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'Exact Medical Manufacturing, - accessdata fda

'Exact Medical Manufacturing, - accessdata fda 2025

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The document is a 510(k) summary for the Exact Medical Manufacturing Equipment Cover-Polyethylene, detailing its intended use as a sterile, single-use protective covering for surgical equipment. It outlines the device's technological characteristics, including material composition and performance testing results, demonstrating substantial equivalence to a predicate device (Kimberly-Clark KC100 Surgical Drapes). The summary includes information on regulatory compliance and non-clinical testing outcomes that confirm the product meets safety and effectiveness standards.

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Is a 510K a premarket submission?

A 510(k) Premarket Notification is required for low to moderate risk medical devices classified as either Class I or Class II and not exempt from 510(k). Companies are unable to market their products to health care providers, patients and other consumers until they are given 510(k) clearance by the FDA.

What does CDRH do?

In keeping with our mission, the Center for Devices and Radiological Health (CDRH) is responsible for protecting and promoting the public health by assuring that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products.

What is the difference between 510K and PMA?

Whats the difference between a 510K vs PMA? 510(k) clearance is authorisation from the FDA to market a medium-risk medical device, while PMA (premarket approval) is required for more high-risk and novel products.

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How to check if something is FDA approved?

Most FDA-approved human drugs and therapeutic biological products are listed in Drugs @ FDA, a searchable database. The database allows you to search by drug name, active ingredient, or application (NDA, ANDA, or BLA) number. Look up the drug in the Orange Book or the biological product in the Purple Book.

Does FDA allow eIFU?

In the US, FDA addresses IFU in 21 CFR Part 801.5. Unfortunately, section 801.5 says nothing about electronic delivery, and there is little formal guidance on their use, compared to the EU regulations. Still, FDA does allow manufacturers to deliver eIFU rather than in paper form.

Is 510K the same as FDA approval?

A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA).

What is the cost of PMA vs 510K?

Annual Establishment Registration Fee: $7,653 Application TypeStandard FeeSmall Business Fee 510(k) $21,760 $5,440 513(g) $6,528 $3,264 PMA, PDP, PMR, BLA $483,560 $120,890 De Novo Classification Request $145,068 $36,2676 more rows Sep 29, 2023

What does PMA mean in FDA approval?

A Premarket Approval (PMA) application is a scientific, regulatory documentation to FDA to demonstrate the safety and effectiveness of the Class III device. There are administrative elements of a PMA application, but good science and scientific writing is a key to the approval of PMA application.

'Exact Medical Manufacturing, - accessdata fda 2025

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