PMA or HDE Templates

Introduction

To help industry streamline their process of preparing for premarket approval (PMA) or humanitarian device exemption (HDE) applications for medical devices pursuant to 21 CFR Part 814 (Subpart B and Subpart H) (access to current FDA regulations here), we are offering our following template products in words for your convenience and to save your significant time and efforts during your preparation for PMA or HDE application.

Please be advised that we call our products as “templates” because our Table of Contents are based on what information should be provided pursuant to the applicable regulatory requirements as reflected in our templates under sections/subsections, wherein you may provide your device information (after your own customization as needed) under each section/subsection to address the applicable regulatory requirements in your PMA or HDE applications.  

The following four template products in word are available for your purchase.

Product Description

  • Templates for Premarket Approval (PMA) Applications – Traditional PMA Submissions (Product Name: GCS15-126-PMAT)
    • In a document in word, a customizable Table of Contents (TOC) has been created with sections, wherein you may insert your device information under each section.
    • You may separate four sections into each separate section in a word document for administrative, preclinical, clinical or manufacturing, etc for your convenience as you wish.  
    • You may customize section/subsection titles in accordance with your device information.
    • For compliance to eCopy requirements,  you must separate all sections and save them as independent files in PDFs with the file naming rules pursuant to the FDA’s eCopy guidance. 
  • Templates for PMA Applications – Modular PMA Submissions (Product Name: GCS15-126-PMAM)
    • In four separate documents already available in word, a customizable Table of Contents (TOC) under each document in word has been created with sections (administrative, preclinical, clinical and manufacturing), wherein you may insert your device information under each designated section in documents in word.  
    • It is customizable as your device description permits.
    • For compliance to eCopy requirements, you must separate all sections and save them as independent files with the file naming rules pursuant to the FDA’s eCopy guidance.
  • Templates for Humanitarian Device Exemption (HDE) Applications (Product Name: GCS15-126-HDE)

    • A customizable Table of Contents (TOC) in one document in word has been created with sections, wherein you may insert your information for Administrative, Preclinical, Clinical and Manufacturing.
    • It is customizable so that you may separate four sections into each separate section for administrative, preclinical, clinical or manufacturing.
    • For compliance to eCopy requirements, you must separate all sections and save them as independent files with the file naming rules pursuant to the FDA’s eCopy guidance.

Please note: 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.

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 PMAs or HDEs in an effective, less burdensome manner, REGULATORY DOCTOR developed PMA or HDE templates customizable in accordance with your device information.  

How We Deliver Our Products After Your Purchase

  • We provide the document(s) in word within 72 hours of your purchase by email.  
  • The documents in word are between 20 and 70 pages.  

Please Order Here.

  • GCS15-126-PMAT: $499 
  • GCS15-126-PMAM: $599
  • GCS15-126-HDE: $499 
Share