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How Fast Can I Get My 510(k) Cleared, and Can It Be Expedited?
TPRG’s FDA-accredited third-party review service offers expedited 510(k) clearance, with device approvals in 30 to 45 days. This fast-track process cuts the standard FDA 510(k) submission timeline by over 100 days, helping your medical device reach the market quickly.
Why Should I Choose TPRG Over the Traditional FDA Process?
TPRG’s third-party 510(k) review ensures faster clearance times and lower costs. With over 100 years of regulatory experience, TPRG is a recognized industry expert and is accredited to fast-track your device for quicker market clearance.
What Does a 510(k) Mean?
A 510(k) submission demonstrates that your device is safe, effective, and substantially equivalent to one already on the US market. TPRG specializes in the review of 510(k) submissions, providing you with efficient FDA clearance.
The Third Party Review Group is the expert in 510K TPR clearances. For immediate assistance, contact Catherine Read, VP Global Sales at 408-838-5325 or email at [email protected]. You can also call our offices direct at 973-232-0811.
What Are the Requirements for an FDA 510(k) Clearance?
To obtain 510(k) clearance, your device must be substantially equivalent to a legally marketed device (predicate device). All submissions must use the eSTAR format for streamlined reviews. To expedite this process simply put to obtain an FDA 510(k) clearance, a medical device must demonstrate that it is substantially equivalent to a legally marketed device. That device is called a predicate device. The electronic Submission Template And Resource (eSTAR) is an interactive PDF form that guides applicants through the process of preparing a medical device submission. All 510(k) submissions must use this format.
How Long Does It Take to Obtain FDA 510(k) Clearance?
Typically, the FDA reviews 510(k) submissions within 90-120 days, but delays can occur. TPRG’s Third Party Review (TPR) program offers an expedited path, reducing this timeline to as little as 30 days.
What Can I Do to Speed Up My FDA 510(k) Clearance?
To expedite your 510(k) clearance, engage TPRG early in your device development process to confirm eligibility for the Third Party Review (TPR) program. This early involvement helps us determine the best TPR pathway for your device. If needed, you can accelerate the process with a 24-hour administrative review and take advantage of weekends and holidays, saving valuable time. By working with TPRG early, we can reserve time on our calendar and adjust review timing to meet your specific needs.
How Do I Submit a 510(k) Through the TPR Program?
Yes. TPRG is honored to be accredited by the FDA to provide expedited reviews under the TPR program. Your 510K clearance can be obtained in as little as 30 days.
How Do I Submit a 510(k) Through the TPR Program?
- Determine Eligibility: Contact TPRG to check if your device qualifies for the FDA’s Third Party Review (TPR) program.
- Schedule Your Submission: Coordinate your timeline with TPRG to secure your place.
- Submit Using eSTAR: Upload your 510(k) submission via TPRG’s secure database for expedited review.
Am I Required to Pay the FDA MDUFA Fee When Participating in the TPR Program?
No. By using TPRG’s FDA TPR program, you are not required to pay the MDUFA fee, making our service more cost-effective than the traditional route.
즉각적인 도움이 필요하면 Catherine Read, 408-838-5325 글로벌 영업 부사장에게 문의하거나 [email protected] 로 이메일을 보내십시오. 973-232-0811로 직접 저희 사무실로 전화하실 수도 있습니다.
Should I Have a Presubmission Meeting with the FDA?
Yes, a presubmission meeting is highly beneficial if you need guidance on your predicate selection or device development plan. While TPRG doesn’t participate directly in these meetings, the feedback provided will aid in your 510(k) submission, streamlining the review process.
When Should I Contact the Third Party Reviewer?
As soon as you identify the predicate device and product code for your 510(k) submission, it’s important to contact TPRG. At this stage, we can confirm your eligibility for the FDA Third Party Review (TPR) program, which offers expedited 510(k) clearance. This fast-track process can greatly benefit your strategic planning and revenue forecasting. Engaging TPRG early ensures a smoother submission process, helping you achieve FDA clearance efficiently and reach your market goals without unnecessary delays.
How Do You Protect Our Intended Use in Competitors’ Applications? Or other confidential information?
As a third-party review agency, our role is to evaluate submissions impartially and independently. We do not prepare submissions nor reuse any specifics, such as intended use statements, from one application in another. Each client’s submission is treated as unique and confidential. Our team adheres strictly to non-disclosure agreements and ethical guidelines to ensure that all information remains secure and is handled with the utmost integrity. Rest assured, safeguarding your proprietary information is a top priority for us.
Is the Intended Use in a 510(k) Public Information?
The FDA prioritizes transparency and makes 510(k) clearance details, including the “Intended Use,” publicly available. Manufacturers must submit a 510(k) Summary or Statement for inclusion in the FDA’s accessible 510(k) database. While some information can remain confidential, “Intended Use” is generally disclosed to meet regulatory standards and ensure public health safety. If you’re concerned about competitive impacts, consulting a regulatory expert or legal counsel can help you craft your “Intended Use” statement to comply with FDA guidelines while protecting your business interests.
타사 검토 그룹은 요구 사항과 지침을 이해하는 경험을 가지고 있으며 매우 간단하고 효율적인 프로세스를 만들었습니다. 우리는 당신이 당신의 사업을 앞으로 나아갈 수 있도록 빨리 지워집니다. 오늘 제3자 리뷰 그룹에 문의하십시오.
즉각적인 도움이 필요하면 Catherine Read, 408-838-5325 글로벌 영업 부사장에게 문의하거나 [email protected] 로 이메일을 보내십시오. 973-232-0811로 직접 저희 사무실로 전화하실 수도 있습니다.