510(k) is an FDA application for medical devices that don't have a lot of risk. It is basically a shortcut to avoid going through the whole approval process. It was originally so that devices prior 1976 could get re-approved if they got updated.

513g submission -- is this a device? What kind of device?

Classes:

• Class I - gloves
• Class II - 510ks. medium risk, MRI, etc.
• Class III - high risk, drug alluding stents, ICDs, etc.
• De Novo: done well elsewhere, not risky, can be downgraded immediately
• Humanitarian Device Exception - develop something for a disease where there is only 4000 patients. Less stringent.

90% of 510k submission with be reviewed in 90 days + days it takes you to answer the FDA

FDA checks for

• same use. If different, then not 510k.
• same technology. If tech different:
  • new tech raises the same sorts of questions
  • data supports that the device is just as safe and effective.

510k needs

• intended use
• technology
• performance data

medica device database

• code of federal regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
• premarket notification (510k) database: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm