Manfredi Consulting Group

FDA Layoffs & Regulatory Delays – What It Means for Industry Compliance ?? Major FDA Layoffs Could Hinder Regulatory Processes – What Does This Mean for Businesses? Recent mass layoffs at the FDA are raising concerns across the regulatory and compliance industry. As the FDA restructures, companies seeking 510(k) clearances, MoCRA registrations, and product approvals may experience delays, longer response times, and increased scrutiny on submissions. ?? What This Means for Businesses: ? Longer Review Timelines – Expect delays in 510(k) clearances, NDAs, and PMA approvals. ? More Stringent Compliance – With fewer staff, the FDA may rely more on automated screening and stricter documentation requirements. ? MoCRA Uncertainty – The FDA's handling of Modernization of Cosmetics Regulation Act (MoCRA) registrations could face further disruptions. ?? How to Stay Ahead: ?? Ensure regulatory submissions are complete and error-free to avoid unnecessary back-and-forth with the FDA. ?? Stay informed on evolving compliance requirements for medical devices, cosmetics, and supplements. ?? Work with experienced regulatory professionals to navigate these uncertainties efficiently. As industry professionals, we must prepare for these shifting regulatory landscapes. If your company needs guidance on regulatory submissions, compliance strategy, or FDA interactions, feel free to reach out! ?? Read more on the FDA layoffs and their impact: https://lnkd.in/ev7rKHRN #FDA #RegulatoryAffairs #MedicalDevices #MoCRA #510k #Compliance #RegulatoryStrategy #CosmeticsRegulation #ManfrediConsulting

Our CEO, Maria, wrote her thoughts on recent FDA actions and whats ahead for 2025 and beyond. Read it below!

In Case You Missed It ?? This week, the FDA stealthily released a new draft guidance-'Validation of Certain In Vitro Diagnostic Devices (IVDs) for Emerging Pathogens During a Section 564 Declared Emergency' ????Simply put, FDA is giving recommendations to industry for how tests like flu tests should be validated during public health emergencies. Interesting timing- with potentially new zoonotic diseases on the rise, and the current H5N1 bird flu outbreak, as recently highlighted in the news ?? but fear not I’ve read all 30 pages for you, and here’s what stood out to me as an industry expert- ??mRNA, the NEW Gold Standard for IVD validation?! The FDA states mRNA (a synthetic version of RNA) maybe used to validate diagnostic tests. While global standards prioritize using an organic pathogen as the validation specimen, FDA is signaling mRNA could potentially play a bigger role as we face genetically modified pathogens. FDA should clarify if this signals a shift to synthetic mRNA as the new standard, and if so, whats the reasoning? ??FDA is recommending MORE pediatric testing- The FDA is recommending more pediatric-specific testing for validating diagnostics tests. But during COVID-19, tests were approved for all ages without separate studies for kids. A pathogen should register in a test regardless of the subject’s age—this was the principle behind COVID-19 testing. So FDA should clarify why pediatric-specific validation is now being emphasized in IVD's. ??Validation Costs: Who Pays the Price? Stricter validation recommendations could make it harder for smaller companies to compete, potentially leaving the big industry players with leverage over the market. FDA should elaborate plans to balance competition and affordability without stifling innovation. Now your turn, what’s your take on this FDA guidance? ?? Public comments are open until March 10th...ill post link below

?? Exciting News: Our CEO, Maria Manfredi, has been nominated for a federal role that aligns with her dedication to government efficiency, public health, and transparency. ???? With deep experience guiding products safely to market, Maria is committed to optimizing regulatory processes to ensure effective, safe, and accessible healthcare solutions for all Americans. She's now being considered for roles within: ?? Department of Health and Human Services ?? White House Office Maria’s mission is clear: to champion effective, streamlined processes and prioritize transparency in healthcare access and safety standards. Your support is crucial! It takes just 2 minutes to vote and leave a comment on her nomination page. Help us continue to make a healthier, more efficient government possible. Comment 'MAHA' and we will message you the link to vote or vote by visiting the link in comments! Together, let’s continue to Make America Healthy Again! ???? Thank you! #GovernmentEfficiency #PublicHealth #Transparency #MakeAmericaHealthyAgain #Leadership

