Fee waivers and exemptions. Under the new law, a fee will not be charged for certain submissions:
| Table 2 — Fee Exemptions and Waivers (No Fee for These) | | Category | Exemption or Waiver | | HDE | Exempt from any fee. | | BLA for a product licensed for further manufacturing use only | Exempt from any fee. | | First premarket application (PMA, PDP, BLA, or premarket report) from a small business | One-time waiver of the fee that would otherwise apply. | | Third-party 510(k) | Exempt from any FDA fee; however, the third-party may charge a fee for its review. | | Any application for a device intended solely for pediatric use. | Exempt from any fee. If an applicant obtains an exemption under this provision, and later submits a supplement for adult use, that supplement is subject to the fee then in effect for an original premarket application. | | Any application from a State or Federal Government entity. | Exempt from any fee unless the device is to be distributed commercially. |
Reduced fees are available to protect small businesses. An applicant that qualifies as a small business is eligible for reduced fees. Small business fees are significantly less than the fees that would otherwise be assessed. | 
