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US Food and Drug Administration is the legal authority to establish rules and regulations on the use of medical within the United States.

According to Food, Drug, and Cosmetic Act (FD & C) products falling within the scope of medical devices, shall follow one of the options listed below to be released in the United States.

  • Pre-Market Approval (PMA)
  • Pre-Market Notification (PMN)
  • Humanitarian Device Exemption (HDE)

PMN process is generally known as a 510K application and is frequently used by manufacturers wishing to enter the market. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims.

Since 1997 a 510 K application can be made in two ways; “Special” (special) and “Abbreviated” (shortened).

FDA published around 1,700 product codes in order to classify the devices according their intended use.

Classification method is divided into three main groups Class I, II, III and it is also used to describe the procedure, which should be applied to the device before putting it into the US Market.

Manufacturers must conform to the quality management system principles “CFR Title 21-Part 820″. Although this regulation is in line with the ISO 13485: 2016 requirements and some differences in terms of documentation and implementation are existing.

The Food and Drug Administration (FDA or Agency) has identified a list of class I devices that are now exempt from premarket notification requirements, subject to certain limitations. The new exemptions (announced April 2017) are limited in scope, primarily affecting manufacturers of analyte control products.

You can contact us to get detailed information about the process FDA 510K and ” CFR Title-21 Part 820 implementations.

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