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 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.
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.
Share your knowledge and expertise with your regulatory peers by submitting an in-depth, evidence-based article focusing on key areas and emerging issues in the global regulatory landscape.
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.
RAPS Euro Convergence brings regulatory peers from the EU and worldwide together in one forum to gain insights and exchange ideas on the region's most pressing issues. Register today to attend 10-12 May 2021.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
With contributions from more than 30 authors from seven countries, the new edition incorporates a global overview of the field and is designed to help you get the most out of your regulatory intelligence endeavors.
Regipedia is an interactive resource created to benefit RAPS members with 24/7 access to more than 2,300 regulatory terms.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 27 September 2016 | By Zachary Brennan
Concerned with a lack of specifics, Pfizer and US medical device industry group AdvaMed are calling on the US Food and Drug Administration (FDA) to amend its draft guidance on factors to consider regarding the benefits and risks for compliance and enforcement actions.
The draft guidance, released in July and known as “Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions,” is meant to bring FDA’s benefit-risk framework for compliance decisions more in line with how it considers benefit and risk for marketing and investigational device exemption (IDE) application.
In particular, FDA says it considers the following factors when considering a device's benefit in light of compliance and enforcement decisions:
While applauding FDA’s efforts to provide clarity and transparency on how the agency intends to assess and interpret risk and benefit in its decision-making process, AdvaMed makes clear that the lack of specifics raises concerns over how the guidance can be applied.
“With so few specifics, we are concerned that this document cannot be applied consistently within FDA and throughout the industry. Effective guidance must be similarly interpreted by the majority of users in industry and FDA. The draft guidance does not provide an explanation or examples of how FDA will evaluate these benefit and risk factors to make a final decision as to whether or not to take a contemplated enforcement action,” AdvaMed said in comments released late last week.
The group representing device and diagnostic manufacturers also says it is unclear how a manufacturer can anticipate FDA’s risk tolerance.
“Manufacturers have for more than a decade been focusing on risk-based approaches (to compliance, CAPAs [corrective and preventive actions], design improvements, file remediation activities, recalls, etc.), yet FDA can always disagree with the manufacturer’s approach; this document does not provide any thresholds or specifics that would assure manufacturers that FDA would agree with a given decision,” AdvaMed says.
The group also says that it’s concerned that once the draft is finalized, FDA will find it difficult to ensure that center-based staff and field staff understand the decision-making process to mitigate and minimize subjective interpretation of FDA’s expectations for risk assessment during quality management system (QMS) inspections.
Similarly, Pfizer takes particular issue with a method to calculate the number of patients likely to be treated with a nonconforming device.
The draft says: “One method to calculate this likelihood is to take the number of patients treated with a nonconforming medical device and harmed and to divide by the total number of patients treated with nonconforming devices, over a similar time period, if reliable data exist.”
But Pfizer says: “This statement implies a method of acceptable execution. The suggested method is overly simplified and will not apply to most realistic situations. Given years of experience with such situations, it is not advisable to provide a suggested method for this likelihood factor. Each situation will have unique factors that need to be considered. Teams will need to work through the individual situations and determine the best way to assess these likelihood factors. They should then document their decisions and rationale.”
Comments on the Draft Guidance
Tags: Pfizer, AdvaMed, benefit-risk guidance for medical devices, FDA draft guidance
Regulatory Focus newsletters
All the biggest regulatory news and happenings.