mdi ConsultantsNew Changes to the FDA’s Device Registration and Listing Database
NEWS FLASH!!!
Guidance for “Transfer of a Premarket Notification (510(k)) Clearance”
In December 2014, we posted an FDA Update on the new draft FDA guidance titled “Transfer of a Premarket Notification (510(k)) Clearance–Questions and Answers”. This guidance provided information on how to notify FDA of the transfer of a premarket notification clearance from one holder to another. Most importantly however, the guidance stated there can only be one current 510(k) holder. While the guidance attempted to explain FDA expectations for industry on how 510(k) number should be used by different parties (manufacturer, specification developer, repacker/relabeler, single use device reprocessor, remanufacturer of a device), it certainly did not cover all industry practices that would be affected by such policy.
We have pointed out our concerns in the December 2014 Update and these were also echoed by many comments sent to FDA by industry in response to the above guidance (Refer to Federal Register Docket # FDA-2014-D-1837).
FDA’s Current Stand and What You Should Know?
Clearly, until the FDA guidance is finalized, industry should not be put in the position to comply before all open concerns are addressed by FDA. Surprisingly, however FDA went ahead and quietly linked its FURLS database with the 510(k) database before providing definitive expectations for industry. According to FDA’s own estimates, there could be as many as 2,000 disputes over 510(k) ownership per year, with an average of 2.3 parties involved – which means more than two parties could be claiming ownership of the same 510(k). In addition, think about a possibility of proprietary contract manufacturing and private labeling arrangements becoming transparent to general public due to unclearly defined policies with the 510(k) number usage.
mdi’s Role:
We want to put all the medical device companies on alert that they should do their own due diligence and internal fact checking not only for their own company registration, but with the companies that they do business with that also must maintain a current medical device registration with FDA. If a contract manufacturer mistakenly lists a device as a manufacturer, the 510k number associated with the device will be revealed to the general public.
mdi Consultants has been providing registration and listing services and are aware of the potential impact on a company’s business if a confidential partnership inadvertently gets revealed on a public database due to a poor understanding of the FDA requirements. We have also been providing strategic advice on 510(k) transfers and ownership to regulated industry clients even before any FDA guidance documents were available. Please feel free to contact us for further guidance on this issue.
? Email us at [email protected] for more information and further guidance about this new development from the FDA and ref: Device Registration and Listing.