA to get early input on the regulation of a client’s unique product.
- Assist with FDA communication through the Q-Submission (Q-Sub) program.
- Determine if a product change should be submitted to FDA for approval prior to marketing.
QualityHub’s regulatory professionals have experience in developing and submitting NDAs, PMAs, BLAs, 510(k)s, and De Novo applications. We can help prepare applications or provide a review of client-prepared documentation prior to submission to identify potential risks or concerns early.
QualityHub can also assist in preparing responses to questions submitted by regulators following their initial review of an application. Our experienced regulatory professionals understand the FDA's expectation for demonstrating safety and effectiveness. We can help ensure your submissions are supported with objective evidence that is well organized and presented with clarity and readability in mind.
Medical device design control regulations require design reviews that include an independent reviewer (a reviewer not directly involved in the development phase under review). For small startup companies, identifying an independent reviewer can be difficult when everyone in the company may be actively working on the project.
QualityHub has quality and engineering professionals with experience in design, development, validation and commercialization of a wide range of medical products and technologies. Our professionals can participate in design reviews, serving as an independent review party and providing valuable input to the review process.
QualityHub’s team has helped many clients develop and organize their design history files and technical files. We can provide engineers, technical writers and project managers that can integrate with your design team to ensure that the right documentation is being developed in realtime as the project moves from the planning phase through development, verification, validation, and design transfer.
QualityHub can also provide an independent review of the DHF and technical files upon completion of each development phase to ensure appropriate documents and records have been compiled and indexed per the design plan.
Concurrent with this review, we can assist with the completion of the design traceability matrix that demonstrates design outputs meet the design input requirements with reference to the appropriate specifications, verifications and validations.
Human factors/usability engineering examines and optimizes the interaction between medical devices and the people that use them. Human factors engineering is central to ensuring device safety and effectiveness for the intended user population. Our quality engineers can help integrate the principles of human factors engineering into your product development program, to facilitate alignment with the FDA’s expectations in the guidance for, “Applying Human Factors and Usability Engineering to Medical Devices."
Examples of ways our team can help include:
- Establish appropriate procedures for the integration of human factors in product development.
- Perform and document a detailed Task Analysis.
- Assist with usability risk assessments (i.e. Fault-Tree analysis & Usability Failure Modes Effects analysis).
- Support the development of protocols and reports for human-factors studies (i.e. formative studies, summative studies and HF validation studies).