US FDA Approved Materials (which can be used for Medical …
Oct 9, 2011 · Re: US FDA Approved material list? It is okay to say that if the material pass ISO 10993 biocomp tests, it can be used as a material for medical device? Is there any extra requirement beside ISO 10993-4 -"Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood" testing if I am refering to blood contact ...
List of FDA approved Manufacturing facilities (India) - The Elsmar …
Nov 3, 2008 · For the list of FDA approved manufacturing facilities for medical devices, go to the CDRH - Registration and Listing Database and enter INDIA under "Establishment Country". You could further filter using "Establishment Type" to get specific data.
FDA approved Medical Devices for PVD and DLC Coatings
Jan 16, 2017 · - heart valves - St Jude Medical - orthopedic replacement joints - Integra For orthopaedics I would focus on extremities; there have previously been a couple of DLC coated hip joints but they were academic in nature and not really commercialised, I don't think they were in the US/FDA either
US FDA Medical Device Distributor Regulations - The Elsmar Cove …
May 7, 2014 · 1. As a distributor of medical devices, what regulatory information should we consider collecting and retaining in our side. 2. What are the FDA regulations that a medical distributor are concerned with, I mean FDA regulations captures medical distributors. 3.
UL Listing - Do you find UL Listing necessary? Medical Devices
Sep 2, 2009 · If a given device type requires premarket notification or approval and fits into a FDA Product Code for which one of the IEC 60601 "Medical Electrical Equipment" standards is a Recognized Consensus Standard, the FDA does expect that the submitter will have an appropriate conformance stance regarding that standard...either certification/approval ...
Contract Manufacturer Registering with the FDA - Medical Devices …
Mar 28, 2006 · I received a letter mid 2005 that stated if you "1. are engaged in the manufacture, preparation, or processing of a medical device (21 CFR 807.20(a)), AND" "2. introduce the device into comercial distribution, (21 CFR 807.20(c)); then you are required to register the establishement and submit device listing forms FDA 2891 and FDA 2892 respectively.
"Special Process" Validation Requirements (21 CFR Part 820)
May 23, 2014 · Sec. 820.75 Process validation. (a) Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures.
Changing a Medical Device Product Name - Elsmar Cove Quality …
Sep 8, 2010 · The FDA expects to be informed of the intended marketing name of a device during the pre-market approval process, whether PMA or 510(k). The FDA exerts no control over marketing names for exempt devices. Changes to the labeling of PMA devices may require submission of a new 510(k) (probably a Special), or may only require a memo to file.
510(k) Approval Good for Puerto Rico and the U.S. Virgin Islands?
Apr 27, 2010 · Premarket approvals and notifications for the medical devices in USA, including Puerto Rico are under the FDA jurisdiction, so the answer is yes. there is a specific FDA regulation regarding labeling of the devices sold in Puerto Rico: 21 CFR 801.15(c) 33 says that a device is misbranded under section 502(c) of the Act unless:
What the FDA considers a Prescription Device - Decisions and …
Jan 14, 2015 · Re: Prescription Devices - Decisions and Implications Thanks for the replies! The device is class II. In clinical settings, we suggest clinician/therapist supervision, simply because they are in a position to optimize the use (i.e select the best settings based on the patient), as well as aiding those with physical or cognitive difficulties.