www.makrocare.com Open in urlscan Pro
74.116.55.61  Public Scan

Form analysis
2 forms found in the DOM

GET https://www.makrocare.com/

<form role="search" method="get" id="searchform" class="searchform" action="https://www.makrocare.com/">
  <div>
    <label class="screen-reader-text" for="s">Search for:</label>
    <input type="text" value="" name="s" id="s">
    <input type="submit" id="searchsubmit" value="Search">
  </div>
</form>

POST #

<form action="#" method="post" class="es_subscription_form es_shortcode_form" id="es_subscription_form_643e7fdb8f5b7" data-source="ig-es">
  <div class="es-field-wrap"><label><input class="es_required_field es_txt_email ig_es_form_field_email" type="email" name="email" value="" placeholder="Enter your email" required="required"></label></div><input type="hidden" name="lists[]"
    value="584cc4c93e8b"><input type="hidden" name="form_id" value="2">
  <input type="hidden" name="es_email_page" value="3947">
  <input type="hidden" name="es_email_page_url" value="https://www.makrocare.com/blog/estar-pilot-by-the-us-fda-and-health-canada/">
  <input type="hidden" name="status" value="Unconfirmed">
  <input type="hidden" name="es-subscribe" id="es-subscribe" value="0b7d5afa4b">
  <label style="position:absolute;top:-99999px;left:-99999px;z-index:-99;"><input type="email" name="es_hp_email" class="es_required_field" tabindex="-1" autocomplete="-1" value=""></label>
  <input type="submit" name="submit" class="es_subscription_form_submit es_submit_button es_textbox_button" id="es_subscription_form_submit_643e7fdb8f5b7" value="Subscribe">
  <span class="es_spinner_image" id="spinner-image"><img alt="Loading" data-src="https://www.makrocare.com/wp-content/plugins/email-subscribers/lite/public/images/spinner.gif" class="lazyload"
      src="data:image/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw=="></span>
</form>

Text Content

We use cookies to offer you better experience. By continuing to use this
website, you consent to the use of cookies in accordance with our Privacy Policy
Accept
Select
LanguageAfrikaansAlbanianArabicArmenianAzerbaijaniBasqueBelarusianBulgarianCatalanCebuanoChinese
(Simplified)Chinese
(Traditional)CroatianCzechDanishDutchEnglishEsperantoEstonianFilipinoFinnishFrenchGalicianGermanGreekHaitian
CreoleHebrewHindiHungarianIcelandicIndonesianIrishItalianJapaneseKoreanLatvianLithuanianMacedonianMalayMalteseNorwegianPersianPolishPortugueseRomanianRussianSerbianSlovakSlovenianSpanishVietnameseWelshYiddish

Powered by Google Übersetzer
Menu
 * Devices
    * Regulatory & QA
       * Strategy
       * Registrations & Dossiers
       * Authorized Rep
       * QMS Management
       * Audits
   
    * CLINICAL
       * CRO Full Service
       * Trial Management
       * Clinical Monitoring
       * CDM / Statistics
   
    * Writing & Scientific
       * CEP/CER
       * PEP/PER
       * PMCF / SSCP
       * Scientific Literature Services
   
    * Labeling Areas
       * Labeling
       * Design
       * UDI Consulting
       * eIFU
   
    * Post Marketing
       * Safety & Vigilance
       * PMS
       * PSUR
   
    * Technical
       * Biocompatibility & BERs
       * Risk Management
       * Usability
   
    * IVDR

 * Biopharma
    * Regulatory
       * Regulatory Strategy
       * Regulatory Intelligence
       * Submission Management
       * Publishing
       * Labeling
       * Life Cycle
       * cdisc SEND
   
    * Clinical
       * Study Management
       * Central Monitoring
       * Late Phase Full service
       * CDM
       * Biostat & SAS Programming
   
    * Writing
       * Medical
       * CMC
   
    * QA GCP Services
       * Clinical Quality Services

 * ConsumerHC
    * Regulatory
       * Regulatory Intelligence
       * Submissions
       * Labeling
       * Life Cycle
   
    * Writing / Reports
       * Clinical
       * CMC
       * Medical Communications

 * Insights
 * About
    * About
       * About Us
       * Management
       * Certifications & Awards
       * Certified Quality
       * CSR
       * Career
       * Contact Us
       * Locations

Home Insights


INSIGHTS

April 4, 2023 eCTD
Share this article:


ESTAR PILOT BY THE US FDA AND HEALTH CANADA

The U.S. Food & Drug Administration (FDA) and Health Canada has announced a
joint pilot program to test the feasibility of using eSTAR to prepare a single
medical device submission to both Health Canada and the FDA for premarket
approval.

The practicability of using eSTAR will be determined by the outcome of 9
participants. Selected participants will use the non-in vitro Diagnostic eSTAR,
which follows the structure of the IMDRF Non-in vitro Diagnostic Device Market
Authorization Table of Contents (nIVD MA ToC).

