Demystifying 12 Myths About the FDA

Several FDA-associated myths are really preconceived notions of what the FDA is thinking. Based on the webinar “FDA Myths and Truths: Common Misconceptions and Surprising Truths,” hosted by ComplianceQuest, let us uncover the truth behind 12 different myths and understand the FDA‘s actual requirements and mindset on manufacturing processes, post-market surveillance, and the applicability of foreign medical device directives.

Myth #1: FDA requires clinical trials and pre-approval for all drugs and devices.

This statement remains a myth, as less risky medical devices need to show only “substantial equivalence.” Clinical data and clinical trials are required for class 3 devices. Technology has certainly changed with regard to medical devices, and this type of technology was not in place when the safe medical devices act was actually passed in May 1976.

Myth #2: The FDA orders most drug and device recalls.

This is false and remains a common misconception that needs clarification. Most of the recalls are instituted by the manufacturer and distributor, not by the FDA. However, the FDA will certainly bring pressure and may threaten a press release or other enforcement action.

Myth #3: The FDA’s mission is to ensure the safety and efficacy of all products it regulates.

This statement is true, as safety and efficacy are equally important to the FDA. The Food and Drug Administration protects public health by ensuring human and veterinary drugs’ security, safety, and efficacy.

Myth #4: The FDA tells companies how to produce their products by detailing good manufacturing practices. The primary goal of governmental regulatory authorities worldwide is to tell a manufacturer how to produce its products.

The FDA is concerned with how the product functions and how the company controls its processes. This statement is false. Globally, government authorities seek to ensure that a manufacturer follows its standard operating procedures. However, in certain situations, FDA suggests performance standards. While The Federal Regulations code will detail information like what must be in your complaint handling procedure, it doesn’t tell you how to write and what processes and steps must be used while manufacturing your product.

Myth #5: Being friendly with the inspector will improve the relationship with the FDA.

This is not true because compliance and striving for inspections with few observations can improve the relationship with the FDA.

Myth #6: FDA has no independent authority to bring suit against the manufacturer or distributor.

This statement is true, as the FDA does not have independent authority. The Department of Justice is the FDA’s lawyer. FDA can ask the Department of Justice to bring suit against a particular company, or the DOJ (The Department of Justice) can come directly to FDA. But there’s no independent authority under the Food, Drug, and Cosmetic for drugs or under the Safe Medical Devices Act for the FDA to sue someone in the room. The Department of Justice will check whether it was fraud or advertising failure. Thus, it helps to prevent contamination using appropriate safety measures.

Myth #7: FDA guidance is binding in the same manner as a final rule or regulation.

This is a myth. The FDA guidance has been there for ten years. FDA guidance is not the law. This is simply the FDA’s thinking at the time, though a company should have a good reason if such guidance is not followed. Unlike regulations that require notice in the comment period, guidance documents do not make amendments to the Code of Federal Regulations, so guidance is not the law.

Myth #8: The FDA can demand that the manufacturer or distributor not promote off-label drug-device usage for the dietary supplement. Promoting products for off-label uses is not prohibited worldwide as long as a particular doctor, or licensed healthcare practitioner supports the use.

This statement is true. FDA makes demands that the product is promoted for the indication. Therefore, US off-label promotion is not allowed. However, individual physicians can prescribe and use products as they see fit without governmental prohibition.

Myth #9: Reporting customer complaints and adverse events are to determine that the regulatory authority is doing its job.

This is a myth. Timely reporting is needed to remove defective products from the marketplace before additional patient harm occurs. Timely reporting operates as designed and is cleared or approved by governmental authorities. This can help you to evaluate whether products are safe and effective for their intended purpose.

Myth #10: The most frequently cited violations are observed during regulatory inspections, particularly regarding medical devices or corrective and preventive actions (CAPA) and complaint handling.

This one is true. Regulators focus on whether a company can find and correct its problems, including design and manufacturing issues, change control, inadequate documentation, etc. The success of corrective actions is dependent on the discovery of the actual root cause. A bandaid approach to fix the problem is not adequate.

Myth #11: Once the European Commission finalized the Medical Device Directives, proposed in September 2012, the FDA accepted these determinations as the basis for approval and clearance of 510 (K) devices.

This statement is false. The EC issued proposed medical device regulations to fill gaps in the regulatory framework and respond to the claim of inadequate product safety controls following an implant scandal in France in 2010. The intent was to broaden the scope of medical device regulations and to strengthen the law on quality assessment, scrutiny, and traceability. FDA does not accept the medical device regulation determination to substitute for its process to revive a PMA, 510 (k), or de novo.

Myth #12: Post-market surveillance is not important as clinical tests, or other data is analyzed when governmental authority first approves a product. This information addresses all the issues, risks, and benefits; nothing new is relevant.

This statement is untrue. Post-market surveillance aims to collect, analyze, and act on the medical device’s post-market real-world performance. All regulators agree that poorly performing devices must be quickly identified, and information about the performance of a device in the real world should be accurately characterized and disseminated.

There is a push for developing national and international registries by product categories rather than manufacturers to protect the health and safety of the public globally. It is necessary to report any adverse events or severe complaints on a timely basis as this is how to further harm to patients can be prevented.

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