The FDA has issued a draft guidance document regarding the submission process for any new medical device that sequences DNA of infectious diseases to be able to provide illness diagnosis and assist with treatment. These sequencing devices developed by sponsors will be defined as NGS devices, where NGS represents “Next-Generation Sequencing”. These devices will be able to scan an entire genome of a collected specimen sample to determine the presence of any variations or mutations within the nucleic acid sequence to confirm the identity of the disease/pathogen and can also be used to guide a treatment. These devices should be able to detect genomic information from various specimen samples such as blood, urine, or stool.
Along with this new draft, regulation requirements for these devices will need to be discussed and reviewed. The FDA has determined that these new sequencing devices should be regulated as complete systems and will be defined as Class II medical devices with simple six step one-system procedures. The sample analysis process will depend on various factors such as genome assembly, annotation, test result production, and databases. Some challenges that will go along with the execution of these devices are that each specimen collected will require a different extraction process to be able to separate out the nucleic acids to be sequenced. Also they will require different preparation protocols and different algorithms for bioinformatics analysis.
To ensure validation of the results, sponsors will need an “alternative comparator” to compare the results collected against public microbial genetic information that is present in current databases. An example of a database that could be used is the FDA’s database FDA-ARGOS, which stands for “FDA database for Regulatory Grade microbial Sequences”. This database will provide a “set of validated regulatory-grade microbial genomic sequence entries” to be used for comparison purposes. This guidance document draft clearly outlines the type of data and information that needs to be gathered and submitted when undergoing pre-market submission evaluation of these devices with the FDA.
We hope that this information is helpful to you. If you have any questions about requirements, please feel free to contact Focal Point Research. We are industry leading Medical Device Consultants that you can trust to help guide your company in the right direction.