FDA Compliance Tips: Ensuring Data Reliability for Medical Device Submissions
FDA Medical Device Team Lead
FDA Medical Device Team Lead
Former DOJ Attorney
FDA Medical Device Team Lead
Former Senior DOJ Trial Attorney
For medical device manufacturers navigating the pre-market approval (PMA) and pre-market notification (PMN) processes, ensuring data reliability is crucial for establishing U.S. Food and Drug Administration (FDA) compliance. The FDA requires all submissions for medical devices to be based on verifiable data, and device manufacturers seeking authorization to bring their devices to market must be prepared to provide these data for the FDA’s review. Any concerns about the reliability of a device manufacturer’s data can delay the PMA or PMN process, and any suggestion that a manufacturer’s data may be fabricated or intentionally misleading can lead to additional consequences.
The FDA has recently raised specific concerns regarding medical device manufacturers’ use of third-party data to support their pre-market submissions. As the FDA explains:
“In recent years, the FDA has observed that an increasing number of entities that contract with device firms to conduct testing on medical devices (‘third-party test labs’) are generating testing data that are fabricated, duplicated from other device submissions, or otherwise unreliable. When such data are submitted to the FDA, the agency is unable to rely on them to grant marketing authorization and it calls into question the data integrity of the entire file.
The FDA has identified an increase in submissions containing unreliable data generated by third-party test labs, including from numerous such facilities based in China and India. . . .”
Regardless of whether a medical device manufacturer conducts its testing in-house or relies on a third-party test lab, the manufacturer is ultimately responsible for the data it submits to the FDA. Not only can unreliable data lead to denial of a manufacturer’s PMA or PMN submission; but, in some cases, it can lead to fines and other penalties as well.
5 Tips for Ensuring Submission of Reliable Data to the FDA
With this in mind, medical device manufacturers cannot afford to take chances when it comes to ensuring data reliability and eliminating data integrity violations. Here are five tips manufacturers can follow to avoid unnecessary issues during (and after) the pre-market submission process:
Tip #1: Ensure that Third-Party Test Labs Have Adequate Qualifications
According to the FDA, “it is incumbent on device firms to take proactive steps to qualify third-party test labs” that they use for pre-market submission purposes. This underscores the FDA’s position that reliance on a third-party test lab is not an excuse for non-compliance. When choosing labs to conduct third-party testing, medical manufacturers must do their due diligence, and they must make an informed decision about the lab they choose to use based on the lab’s own FDA compliance program, its prior work, and other relevant factors.
Additionally, as the FDA notes, while it “encourages” medical device manufacturers, “to partner with third-party labs that have been voluntarily accredited under the Accreditation Scheme for Conformity Assessment (ASCA) program, doing such does not substitute for conducting an independent assessment of all third-party data.” Thus, while ASCA accreditation is a relevant factor for medical device manufacturers to consider, choosing an ASCA-accredited lab is not sufficient on its own.
Tip #2: Scrutinize Testing Data for Potential Red Flags
The FDA also expects medical device manufacturers (or “firms”) to, “closely scrutinize all testing data that a firm does not perform itself, especially relating to biocompatibility and other performance testing.” In other words, manufacturers cannot simply obtain data from a third-party test lab and then submit these data to the FDA. While the FDA acknowledges that, “it may be difficult for individual device firms to know if certain data have been copied from an unrelated marketing submission,” it also “expect[s] device firms to identify testing results that are improbable or impossible on their face or do not seem consistent with known information about the device.”
In particular, the FDA has noted multiple instances of third-party test labs duplicating data from prior tests and fabricating data that are not based on any testing at all. In most cases, manufacturers should have some idea of what they expect from their devices’ testing, and they should be able to flag data that are grossly misaligned with their expectations. As discussed below, when manufacturers have any doubts or concerns about their data’s reliability, they should err on the side of caution and engage with their third-party testing lab or seek verification from another testing provider.
Tip #3: When In Doubt, Err on the Side of Caution
When it comes to submitting data to the FDA, medical device manufacturers should always err on the side of caution. Not only can submitting unreliable data lead to denial of a pre-market submission, but it can also increase a manufacturer’s risk of facing FDA scrutiny in the future as well. Devoting the time and resources necessary to ensure that a PMA or PMN submission contains reliable data is well worth it—particularly (but not exclusively) when a manufacturer has doubts or concerns about data generated by a third-party test lab.
