Last Updated on January 20, 2024 by BIOMEDRIC

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services, which is responsible for regulating food and medical products that are manufactured, imported, or marketed in the U.S. The FDA’s primary purpose is to ensure that these items are safe and effective since public health falls under this branch of government’s jurisdiction. The FDA Regulations for Medical Devices are part of this goal of the FDA.

The FDA oversees medical devices both before they enter the market as well as when they are on it – from surgical implants to hearing aids – ensuring that they do not cause harm to consumers or providers alike through a bevy of safety checks designed to monitor everything including seals and labels.

Medical devices create one of the most challenging groups for the FDA to regulate due to the wide range of these devices, including high-risk products such as pacemakers, artificial heart valves, breast implants, hip replacements, etc. The FDA has taken on this challenge by regulating medical devices under a different set of rules, referred to as the “premarket” and “postmarket” requirements.

Premarket Requirements

Premarket requirements entail all of the measures that must be taken prior to introducing a new device into U.S. commerce. The manufacturers of these devices must check their products for many safety issues, including:

• The design and performance of the devices have been evaluated by experts, and that the devices have been manufactured in accordance with the design specifications, including adequate tolerances.

• The procedures used in manufacturing the device conform to Current Good Manufacturing Practices (cGMP) which are outlined by various regulatory agencies. This means that all aspects of the manufacture meet and exceed FDA standards. Devices are also tested for effectiveness after manufacture to ensure that they are safe and effective for their intended use.

• Any relevant premarket information that the manufacturer has, such as animal studies and clinical trials, is reviewed and declared as suitable for human use.

• The device is certified by the FDA’s Center for Devices and Radiological Health (CDRH) to meet all relevant standards related to safety.

Postmarket Requirements

Postmarket requirements entail all of the measures that must be taken after a medical device has been introduced into U.S. commerce. The manufacturers of these devices must check their products on a regular basis for any safety issues, which include:

• The device must ensure that it has been manufactured in accordance with the previously stated manufacturing requirements. The manufacturer must submit any cGMP violations to the FDA for inspection and then fix them if they are found to still be applicable.

• Devices must be maintained in accordance with the original design specifications through regular inspections.

• All changes in design or performance of the device that affects its safety must be approved by the FDA prior to introduction. (e.g. a more effective new design for a hip replacement). If the device is altered, then it must also meet new requirements based on this alteration. 

• Postmarket surveillance plan must be developed for high-risk Class II and Class III medical devices that meet certain criteria set by the FDA.

An Overview of Basic FDA Regulations for Medical Devices

All US-based MD distributors and manufacturers must comply with all FDA regulations, including:

• Establishment Registration – 21 CFR Part 807: Both domestic and foreign manufacturers, as well as initial distributors, ie importers, of medical devices, must register their organizations with the FDA.  
• Medical Device Listing – 21 CFR Part 807: Establishments such as manufacturers, contract manufacturers, contract sterilizers need to provide details of their medical devices.
• Premarket Notification 510(k) – 21 CFR Part 807 Subpart E: A 510(k) is the technical dossier containing detailed technical, safety, and performance information regarding a medical device or an in-vitro diagnostic to be sold in the US; submission of 510(k) is required for most Class II, as well as some Class I and Class III medical devices and in-vitro diagnostics.
• Premarket Approval (PMA) – 21 CFR Part 814: High-risk Class III medical devices found not substantially equivalent to Class I and Class II predicate through the 510(k) process require PMA, which is a scientific and regulatory review to evaluate the safety and effectiveness of the medical devices; compared to the 510(k) process, the PMA process is a more comprehensive and stringent process, which typically requires clinical trials with human participants.  
• Investigational Device Exemption (IDE) for clinical studies – 21CFR Part 812: The IDE allows the collection of safety and effectiveness data via clinical study on investigational devices to support a PMA or a 510(k) submission.
• Quality System (QS) regulation – 21 CFR Part 820: In order to ensure high quality, the QS contains regulatory requirements regarding methods, facilities, and controls constituting the entire medical device lifecycle from designing to servicing.
• Labeling requirements – 21 CFR Part 801: The labeling contains labels on the medical device and descriptive and informative literature accompanying the medical device.
• Medical Device Reporting (MDR) – 21 CFR Part 803: MDR, which contains reporting of adverse events and product problems to the FDA about medical devices by manufacturers, device user facilities, and importers, is one of the post-marketing surveillance tools used by the FDA.

BIOMEDRIC Support for Medical Device Manufacturers

BIOMEDRIC specializes in providing high-end support for all sorts of medical devices regarding preclinical stage, clinical stage, and post-clinical stage. Whether you want to get FDA approval for medical devices or want our consultancy services for medical devices, our specialists would love to know about your requirements for safe practices in the industry.

Not only this, but BIOMEDRIC also gives extensive briefings related to all aspects of medical devices, their types, usage, and the laws. The interface also promotes a user-friendly outlook to assessing the needs and use of the company, with due diligence to the regulations of the FDA.

Please contact us ([email protected] or [email protected]) for the high-quality scientific/technical/regulatory consultancy, reporting, and filing services you may need regarding the FDA regulations for medical devices.