FDA MDSAP Audits

Experienced FDA Compliance Counsel for MDSAP Audits

For U.S. medical device manufacturers that sell their products around the globe, meeting the U.S. Food and Drug Administration’s (FDA) requirements is just one component of a much larger compliance process. Medical devices are subject to premarket review and approval in numerous countries through international medical device regulators, and manufacturers must be able to clearly demonstrate compliance with each country’s requirements before they will be allowed to bring their products to market. One way that manufacturers can demonstrate compliance is through the Medical Device Single Audit Program (MDSAP Program).

Undergoing an MDSAP audit allows medical device manufacturers to establish their devices’ eligibility for sale in all countries that recognize MDSAP audits as a means of demonstrating compliance. As the FDA explains, “[t]he Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.” Thus, while undergoing an MDSAP audit is a time and resource-intensive process, it can also be a highly efficient means of securing authorization to market new medical devices in multiple jurisdictions.

Currently, the jurisdictions that recognize MDSAP audits include:

• Australia
• Brazil
• Canada
• Japan
• United States

At Oberheiden P.C., we guide medical device manufacturers through the MDSAP audit process. Our lawyers and consultants can ensure that your company is fully prepared for its MDSAP audit, work with the recognized Auditing Organization on your company’s behalf, and shepherd your company’s device through the process while addressing any issues that arise along the way. With our proactive approach to MDSAP audit preparation, we are able to help our clients avoid these types of issues in most cases; and, when issues arise unexpectedly, we are prepared to resolve them quickly so that they do not lead to undue costs and delays.

Put our highly experienced team on your side

Dr. Nick Oberheiden

Founder

Attorney-at-Law

Lynette S. Byrd

Former DOJ Trial Attorney

Partner

Brian J. Kuester

Former U.S. Attorney

Hon. Kevin McCarthy

55th Speaker, U.S. House of Representatives (ret.)

Government Consultant

Mike Pompeo

Of Counsel

Former U.S. Secretary of State

John W. Sellers

Former Senior DOJ Trial Attorney

Linda Julin McNamara

Federal Appeals Attorney

Nicholas B. Johnson

Former Prosecutor

Roger Bach

Former Special Agent (DOJ)

Chris J. Quick

Former Special Agent (FBI & IRS-CI)

Michael S. Koslow

Former Supervisory Special Agent (DOD-OIG)

Ray Yuen

Former Supervisory Special Agent (FBI)

5 Key Facts About MDSAP Audits for Medical Device Companies

While undergoing an MDSAP audit can be an efficient means of establishing compliance with the requirements for medical device approval in the U.S. and other participating countries, engaging a recognized Auditing Organization isn’t the best choice for all medical device manufacturers in all scenarios. Here are five key facts for manufacturers to consider:

1. While MDSAP Compliance Doesn’t Entail Additional Requirements, the FDA’s Requirements are (Currently) Different from Those in Other Countries

As the FDA makes clear, “[t]he MDSAP audit model was developed to cover existing requirements from the Regulatory Authorities participating in the MDSAP. The program does not add any new requirements to existing requirements from ISO 13485 or other country-specific requirements of the participating Regulatory Authorities..” Even so, this doesn’t necessarily mean that undergoing an MDSAP audit will be the most efficient approach in all cases. For example, the United States currently has different approval requirements than most other countries (though this will change when the FDA’s new Quality Management System Regulation (QMSR) takes effect in early 2026). So, if a manufacturer is only planning to sell its devices in participating countries other than the U.S., undergoing an MDSAP audit may not be worth it.

2. Preparing for (and Undergoing) an MDSAP Audit is a Time and Resource-Intensive Process

As we mentioned above, preparing for (and undergoing) an MDSAP audit is a time and resource-intensive process. While this is true of any premarket submission review, MDSAP audits tend to be even more intensive by their nature. Not only must medical device manufacturers be prepared to demonstrate compliance with each relevant jurisdiction’s device approval requirements, but they must be prepared to deal with the recognized Auditing Organization’s practices and procedures as well.

3. Recognized Auditing Organizations Are Private Companies, and Manufacturers Can (and Should) Select Their Auditors Carefully

Recognized Auditing Organizations are private companies that have been selected by the FDA and other participating regulatory authorities. A list is available on the FDA’s website. Since Auditing Organizations need to maintain their recognition by participating authorities, they have a strong interest in vigorously enforcing the MDSAP’s requirements. As a result, when going through the MDSAP audit process, manufacturers can expect to face intensive scrutiny and various challenges—making it essential to work with experienced compliance counsel.

4. Manufacturers (and Their Counsel) Must Be Prepared to Play an Active Role in the MDSAP Audit Process

To ensure that their MDSAP audits go as smoothly as possible, medical device manufacturers (and their counsel) must be prepared to play an active role in the audit process. In this regard, MDSAP audits are similar to Medicare and Medicaid audits conducted by CMS’s fee-for-service audit contractors. Manufacturers should not assume that the audit process will result in a favorable outcome, no matter how much they do to prepare, and they must be able to rely on their counsel to intervene when auditors’ mistakes, oversights, and flawed assumptions stand in the way of securing multi-jurisdictional approval.

5. Successfully Completing an MDSAP Audit is Just One Step in the Device Approval Process in the U.S. and Abroad

While successfully completing an MDSAP audit allows medical device manufacturers to efficiently secure multi-jurisdictional approval, doing so is just one step in the approval process. After undergoing MDSAP audits, manufacturers must then work with their counsel to successfully navigate each relevant jurisdiction’s premarket submission process. In the U.S., this process varies depending on whether a device falls into the FDA’s Class I, Class II, or Class III, and the approval process for different classes of devices can vary in other countries as well.

How Our Lawyers and Consultants Help with MDSAP Audits

At Oberheiden P.C., our lawyers and consultants provide end-to-end advice and representation for MDSAP audits. We make sure our clients are fully prepared before initiating the audit process, and then we oversee the entire process to help ensure that unwarranted issues do not lead to unnecessary costs and delays. We assist our clients with all other aspects of FDA compliance as well—from navigating the premarket submission process for Class I, Class II, and Class III devices to managing an effective FDA compliance program on an ongoing basis. When assisting medical device manufacturers with MDSAP audits, our services include:

• Assessing compliance with the medical device approval requirements in each relevant MDSAP-participating country, and assisting with additional compliance measures as necessary;
• Documenting compliance so that our clients are prepared to proactively demonstrate satisfaction of all pertinent requirements; 
• Selecting a recognized Auditing Organization and initiating the MDSAP audit process; 
• Overseeing the entire MDSAP audit process, and intervening as necessary to prevent auditors’ mistakes, oversights, and misinterpretations from leading to unnecessary problems; and, 
• Assisting with the finalization of our clients’ MDSAP audits, submitting their audit records (and all additional necessary documentation) to the relevant regulatory authorities, and guiding our clients through the premarket approval process in all desired MDSAP-participating jurisdictions. 

FAQs: Successfully Navigating the MDSAP Audit Process

Discuss Your Company’s MDSAP Audit with a Member of Our FDA Compliance Team

Do you have questions about the MDSAP audit process? If so, we encourage you to contact us for a complimentary initial consultation. To speak with a member of our FDA compliance team at your convenience, give us a call at 888-680-1745 or tell us how we can get in touch online today.