Where do I send my 510 K?

Where do I send my 510 K?

A 510(k) submitter should submit one electronic copy or eCopy of its 510(k) to CDRH’s or CBER’s Document Control Center (DCC). The current mailing address for CDRH’s DCC and a link to CBER’s DCC’s mailing address are provided on the eCopy Program for Medical Device Submissions webpage.

Are FDA submissions public?

Upon approval (or denial of approval) of any PMA, FDA will publicly reveal the existence of the PMA and provide a detailed summary of the information submitted to FDA about the safety and effectiveness of the device.

What is the 510k number?

A 510(k) number is a premarket notification number that is required for certain classes of medical devices in the US. Generally, devices that are higher risk require premarket notification to the FDA prior to bringing the devices to market.

How do you write a 510 K submission?

Do be sure your cover letter includes all of the following:

1. Type of 510(k) submission, Abbreviated or Traditional.
2. Your device type in plain terms, i.e., by its common name.
3. 510(k) submitter.
4. At least one contact person, by name, title, and phone number.
5. Your preference for continued confidentiality (21 CFR 807.95)

How do I look up a 510k?

https://www.fda.gov/ https://www.fda.gov/Medical-Devices.

How do you cite 510 K?

Premarket Notification, 510(k) : Regulatory Requirements for Medical Devices. Rockville, Md. : Washington, D.C. :U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health ; For sale by the Supt. of Docs., U.S. G.P.O., 1990.

What is a 510 K submission?

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act). Legally marketed also means that the predicate cannot be one that is in violation of the FD&C Act.

What is a 510 K number?

How do you write a medical device description?

Here is a simple formula for writing product descriptions that follows these parameters….Formula:

1. A simple headline that states the product name.
2. A subhead that touts a product benefit.
3. A few lines of descriptive copy about the product and the challenge it meets.
4. A sharp set of benefit-driven bullet points.