Get the free 510 (K) SUMMARY - accessdata fda

A summary document submitted for premarket notification that outlines the safety and effectiveness of Tangshan Pufa Plastic Products' Synthetic Vinyl Patient Examination Gloves, including compliance

How to fill out 510 k summary

How to fill out 510 (K) SUMMARY

1. Begin by gathering all necessary information regarding the medical device being submitted.
2. Use the FDA's recommended guidelines to identify the appropriate predicate device.
3. Fill out the cover sheet with the necessary identification information.
4. Describe the device in detail, including its intended use and technological characteristics.
5. Provide a summary of the substantial equivalence to the predicate device.
6. Include any relevant safety and effectiveness data.
7. Document any labeling and packaging information.
8. Review and double-check all sections for completeness and accuracy before submitting.

Who needs 510 (K) SUMMARY?

1. Manufacturers of medical devices seeking FDA clearance to market a new device that is substantially equivalent to an existing one.
2. Companies looking to modify an existing device that necessitates regulatory approval.
3. Healthcare providers and professionals involved in the design and development of new medical devices.

People Also Ask about

What is the content of a special 510k?

Most 510(k)s will include some type of performance data. The extent of performance data will depend on the complexity of the device and its intended use and indications. Performance data should be provided to help demonstrate SE of your device to one or more legally marketed devices (predicate device).

What is the 510K approval process?

The FDA receives 510(k) application. The FDA sends an Acknowledgement Letter or a Hold Letter if there are issues with user fees and/or eCopy. The FDA conducts an Acceptance Review. FDA informs the applicant if 510(k) is accepted for Substantive Review or placed on RTA Hold.

What is the 510k process?

The 510(k) regulatory pathway is a submission process that medical device manufacturers use to get clearance from the FDA to market an eligible product in the U.S. Under the 510(k) pathway, a medical device manufacturer submits a premarket notification to the FDA, which includes information about the device's intended

How long does it take to get a 510 K approval?

It is worth noting that the most common time window to clearance (median) is 80-90 days, followed very closely by 50-60 days.

What is the 501k process?

The FDA 510(k) Program is occasionally referred to as premarket notification. It allows a new medical device to gain FDA approval by establishing a set of similarities to a current medical device that is already on the market.

How long does 501k approval take?

Generally, 510(k) applicants can expect submission acceptance review decisions within 15 calendar days; substantive review decisions within 60 days; and final decisions within 90 days. Applicants with outstanding review issues will be notified within 100 days.

What is the 510 K process?

The FDA's 510(k) submission process is, in a nutshell, a clearance process which every company wanting to bring a medium-risk medical device to the American market must pass through. Almost half of all medical devices used in the United States every day will have passed through the 510(k) route.

What is the 510K decision making process?

It is worth noting that the most common time window to clearance (median) is 80-90 days, followed very closely by 50-60 days.

What are the requirements for 510k clearance?

The FDA 510k submission requirements include extensive technical documentation such as proposed labeling, sterilization and shelf life data, biocompatibility research, animal, clinical and bench performance testing and other technical evidence needed to establish substantial equivalence and receive FDA 510k clearance.

What is the 5 10k approval process?

The 510(k) regulatory pathway is a submission process that medical device manufacturers use to get clearance from the FDA to market an eligible product in the U.S. Under the 510(k) pathway, a medical device manufacturer submits a premarket notification to the FDA, which includes information about the device's intended

For pdfFiller’s FAQs

What is 510 (K) SUMMARY?

The 510(k) Summary is a document submitted to the FDA that outlines the intended use, safety, and effectiveness of a medical device, establishing its equivalence to a legally marketed device.

Who is required to file 510 (K) SUMMARY?

Manufacturers or sponsors of medical devices that intend to market a product in the United States and believe their device is substantially equivalent to an already marketed device are required to file a 510(k) Summary.

How to fill out 510 (K) SUMMARY?

To fill out a 510(k) Summary, manufacturers must provide information such as the device description, comparison to the predicate device, intended use, labeling, and performance data demonstrating substantial equivalence.

What is the purpose of 510 (K) SUMMARY?

The purpose of the 510(k) Summary is to provide the FDA with enough information to determine whether the new device is substantially equivalent to a legally marketed device, ensuring its safety and effectiveness for consumer use.

What information must be reported on 510 (K) SUMMARY?

The 510(k) Summary must report device identification, intended use, detailed description of the device, performance testing results, comparison to predicate devices, and labeling information, among other relevant details.