Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Resources, news and special offers to support you and your professional development during this difficult time.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Download your copy of the new events calendar and see all the online workshops, conferences, RAC exams and European online workshops RAPS has planned for 2021 at a glance.
Registration is now open for RAPS Euro Convergence 2021! Attend to join peers from EU and around the world to gain insights and exchange ideas on the regions most pressing issues.
An invaluable resource for any professional engaged in designing, composing, compiling, or commenting on regulatory documentation
From self-assessments to help you identify your strengths and areas to focus on to reference books and online courses that will help you fill in the gaps in your regulatory knowledge, RAPS has the resources to help you prepare for the RAC exam.
The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move across top level links and expand / close menus in sub levels. Up and Down arrows will open main level menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab will move on to the next part of the site rather than go through menu items.
Posted 30 January 2018 | By Michael Mezher
Companies participating in the US Food and Drug Administration's (FDA) pilot software pre-certification program reflected on their experiences in the earliest stages of the pilot at a public workshop in Bethesda, MD on Tuesday.
Last year, FDA launched its "Pre-Cert" pilot program for software-based medical devices as part of its Digital Health Innovation Action Plan.
In September, the agency selected nine companies to participate in the pilot: Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool and Verily.
Since then, FDA has gone on a series of two-day site visits to each of the participants to identify traits and practices at each of the companies that could contribute to organizational excellence and software quality and how those approaches could integrated into a model for pre-certifying a company's products.
Ahead of the workshop, FDA also updated its questions and answers page on the Pre-Cert pilot and released an overview of its first steps and proposed excellence model for validating company's software development practices.
Kicking off the two-day workshop, Center for Devices and Radiological Health (CDRH) Director Jeffery Shuren said the goal of the pilot is to figure out how to build a regulatory pathway for digital health products that will encourage companies to come forward with innovative new products.
"We want this program to be scalable, we want this program to be easy, we want this program to align as closely as possible to how businesses run and make products," said Bakul Patel, associate center director for digital health at CDRH.
By and large the participants in the pilot applauded FDA's efforts and approach, and agreed that the agency's existing review pathways are not well-suited to software-based products.
"The decades old regulatory paradigm just did not contemplate the challenges that we see with the rapid innovation and iterative nature of software, so the precertification pilot for us was the first step in trying to find a more fit-for-purpose regulatory paradigm," said Danelle Miller, vice president of global regulatory policy at Roche.
Jennifer Newberger, senior legal counsel at Apple echoed that thought, saying "there really is a genuine interest here in creating something that is specific to the situation. It isn't taking what already exists and tweaking it slightly to make it work for software, it's really trying to create something new for software and the pace at which software develops."
Both Miller and Newberger also said that it's hard to separate out some of the existing regulatory requirements for medical devices, such as establishing a quality system or maintaining a design history file, but said that an approach focused on organizational excellence could yield quality digital health products.
After taking part in her company's site visit, Diane Johnson, digital health policy lead at Johnson & Johnson, said the one lingering question she had was how FDA will approach enforcement for pre-certified companies.
But Patel replied that FDA still does not have a precise idea about the level of enforcement that will be required to oversee pre-certified products or the specific metrics they will be looking at.
FDA
Regulatory Focus newsletters
All the biggest regulatory news and happenings.