Beginners Guide: FDA Regulations for Medical Devices & IVDs

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So, where is the newcomer to FDA regulations and guidelines to begin?

There are a mesmerising series of FDA Guidelines regarding the manufacture, import and/or distribution of Medical Devices (incl. in vitro Devices - IVDs) on the US Market. And nowadays there also seems to be a continuous stream of new and draft guidelines being published.

So, where is the newcomer to FDA regulation and guidelines to begin?

The FDA web site is totally comprehensive but can be bewildering.  Whether your interest is based on an intention to ...

a) market a device in the US,

b) seeking additional guidance for product marketed in the EU Regulatory Area (with the push for global harmonization in medical devices the FDA information is generally applicable in Europe),

c) development and deployment of MDSAP, or

you want to develop and implement an easily expandable MDMS,

we suggest two entry points for your information search.

1. Basic FDA Regulation for Medical DevicesISO 13485 Implementation

FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States.

In addition, CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and colour televisions.

The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are:

  • Establishment registration,
  • Medical Device Listing,
  • Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA),
  • Investigational Device Exemption (IDE) for clinical studies
  • Quality System (QS) regulation,
  • Labelling requirements, and
  • Medical Device Reporting (MDR)

An excellent introduction to these seven topics can be found at Overview of Device Regulation.

2. Learn How the Regulations are Applied

The FDA’s CDRH also provides training in the regulations and associated guidelines through CDRH Learn.  CDRH Learn uses e-learning methods to describe many aspects of medical device and radiation emitting product regulations, covering both pre-market and post-market topics.  

Recent offerings include…

  • Start Here/The Basics! - Registration and Listing
  • How to Study and Market Your Device - 510k, de novo, IDE, PMA, HUD/HDE, Q-Submissions, Standards, Classification
  • Postmarket Activities - Quality System, Exporting, Device Recalls, MDR, Inspection - Global Harmonization (MDSAP)
  • Unique Device Identification (UDI) System
  • Specialty Technical Topics - in vitro Devices (IVDs), Digital Health, Human Factors, Home Use, Neurological Devices, PPE
  • Radiation-Emitting Products
  • 510(k) Third Party Review Program (for Third Party Review Organizations
  • Industry Basics Workshop Series

 Click here to be taken to the CDRH Learn web site.

ISO 13485 Course

Note: Originally published in Jan 2017, reviewed and updated in Oct 2020.

Written by Dr John FitzGerald

Director and founder of deGRANDSON Global. After 15 years in the manufacturing industry, John has spent the past 25 years training, consulting and auditing ISO 9001 and other management systems.

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