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K )1 3o,3 - accessdata fda

K )1 3o,3 - accessdata fda 2025

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The document provides a summary of safety and effectiveness for the Unicompartmental and Bicompartmental Knee System Instruments developed by Smith & Nephew, Inc. It outlines the device's classification, indications for use, and substantial equivalence to predicate devices. The instruments are designed to assist in the implantation of knee systems for conditions such as osteoarthritis, traumatic arthritis, and post-traumatic arthritis. The document also includes regulatory information from the FDA regarding the marketing of these devices.

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What is a third party 510k review?

Overview. The 510(k) Third Party Review Program provides medical device manufacturers with a voluntary alternative review process, in which accredited Third Party Review Organizations (3P510k Review Organizations) are allowed to review certain low-to-moderate risk medical devices.

What are the requirements for FDA IND?

Filing an IND requires completion of 3 sets of forms: 1 detailing the study (FDA Form 1571), 1 providing information about the investigator and study site (FDA Form 1572), and 1 certifying that the study is registered in the national database of clinical trials (FDA Form 3674).

What is Phase 3 FDA drug approval?

Phase III. Phase III studies are conducted at multiple centers with several hundred to several thousand patients for whom the drug is intended. Massive testing of a drug provides continued generation of data on a drugs safety and efficacy. As in Phase II, most Phase III studies are randomized and blinded.

What is the FDA definition of OTC?

Over-the-counter medicine is also known as OTC or nonprescription medicine. All these terms refer to medicine that you can buy without a prescription. They are safe and effective when you follow the directions on the label and as directed by your health care professional.

What is the FDA CRF?

Code of Federal Regulations (CFR) FDAs legal authority to regulate both medical devices and electronic radiation-emitting products is the Federal Food Drug Cosmetic Act (FDC Act). The FDC Act contains provisions, that is, regulatory requirements, that define FDAs level of control over these products.

What is the continued access protocol FDA?

Continued Access (Extended Investigation) of an Unapproved Medical Device. FDA may allow continued enrollment of subjects after the clinical trial under an IDE has been completed to allow access to the investigational medical device while the marketing application is being prepared by the sponsor or reviewed by FDA.

What is continued access to investigational drugs?

Continued access can be defined as the continued provision of the investigational medicine or continued maintenance of the investigational significant risk implanted device for any clinical trial participant after participation in the trial.

Can class III devices go through 510k?

Appropriately, the PMA is the most intensive type of device marketing application required by the FDA. As you can see in our decision tree above, some FDA Class 3 devices may qualify for the 510(k) route if you can find a suitable predicate marketed before the Medical Device Amendments of 1976.

K )1 3o,3 - accessdata fda 2025

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