Tip #4: Focus on Substantiation, Not Confirmation
The purpose of the FDA’s data requirement for pre-market submissions is to substantiate manufacturers’ claims of safety and effectiveness or substantial equivalence to a predicate device. With this in mind, when conducting testing (or working with a third-party test lab), medical device manufacturers need to focus on substantiation, not confirmation. In other words, the purpose of testing should not be to obtain data that support a specific claim the manufacturer wishes to make, but instead to obtain unbiased and reliable data that provide an accurate picture of safety, effectiveness, or substantial equivalence. If the data obtained from testing are unfavorable, then a manufacturer must focus on addressing any issues with its device rather than focusing on making the data say what the manufacturer wants the data to say.
Tip #5: Implement Policies and Procedures Designed to Ensure Collection and Submission of Reliable Data
For medical device manufacturers, the key to avoiding data-related PMA and PMN denials is to implement policies and procedures that are designed to ensure data reliability. All medical device manufacturers should have custom-tailored FDA compliance programs that include specific protocols for testing, data analysis, and data submission. By taking a systematic approach to engaging third-party test labs, reviewing testing data, and preparing data for submission to the FDA, manufacturers can ensure that oversights and other mistakes do not lead to problems that could—and should—have been avoided.
At Oberheiden P.C., our lawyers and consultants rely on extensive experience to help medical device manufacturers prepare compliant pre-market submissions and ensure that their data will not raise red flags during the FDA’s review. This includes prior experience as FDA compliance officers and investigators. We can work with your team to implement all necessary policies and procedures, and we can provide advice and representation throughout the PMA or PMN submission process.
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FAQs: Ensuring Data Reliability for Medical Device FDA Pre-Market Submissions
How Does the FDA Assess the Reliability of Data Included with Pre-Market Submissions?
The FDA assesses the reliability of data included with pre-market submissions through a variety of means. Broadly, when examining medical device manufacturers’ data, the FDA looks for red flags indicating fabrication, duplication, modification, and other deceptive practices. When in doubt, the FDA will ask for substantiation; and, if dissatisfied with a manufacturer’s substantiation, the FDA will deny authorization or approval.
What is the FDA’s Real-World Data (RWD) and Real-World Evidence (RWE) Framework?
The FDA adopted a Framework focused on using real-world data (RWD) and real-world evidence (RWE) to evaluate pre-market submissions in 2018, and this Framework remains a key FDA compliance tool today. While the Framework applies primarily to pharmaceutical submissions, many of the fundamental principles are relevant to medical device manufacturers preparing PMA and PMN submissions as well.
Is It Okay for Medical Device Manufacturers to Use Third-Party Test Labs?
Yes, the FDA expressly acknowledges that medical device manufacturers frequently use third-party test labs to generate the data they need for PMA and PMN submissions. However, it also makes clear that manufacturers have a duty to ensure that the labs they choose generate reliable data, including those used for clinical trials, and that reliance on a third-party test lab is not an excuse for submitting false or misleading data to the FDA.
How Should I Choose a Third-Party Test Lab?
When choosing third-party test labs, medical device manufacturers should evaluate labs’ FDA compliance programs and confirm their ASCA accreditations. Manufacturers should also seek information about the lab’s prior tests for similar devices and tour the lab’s facilities, if possible. Negotiating appropriate representations, warranties, and other protections into the manufacturer’s contract with the lab is critical as well.
How Can Medical Device Manufacturers Effectively Manage FDA Data Reliability Compliance?
Effectively managing FDA data reliability compliance requires a proactive approach based on the advice of experienced legal counsel. At Oberheiden P.C., we have extensive experience assisting medical device manufacturers with all aspects of FDA compliance, including all compliance matters related to data integrity.
Contact the FDA Compliance Team at Oberheiden P.C. for More Information
If you would like to know more about our FDA compliance services for medical device manufacturers, we invite you to get in touch. Please call 888-680-1745 or contact us online to schedule a complimentary initial consultation today.
