What is 510 k Clearances Premarket Notification medical devices PMN 510k

Premarket Notification for medical devices – also called PMN or 510(k)

United states Food, Drug and Cosmetic Act in its Section 510(k) says that it is mandatory for a medical device manufacturer to register, and to inform FDA about their intention of marketing a medical device at least 90 days in prior . This process is called as Premarket Notification – also known as PMN or 510(k). US FDA say’s this allows FDA to decide whether the device is equivalent to a device already placed into one of the three classification categories.
Thus, “new” devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified. Specifically, medical device manufacturer is required to submit a premarket notification if he intends to bring in a device into commercial distribution for the first time or reintroduce a device after any minor or major modification which may be related to design, material, chemical composition, energy source, manufacturing process, or intended use and which will significantly change or modified to the extent that its safety or effectiveness might get affected with these changes.

Here are some articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing and regulatory affairs and good manufacturing practice in pharmaceutical industry

Pharmaceutical Validation

Types of validations in pharmaceutical manufacturing

Requirements of documents for validation of sterilisation process

How to investigate OOS out of specification results

Determination of Phenol coeeficient of a disinfectant

Sterility testing

Cleen Room Classification

Time limitations in sterile pharmaceuticals processing

Aspects of validation of manufacturing process in sterile pharmaceuticals

Clinical Trials

Controling Pyrogens in injectable dosage forms

Media fill run process simulation aspects Validation of Aseptic Process and Sterilisation