FDA 510(k) Templates

510k510(k) Templates Are Customizable for Traditional, Abbreviated, and Special 510(k)s and Are Made Compliant with the e-Copy and RTA Policy Requirements

510(k) Templates

  • Templates for traditional, abbreviated and special 510(k)s
  • Documents in word
  • Available by section by section
  • Customizable for your device types
  • Cover letter included addressing RTA policy, effective as of October 1, 2015
  • eCopy ready format
  • RTA items – made easy to address
  • Support available while using our 510(k) templates
  • GREAT TIME SAVER!
  • Delivered by email within 24 hours of purchase

Statutory Requirements and Background

Pursuant to Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), added by section 1136 of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144), the submission of an eCopy is required.  For FDA guidance document (“eCopy”), issued 12/31/2012, click here.

On 12/31/2012, FDA issued Refuse to Accept Policy (“RTA Policy“) and then updated on August 4, 2015, which is available at Guidance Document for 510(k)s. In the guidance document, FDA explains the procedures and criteria FDA intends to use in assessing whether a 510(k) submission meets a minimum threshold of acceptability and should be accepted for substantive review.

To meet the requirements of both the eCopy and RTA policy for 510(k)s, it takes your significant time and efforts. The templates will significantly save your precious time and efforts.

To help medical device industry prepare for 510(k)s in an effective, less burdensome manner, REGULATORY DOCTOR developed 510(k) templates customizable for 510(k) types (traditional, abbreviated, and/or special).

Purchase Options

Traditional 510(k) Templates: $299 

Abbreviated 510(k) Templates: $259 

Special 510(k) Templates: $219 

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