FDA Ground Truth 2026

Nobody on the call could agree on the exact number, and that turned out to be the point. Steve Silverman has heard between 20% and 24% for the share of CDRH's people lost since the start of 2025, Dr. Tarver has used 23%, and the last hard figure anyone had was a little over 2,200 people at the end of 2024. However you slice it, the center that reviews your submissions is in what Silverman calls rebuilding mode, and as he put it plainly, they are not there yet. Philip Desjardins described what that looks like from the filing side: the same three deficiencies come back, but only the first one arrives with the detail it used to, because the scientific reviewers are absorbing work that belonged to people who left. Then Angelina Lisandrelli asked the room how many submissions a single FDA reviewer carries at one time, and the chat guessed five to fifteen. In this MedTech Leading Voice session, six people who deal with the agency every week break down what actually changed on a regulatory professional's desk in the last eighteen months: Steve Silverman (President, The Silverman Group), Philip Desjardins (Partner, Arnold & Porter), Michelle Lott, RAC (Principal and Founder, leanRAQA), Jeff Lipps (Regulatory Affairs and Quality Assurance Consultant), David Filmore (Executive Editor, Market Pathways) and Angelina Lisandrelli (Director of Global Regulatory, Intuitive). They cover the QMSR, the 483s and warning letters issued since 2 February, MDUFA VI and the fees attached to it, what CDRH now says a good pre-submission looks like, and how the agency is using AI and digital records on what you send it. What you'll learn: • How far CDRH's headcount actually fell, and why the center is meeting its MDUFA commitments while authorization times climb • Why the same three deficiencies now come back with real detail on only one of them, and what that means when you write the response • What one reviewer is carrying at a time: the chat's guesses, and the number the panel agreed on • Where the QMSR did not fully harmonize with ISO 13485, why "I meet 13485" is not an answer, and how ISO 14971 fits into the inspection • Why the DHF and DMR are now the medical device file, and what FDA can see that it could not see before • Why risk moved into the top five 483 observations, and what warning letters issued since 2 February now expect from your reply • What MDUFA VI does and does not change, including the new $2,000 fee on most pre-submissions and the facility fee increase • What makes a good pre-submission in CDRH's own words: the question you are asking, the fork in the road, and how clearly you make the ask • How FDA is using AI and digital records in inspections, and what happens when a supplier's quality system was written by a model • What small companies are actually doing about all of it, and why so many would rather take the hit and remediate later Speakers: • Steve Silverman - President, The Silverman Group • Philip Desjardins - Partner, Arnold & Porter • Michelle Lott, RAC - Principal and Founder, leanRAQA • Jeff Lipps - Regulatory Affairs and Quality Assurance Consultant • David Filmore - Executive Editor, Market Pathways • Angelina Lisandrelli - Director of Global Regulatory, Intuitive (Replay + chapters below) 00:00 - Welcome and why this session exists 02:16 - The last 18 months in one pass: QMSR, RAPID, GenAI, and slower authorizations 05:35 - Regulating generative AI under rules written 50 years ago 07:28 - Between 20% and 24%: the resource cut that changed everything 09:59 - Scientific reviewers pick up the slack 11:00 - Same three deficiencies, less detail 13:05 - Poll: how many submissions is one reviewer carrying? 14:22 - Has it felt stable? Morale, Tarver, and the first new reviewer class 17:11 - Can the rebuild restore the capability that was lost? 20:11 - If I meet ISO 13485 I don't have to worry about QMSR: the parts not fully harmonized 21:42 - ISO 14971, risk, and how FDA now inspects for it 23:30 - The DHF and DMR are now the medical device file 30:54 - Risk moves into the top five 483 observations 32:16 - FY2026 inspection history, and what a QMSR-era response has to prove 37:21 - MDUFA VI: boring by design 39:19 - What the agreement buys: TAP and earlier input 41:42 - The new $2,000 fee on most pre-submissions 43:57 - Facility fees and the first real increase in years 49:03 - What makes a good pre-submission, in CDRH's own words 51:44 - Two kinds of pre-sub: a specific question, or a fork in the road 54:40 - Pre-subs carry no fee, and companies are routing around that 59:36 - 483s and warning letters: making your response QMSR-compliant 63:53 - How FDA uses AI and digital records in an inspection 67:33 - Small companies: remediation instead of building it right 72:37 - Accreditation, RAPID, and the CMS-FDA pilot 76:26 - FDA drafting the GenAI rules in the open, and how the room answered the AI poll 81:43 - Close