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What Is RHA 3 And Rha 4?

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Regulatory Pathway Identification RHA® 2, RHA® 3, and RHA® 4 are injections which are indicated to treat moderate to severe dynamic facial wrinkles and folds for adult population aging 22 years or more. RHA® 2 and RHA® 3 are indicated for mid-to-deep dermis whereas RHA® 4 is used for deep dermis to superficial subcutaneous tissue. RHA® 2, RHA® 3, and RHA® 4 are injections used for cure or treatment which affects the structure of the human body. Hence, as per the definition of FDA they are classified as medical devices. https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051512.htm Combination device RHA® 2, RHA® 3 and RHA® 4 contains 23 mg/g of sodium Hyaluronic Acid (NaHA) which is derived from…show more content…
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170002 Submission Classification RHA® 2, RHA® 3 and RHA® 4 are elevated risk devise since they are pre-filled syringed to be directly used by the end user and hence classified as Class III device. This makes the product most suitable for a PMA application. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170002 Quality Management System Quality Management System (QMS) as mentioned in 21 CFR 820 is to be adapted. The QMS should meet the criteria as available in FDA Quality System Regulation. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820 Pre-Submission (Pre-sub) meeting request As per the guidance issued on September 29, 2017, “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff” that an applicant can approach FDA and request a feedback related to a planned medical device Investigational Device Exemption (IDE) or a Premarket Approval (PMA) As per the Medical Device User Fee Amendments of 2017 (MDUFA IV), it has been agreed by the agency and the industry that the Pre-submission Program will be modified with changes related to Pre-Sub meeting request and the timeframe within which the FDAA will provide its advice or comments on the same. The Pre-sub and other type of FDA feedback are now
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