USA Medical Device Regulations:



In the United States of America (USA), the Food and drug administration (FDA) controls and regulates the market access, entry, import, sales and use of medical devices, In vitro diagnostic (IVD) product and Software as a Medical device (SAMD). USFDA is one of the most regulated market for Medical Devices, IVDs and SAMD with proper, defined and pre-emptive registration pathways.

US FDA Registration




U.S. Medical Device Registration


Medical devices, IVD and SAMD registrations and submissions based on risk assessment and classification are very specific and different for every health authority.

  • Athreva’s medical device experts can handle medical devices and IVD submissions and registrations effectively for United States Food and Drug Administration (USFDA).



Device Classification and Market Entry Support


A market entry for product in USA calls for different routes of device entry. As a first step, manufacturer needs to understand the regulations that exist for the device, which can be determined by knowing the classification and proving substantial equivalence. As per the USFDA, medical devices can be classified into three (3) classes depending on the usage and ‘Indications of use’ of the device.

As per FDA medical devices are classified into 3 risk-based categories:

  • Class I
  • Class II
  • Class III

How Athreva can assist companies to classify their medical device in the USA:

Athreva experts can consult for medical device market entry and can support companies with proper classification for the device intended to be sold in the United States. Here is how we can help:

  • Product classification support with compilation of 513(g) application
  • Gap analysis/ diagnosis of existing technical file and generating a status report for analyzing regulatory requirements
  • Compilation and submission of 510(k) including predicate device identification and proving Substantial Equivalence (SE)
  • Application support for De-novo and PMA for novel devices with FDA
  • Support for pre-submission meetings with FDA for guidance on novel devices market entry

Proper classification of medical devices as per USFDA is important to understand the correct scope of regulatory window that arises from the FDA concerning the route of device entry. This can further reduce the loop of regulatory submissions, approval and expenses.


QMS Compliance Services


Implementing and maintaining a quality management system (QMS) is a pivotal part of regulatory compliance for most markets around the world. Athreva has expertise to establish, maintain, and remediate your QMS requirements.

As a part of Athreva’s QMS compliance services, we offer

  • Gap analysis to identify the applicable standards
  • FDA QSR 21 CFR Part 820 consultation support for medical device and IVDs
  • Support with Quality system ISO 13485 for medical device manufacturer
  • Support for audit co-ordination and query response for ISO 13485
  • Compliance with design control protocols

Labeling, Artwork and Promotional Material Creation and Review


Athreva’s state-of-the-art in-house Artwork studio and printing competency can assist medical device manufacturers with their labeling, artwork, printing and packaging requirements which are a major cause of device recalls. One such solution is to ensure regulatory compliance of your label and promotional material according to the requirements as per FDA. Inconsistent labels produced due to a lack of defined label creation process have far-reaching implications – from concept finalization to final product sales. Dispensing with these issues need a fresh approach and guiding hands of a domain expert.

Athreva assists medical device companies in achieving end to end regulatory assistance and compliance with quality. We cater to the entire life cycle of the medical device value chain providing labeling and artwork solution, right from comprehensive artwork check, and regional language support etc.

Our labeling services includes following:

  • Regulatory support for labeling design as per ISO 15223, FDA labeling requirements
  • Gap analysis of the labels to meet regulatory requirements
  • Advise on promotional material design as per regulatory requirements

Our Artwork Studio and printing services include following

  • Creation of artworks as per FDA requirement
  • Promotional artwork creations for print as well as web platforms.
  • Proofreading of artworks
  • Printing of artworks in packaging material.

Regulatory Strategy and Approach


Acquiring the right regulatory strategy for medical device in US market is a complex process for successful product development, registration, and commercialization. It entails a lot of efforts from cross-functional teams to develop the device from conception to submission along with proper understanding of regulatory strategy needs. Athreva can support in developing appropriate and effective regulatory strategies.

  • Classification strategy for borderline products
  • Advise for combinational product submission
  • Technical analysis of the product changes and categorization to critical and non-critical changes
  • Update of technical file with the changes for submission to FDA
  • Regulatory advice on change implementation with supporting documentation

US Agent Services


A manufacturer based in the United States and/or any part of the globe intending to manufacture, prepare for market access, entry, import, sale or distribute medical device or IVD must identify a local Agent based in USA. Athreva can expertly handle FDA interactions on your behalf and indulge with responsibilities like: 

  • Legal representation in USA with the FDA
  • Providing a registered correspondence address in the US
  • Incident reporting and complaint handling as per the manufacturer’s need
  • Support for technical file submissions to the FDA
  • Aiding the FDA in scheduling audits
  • Interaction with the agency for submissions, queries, and additional information requests


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