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
In 2001, the Food and Drug Administration (“FDA”) approved HTA for entry into the market under its rigid premarketing approval (“PMA”) process. As HDA was classified under Class III medical device as per MDA, it received the highest level of FDA oversight.
Patient death or serious disability associated with a medication error, and the use or function of a device in patient care in which the device is used or functions other than as intended (AHRQ, 2009).
A: The term Meaningful use is using certified electronic health record (EHR) technology to maintain privacy and secure patient health information, by improving care coordination, population, and public health, help patients and family to be engaged in
Americans must wait up to 19 years after a discovered treatment before they can participate in benefits of a new medication (Philipson & Sun, 2008). The regulatory process drug manufacturers need to endure before releasing potentially life-saving medication is an extremely expensive, time-consuming process. The Center for Drug Evaluation and Research (CDER) is the main department of the Food and Drug Administration (FDA) responsible for the safety of drugs (both prescription and over-the-counter) sold in the United States (Food and Drug Administration, 2011). This department scrutinizes the testing of new drugs and
RA is a progressive disease and while ideally, we could get the patient to go into remission; it is important to make sure that as a care provider we have a plan in mind. The plan that I would keep in mind for this patient would be working on an assistance program for Humira. Often times these programs are available for patient after having failed methotrexate or other non-biologics. I could have the patient speak to an insurance specialist to see if there a better choice in insurance plans. If I am able to get this patient approved for a biologic I would start the patient on this kind of medication. While this is usually a lengthy process I would start the patient on a second DMARD like hydroxychloroquine. This medication can take 2-6 months to start to work though (California Department of Health Care Services, n.d.). I would also keep in mind that a burst of corticosteroid or opioids could be used to try to get the patient over a flare
A review of the records reveals the member to be an adult female with a birth date of 12/07/1969. The member has a diagnosis of osteoarthritis. The member’s treating provider, Peter Townsend, MD recommended the member use the Flector 1.3% patch.
It carefully and efficiently abolishes the emblems of aging by eliminating lines and wrinkles and replacing lost volume in facial tissue and contours. Extensive, scientific tests through clinical trials prove it is expansively safe product to use.
Can John conduct an audit of his company’s quality management system given its present state? Discuss - A quality management system (QMS) is a collection of business processes focused on achieving quality policy and quality objectives to meet customer requirements. It is expressed as the organizational structure, policies,
The original deadline to submit a comment regarding the proposed rule was August 31, 2015, but since has been extended to September 30, 2015. There are several comments I would submit to the FDA about this regulation. It clearly states in the docket that [insert]. My comment is as follows:
In 2009, FDA approved Colcrys (single-ingredient colchicine tablet) for three conditions: (1) Familial Mediterranean fever, (2) acute gout, and (3) prophylaxis of gout flares (DHHS, 2010, p. 60768).
On Thursday, the Food and Drug Administration approved Repatha, the second drug in a large class of powerful cholesterol lowering medicines. Repatha is made by Amgen, and is indicated to only be used by those with heart disease and cannot lower their cholesterol levels with statins and other therapies. This new drug, Repatha, will cost those who use it $14,100 a year.