How FDA Works With Outside Organizations
FDA works cooperatively with many outside organizations, primarily other federal agencies and state, local, tribal, and territorial (SLTT) officials. You may be assigned to work with these organizations through a contractual obligation, statutory requirement, request for expertise, or memorandum of understanding.
When investigating injuries or adverse reactions, you should treat the information as confidential. Follow instructions from your supervisor to handle this type of complaint.
Premarket Approval
The FDA’s rigorous requirements make it challenging to bring a device to market. Having the right expert on your team early in the process is critical to ensure that your product meets all of the regulatory demands and is ready for premarket submission.
For Class III medical devices, the FDA requires a PMA application to demonstrate substantial equivalence to one or more legally marketed devices (predicates). PMA applications include both clinical and non-clinical bench performance data including engineering performance testing, sterility, electromagnetic compatibility, software validation, and biocompatibility evaluations.
For less risky Class II and Class I medical devices, a 510(k) submission is sufficient. The FDA allows companies to submit a 510(k) whenever there is a significant change to a previously cleared device. However, it is much easier for patients to sue medical device makers over problems with devices that received a 510(k) clearance than those that underwent a PMA approval.
Premarket Notification
Most medical devices must be cleared to enter the market by the FDA. Depending on their class, some require a premarket notification (510(k)), or a premarket approval (PMA). A 510(k) submission demonstrates that a device is similar enough to a legally marketed medical device—called the “predicate”—to be deemed substantially equivalent.
The FDA classifies devices based on their risks and potential for harm to patients, as well as how similar the product is to a predicate device that has been cleared by the Agency. The 510(k) program has been the primary mechanism through which the majority of devices obtain U.S. marketing clearance. The FDA’s recently issued draft guidances “Evidentiary Expectations for 510(k) Submissions” and “Recommendations for the Use of Clinical Data in 510(k) Submissions” help improve predictability, consistency, and transparency in this process. The in2being team interprets these new drafts and helps our clients understand how they impact their 510(k) submissions. We also help ensure that submissions comply with the requirements of these drafts and the current version of 510(k) guidance.
Postmarket Surveillance
Postmarket surveillance is an ongoing process that demonstrates the real-world safety of medical devices and pharmaceuticals. This data enables the FDA to better understand the potential risks of a device or drug and take appropriate action to ensure the public’s health and safety.
Manufacturers must report adverse events to the FDA via the MedWatch program. The FDA will then review these reports and, if necessary, will request postmarket surveillance studies to be conducted.
Depending on the nature of your medical device, the FDA may ask you to conduct a single postmarket surveillance study or multiple studies over the life of your product. FDA will review your proposal and approve or deny the plan within 30 days of receiving it.
The FDA will consider your surveillance as delayed when subject enrollment or analysis of the data are behind schedule compared to the projected dates set in your surveillance plan. However, if you are able to get back on schedule during the next phase of your study, the delayed status will no longer apply.
Warning Letters
The FDA may issue a Warning Letter to a firm following an inspection. This is the most serious type of enforcement action that FDA can take and often results in a re-inspection, a directed plan of correction or other regulatory or enforcement actions. In some cases, it can also put a company on the Import Alert list or result in a seizure of imported product or a criminal investigation.
The best way to prevent a Warning Letter is to work closely with FDA during the investigation and development of a CAP that addresses the violations cited in the letter. A well-crafted CAP demonstrates commitment to regulatory compliance and can ultimately result in a close-out letter from the agency.
Companies should also consider the effect of the cited issues on product currently on the market and develop plans to address this. Failure to do so could undermine the credibility of a company’s representation that it is taking steps to correct its processes.
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