MEDICAL DEVICE STANDARDS- Can we shed a little light?
- Monday, 03 April 2017 10:26
- Elaine Duncan
Sometimes identifying the standards that apply to your medical device can seem like looking down a dark tunnel. Is that a light at the end, or a train coming towards you? It could be both!
Long ago and far away, clearance of a US device with FDA did not depend upon conformity to a standard. FDA, believe it or not, didn’t recognize “voluntary” standards and according to regulation, only FDA could issue a “performance” standard. Some years back, the ice broke and certain standards for evaluation of a device became “recognized”. One of the earliest was for the evaluation for biocompatibility (ISO 10993 Part 1), which took the place of the old “tripartite agreement”; and now we have a deluge of standards to consider for any new medical device. Soon the trickle became a roar and regulatory bodies began to see the wisdom of recognizing certain “peer reviewed” standards.
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Transfer a 510(k)?
- Wednesday, 25 February 2015 17:10
- Elaine Duncan
Medical device manufacturers frequently acquire by merger and acquisition a 510(k) from a previous company. The FDA draft guidance issued December 22, 2014 provides information on how to notify FDA of such transfers. http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm427385.pdf This is the FDA’s current thinking on this perplexing issue.
The recipient of the 510(k) assumes the responsibility to verify when a 510(k) changes hands that there has been no significant change of the device since the original 510(k) or when the device was most recently cleared by the FDA. The validity of the 510(k) becomes the responsibility of the purchaser once the sale or acquisition has been made. Due diligence to determine what changes could have been made which might require an updated 510(k) submission is not the subject of this guidance.
In 2012 the FDA modified regulation 21 CFR part 807 to reflect statutory amendments to the FD & C Act brought about by the FDAAA of 2007. These changes launched the Unified Registration and Listing System (known as FURLS) which allowed FDA registration and listing to be tied to the 510(k) number, for those which require a premarket notification. This innovation now allows the FDA to track the “K#” with the registration and listing, and thereby follow the sequence of historical transfers of a particular 510(k).
FDA has not yet implemented this cross-functional database feature but in the future the 510(k) database is supposed to link to FURLS, thus permitting the most up to date registration information to be linked to the 510(k) number. Until this is completed, manual analysis is all that can be accomplished by the general public.
If your company has acquired by acquisition or merger, a premarket notification [510(k)], the notification of FDA that the 510(k) is now owned by your company is as simple as updating the Registration and Listing database. This information must be updated annually, but may be updated at any time. There is no additional fee required to update the annual registration for such 510(k) holder update information. If your company has not previously registered or listed, then there is of course the annual registration and listing fee. Your company would need to have supporting information concerning the 510(k) transfer in the appropriate 510(k) internal file. Be aware, if a company had already registered and listed the same 510(k) in the same calendar year, the database might temporarily allow the same 510(k) number to be shown with two companies. FDA will contact the two companies and seek to resolve the conflict. Therefore it is important if a 510(k) is transferred by sale, the seller should remove the 510(k) number from their listing to avoid confusion. Only one company may “hold” a 510(k) at any given time.
For additional information about registration and listing you can go to http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm318796.htm. Or, contact for help us by way of our website: www.paladinmedical.com.