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
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
Time limitations in sterile pharmaceuticals processing
Aspects of validation of manufacturing process in sterile pharmaceuticals
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Media fill run process simulation aspects Validation of Aseptic Process and Sterilisation
New Drug Application (NDA) how to make a New Drug Application (NDA) to US FDA
Abbreviated New Drug Application (ANDA) What is ANDA , detaied information about ANDA preparation and submission to US FDA
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Drug applications submission to us fda Over the counter Drugs OTC drugs
BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
Eletronic record in pharmaceutical manufacturing industry
Good manufacturing practice in pharmaceutical industry
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