?? Unlock Faster Medical Device Updates with FDA's New PCCP Guidance! ?? This month the FDA released draft guidance on Predetermined Change Control Plans (PCCPs), and it’s a potential game-changer for medical devices! Check it out here???? https://lnkd.in/ewxW7YDq – it’s time to start talking about how this could transform our industry. Here’s What You Need to Know: ??A Predetermined Change Control Plan (PCCP) is an FDA-approved strategy that allows medical device manufacturers to predefine and streamline future modifications to their devices, ensuring faster implementation while maintaining safety and effectiveness. ??How to leverage the PCCP? The Predetermined Change Control Plan is included as a standalone section in the marketing submission for a medical device, such as in a PMA, 510(k), or De Novo submission. It outlines planned modifications and ensures these changes maintain device safety and effectiveness without needing separate approvals for each update. -Our take on positives for companies: ?? Faster Updates: Implement changes without new submissions every time. ?? Lower Costs: Cut down on regulatory expenses and focus on innovation. ?? Stay Competitive: Bring new improvements to market quickly. -Our take on positives for patients: ? Quick Access to Updates: Get the latest device improvements faster. ??? Safety First: Ensuring all updates keep devices safe and effective. ?? Transparency: Know exactly what changes are made to the devices you rely on. -What Devices Does This Affect? This applies to all medical devices, including 1. General devices, 2. Software as a Medical Device (SaMD), 3. AI/ML-enabled devices, 4. In-vitro diagnostic devices (IVDs), and 5. Combination products. We’re leading the conversation on this exciting change, and we want you to join us! ?????? Get Involved! Head over to the FDA website and share your thoughts on Document GUI00007026* within the next 90 days. Let’s make sure everyone knows about this and let's shape the future of medical devices together! *this is a non-binding draft guidance which is subject to change. #MedTech #PatientCare #Innovation #FDA #Efficiency #Healthcare #LeadingTheConversation

?? Unlock Faster Medical Device Updates with FDA's New PCCP Guidance! ?? This month the FDA released draft guidance on Predetermined Change Control Plans (PCCPs), and it’s a potential game-changer for medical devices! Check it out here???? https://lnkd.in/ewxW7YDq – it’s time to start talking about how this could transform our industry. Here’s What You Need to Know: ??A Predetermined Change Control Plan (PCCP) is an FDA-approved strategy that allows medical device manufacturers to predefine and streamline future modifications to their devices, ensuring faster implementation while maintaining safety and effectiveness. ??How to leverage the PCCP? The Predetermined Change Control Plan is included as a standalone section in the marketing submission for a medical device, such as in a PMA, 510(k), or De Novo submission. It outlines planned modifications and ensures these changes maintain device safety and effectiveness without needing separate approvals for each update. -Our take on positives for companies: ?? Faster Updates: Implement changes without new submissions every time. ?? Lower Costs: Cut down on regulatory expenses and focus on innovation. ?? Stay Competitive: Bring new improvements to market quickly. -Our take on positives for patients: ? Quick Access to Updates: Get the latest device improvements faster. ??? Safety First: Ensuring all updates keep devices safe and effective. ?? Transparency: Know exactly what changes are made to the devices you rely on. -What Devices Does This Affect? This applies to all medical devices, including 1. General devices, 2. Software as a Medical Device (SaMD), 3. AI/ML-enabled devices, 4. In-vitro diagnostic devices (IVDs), and 5. Combination products. We’re leading the conversation on this exciting change, and we want you to join us! ?????? Get Involved! Head over to the FDA website and share your thoughts on Document GUI00007026* within the next 90 days. Let’s make sure everyone knows about this and let's shape the future of medical devices together! *this is a non-binding draft guidance which is subject to change. #MedTech #PatientCare #Innovation #FDA #Efficiency #Healthcare #LeadingTheConversation

No denying #MoCRA is coming! Cosmetic brands & facilities the time is now. Highly unlikely the #FDA will grant another deadline extension. Act now to ensure compliance and avoid any last-minute rush! DM myself or my team to get started. ???? ???? #cosmetics #skincare #compliance #registration #consulting https://lnkd.in/eGn8TPSB

We got you ???????? DM us to get it done?? #fda #mocra #cosmetic #registration #products #facilities

?? Thrilled to see our CEO, Maria Manfredi, shining bright in the spotlight! Big thanks to Jessica Koch for featuring our fearless leader in this recent article. Our team is proud to be part of major advancements in the regulatory & cosmetic space ?? #StayInspired #CEO #Interviews #Regulatory #Cosmetics https://lnkd.in/eUuU8J-Q

?? Must-Watch: Our CEO, Maria Manfredi, shares her journey to leadership and millennial-driven AI insights on Profound Professionals. Get inspired by her story and the innovative tech shaping our future ?? Tune in now!??#LeadershipJourney #AIInnovation #Inspiration