The importance of preparing high-quality regulatory documents should never be underestimated. Low quality or poorly written submission documents may lead to expensive delays or rejection of regulatory approvals that can result in launch delays, extra costs, and compliance risks. Typically, submissions come with costs, which can be enormous depending on the type of regulatory filings.
Under the medical device user fee system, standard fees for the fiscal year 2021 covering the period from October 2020 to September 2021 range from $4,936 to $365,657, depending on the application type.
Notably, about 69 percent of 510(k) applications are rejected the first time out of the box. Many of the rejected applications have one or more shortcomings in the RTA checklist. Failing any of the steps will jeopardize or delay the clearance. The high levels of rejection underscore the need to follow best practices to minimize costs associated with going to market.
What is regulatory writing?
Regulatory writing is the production of various regulatory documents that cover the entire lifecycle of a potential submission. The content describes and reports data right from clinical trials through to preparation of regulatory submission documents. It is a constructed narrative that shows a proactive understanding of regulatory requirements, anticipates questions, and preempts compliance issues. It explains why your product should be allowed to be used and showcases the evidence created to support your submission.
Ideally, regulatory writers are given raw information like engineering reports, clinical evidence, test reports, biological compatibility testing, and electrical safety testing. They will take the data and craft high-quality, compelling, and convincing documents that enable authorities to conduct fair and meaningful evaluation of your applications. Typically, an engineer will draft these documents initially, and the regulatory writer will edit it to ensure it has language appropriate for filing.
Notably, regulatory writing is not a one-time event but a continuous process covering all stages of regulatory operations. Once the product receives clearance or approval from the regulating authorities, regulatory writers produce post-approval reports regarding the use and performance of the product, as well as generate documents necessary to support any changes.
What documents form regulatory writing?
Regulatory writers produce such common documents as Investigator Brochures (IBs), Clinical Study Protocols (CSRs), and the Common Technical Document. The target audience of the documents includes the regulatory authorities, notified bodies, and ethics committees. The critical national regulatory authority in the United States is the Food and Drug Administration (FDA).
What is the difference between regulatory writing and medical writing?
Medical writing involves clinical evaluation reports which focus on clinical trial outcomes, literature, and patients to document clinical evidence for device or drug development. Regulatory writing focuses more on non-clinical guidance standards and descriptions to defend the viability of a product. The writer focuses on reporting and describing clinical trial results and all the background, pre-trial, and safety information surrounding them.
What are some best practices in regulatory writing?
Clarity of Story
If the target audience doesn't understand what you write, you might as well have written nothing at all. If you cannot express your ideas clearly, they won't count much either. Regulatory writers should therefore focus on telling a compelling story with clear and fully supported objective evidence. The application of results to acceptance criteria must be clearly written and the message easily understandable from the start to the end. The writings should be consistently supported by objective evidence that underpins the entire document. Other qualities of clearly written documents include a carefully defined purpose, well-constructed sentences, coherent organization, and the right word choice.
Simplicity of Story
One of the secrets to excellent regulatory writing is simplicity. A few simple well-chosen words may be all you need to get even the most complex message across. Crafting your story in a simple, easy-to-understand manner enhances its appeal and makes it easily understandable to a broader audience. Although you sometimes cannot entirely avoid complexities, too much complexity may cause your audience to question your results. Simplicity in writing means knowing your purpose - to help you focus on conveying your message as clearly as possible.
Tell the story in as straightforward a manner as possible. For example, "We tested to look for this, the test was successful, and that demonstrates that the product is safe and effective."
Flawless writings come across as convincing, authentic, and well researched. A critical way of achieving flawless writing is by inculcating the habit of proofreading after writing. Once you are done with your writing, read through it to eliminate common errors, including typos and improper punctuation.
Spelling errors will not stop regulatory submissions from being accepted. However, they may take the reviewer “out of the story” and lead them to question the professionalism of the submitting party.
Develop a standard format or style guide for managing submissions. Your submission templates should feature built-in styles for headers and footers, tables and figure titles and headers. You should also organize information so that it is easy to read and properly sanctioned. When presenting in electronic formats, ensure it supports navigation so that the reviewer can quickly locate what they are looking for. Consider the following elements to improve readability:
Many reviewers won't read your document from start to finish in a single session. Because experts from various disciplines will likely review your document, it means any given reviewer may begin their review at the specific points in the document that is ideal for their discipline. With this in mind, the writer should consider cross-referencing important information needed for a context in multiple places throughout the document. Although too much repetition is not ideal, keep the reviewer in mind when deciding what to repeat and when to repeat it.
Unity of Voice
Your writing must have a unity of voice. This guarantees it sounds like only one person wrote it. Lack of cohesion and unity of voice will take the reviewer "out of the story," and they may start thinking more about why to reject submission than focusing on the submission.
A common misconception is that you need a relevant degree or years of experience to write about a particular regulatory topic. The truth is that you don't need to be a technical expert; you only have to sound like one.
Regulatory writers act as critical communicators for study sponsors and government agencies like the FDA. They have to write highly technical documents for the targeted audience. These documents vary and may include reports, protocols, clinical trials documents, and marketing application approvals, among many others.
Want to learn more about regulatory writing? Subscribe to our blog for the latest updates.