What is eSTAR?

eSTAR (electronic Submission Template and Resource) an interactive PDF form that
provides assistance to applicants through the process of preparing a
comprehensive medical device submission like 510(k)s and De Novos submitted to
CDRH. It is free and available for voluntary use to all medical device
submitters. The template has the following Features

 * Automation (form construction and autofill)

 * Guided construction for each submission section

 * Integration of multiple resources (guidance documents and databases)

 * Content and structure that match the internal review templates used by Center
   for Devices and Radiological Health (CDRH) and also harmonized with the
   IMDRF’s Non-in vitro Diagnostic Device Market Authorization Table of Contents
   document.

 * Automatic verification feature.

Eligibility factors and participation requirements for the eSTAR pilot

The Eligibility of Device Sponsors to participate in pilot

 * The Sponsor must be ready to submit an eSTAR application for the same medical
   device in Health Canada and US FDA within 6 months of acceptance into the
   pilot.

 * The submission must be for a new or significant change amendment to Class III
   or IV submission of Health Canada

 * A 510(k), De Novo or Pre-market Approval (PMA) original, 180-day, real-time
   or panel track supplement to FDA

 * The Sponsors must complete the eSTAR application

 * The pilot program is NOT applicable to IVD devices, Combination products,
   CBER products or an FDA dual 510(k)/CLIA waiver application.

The limitations for the eSTAR pilot

 * FDA and Health Canada will not accept Regulatory Enrollment Process (REP)
   submission

 * At present eSTAR Submissions are accepted only in English and at later time
   French language will be accepted for submissions to Health Canada only

Requesting participation in the eSTAR pilot

Interested device sponsors can request participation in pilot by sending email
to meddevices-instrumentsmed@hc-sc.gc.ca and eSubPilot@fda.hhs.gov with the
subject line “Request for participation in eSTAR Pilot”. The body of the email
should include:

 * A statement asking to participate

 * Applicant name

 * Contact name and title

 * Device trade name(s)

 * The FDA primary product code, Global Medical Device Nomenclature (GMDN) and
   Preferred Name Code (PNC) of device

 * A statement that the medical device will be submitted within six (6) months
   of acceptance in the eSTAR pilot to both Health Canada (specify if new or
   significant change amendment for a Class III or IV) and the FDA (specify if
   510(k), De Novo or PMA submission [specify further if original, 180-day,
   real-time or a panel track supplement]).

The agencies will respond to the request within three (3) business days.

Preparing a submission using eSTAR

If Accepted into joint eSTAR pilot the agencies will provide an information
package on preparing submission and the process. The agencies recommend that the
eSTAR be under 1 GB in size and any media files like images and videos are need
to be compressed (but viewable). To keep file size down, the agencies request
attachments of similar content to be combined in a pdf and for bookmarks or a
table of contents to be included.

Submitting responses to requests for additional information

If the agencies request additional information in the review of the submission,
the response will be in eSTAR for FDA but for Health Canada it is not within the
scope of the pilot and information should be submitted as per instructions
request from Health Canada.

User fees and Review timeline for eSTAR Pilot

Fees and review timelines are the same as a standard submission.

Health Canada is also running a separate eSTAR pilot for Health Canada-only
submissions, and will select 10 applicants. Many of the requirements mirror the
combined pilot. To learn more about this separate pilot program, the user can
visit the same website linked above for Health Canada.

Note

 * The eSTAR is not currently for use with combination products.

 * As the Health Canada and U.S. Food and Drug Administration’s joint eSTAR
   pilot has reached its total of 9 participants. Requests to participate in the
   pilot are no longer being accepted and the pilot is closed on 27 January 2023

Need more information about our Medical Device Submission? Our expert support
team is here to help. Contact us now to take the next step.

Tags:

510kDeNovoeSTARFDAHealthCanadaMedical Device IndustryMedical Device
SubmissionPMAQMS

<< PREV

Deadline Extended for DMF Type III eCTD Submissions by FDA

Search for:


BROWSE BY TOPIC

 * CER (3)
 * CMC (1)
 * Covid-19 (2)
 * Devices Regulatory Updates (58)
 * eCTD (2)
 * EU MDR (22)
 * IVDR (8)
 * Labeling (6)
 * LCM (2)
 * Pharma Regulatory Updates (8)
 * PMCF (3)
 * Post Marketing (1)
 * Regulatory Automation (1)
 * Risk Management (1)
 * RWD/RWE (1)
 * SaMD (1)
 * UDI (1)

CORPORATE LINKS

 * About Us
 * Certifications & Awards
 * Certified Quality
 * Career
 * Contact Us

KNOWLEDGE CENTER

 * Blog
 * News
 * Events
 * Webinars
 * Thought Leadership

4 Independence Way, Suite 110
Princeton, NJ 08540, USA
Ph: (888) 931 0060

© 2023 MakroCare. All Rights Reserved.

Privacy Policy | Site Map


ORIGINALTEXT


Bessere Übersetzung vorschlagen

--------------------------------------------------------------------------------