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  • Medical Devices

    • A Review of CDRH’s Electronic Submission ProcessSeptember 14th, 2022

      As promised in our posts from earlier this summer (here and here), we are back to report on our assessment of CDRH’s electronic submission process through its Customer Collaboration Portal (CCP).  In short, the process is FANTASTIC!  Say goodbye to your thumb drives and CDs …

    • Choice of Secondary Predicate versus Reference Devices in a 510(k) SubmissionSeptember 13th, 2022

      It’s been almost 11 years since FDA first clarified use of multiple predicate devices and introduced the concept of Reference Devices in the draft guidance titled The 510(k) Program:  Evaluating Substantial Equivalence in Premarket Notifications [510(k)], which we blogged about here.  The final guidance with …

    • Papa Can You Hear Me? Now You Can Thanks to OTC Hearing AidsAugust 18th, 2022

      After 5 long years, FDA has finally adopted the long-awaited OTC hearing aid rules.  While the Proposed Rule was a year and a half overdue, FDA impressively turned out the Final Rule about 7 months after the close of comments on the Proposed Rule, which …

    • FDA Inspections Back Up To Speed (Except Those Now Deemed Unnecessary)August 16th, 2022

      Those of us who work frequently on FDA inspections of drug and medical device manufacturing facilities have noticed an uptick in regular inspections after a dramatic falloff during the first two years of COVID.  That impression was corroborated this week at the GMP by the …

    • ACI’s FDA Boot Camp – September 14-15, 2022 (Virtual)August 5th, 2022

      The American Conference Institute is hosting their 39th FDA Boot Camp from September 14-15, 2022.  The conference will be held virtually. Gain insight and training in core regulatory concepts for life sciences attorneys, business executives, and policy analysts. The approval process, pre-approval concerns, product labeling, clinical trials, …

    • It’s My Party and I’ll Cry if I Want to: A Bittersweet Happy 30th Birthday to LDTsAugust 3rd, 2022

      Happy Birthday Laboratory Developed Tests (LDTs). Thirty years ago today, FDA announced that it had the authority to regulate you.  Not yet understanding how important you’d become, you entered the regulatory world without a name – the Agency simply referred to you as “home brew” products.  …

    • CDRH is NOW Accepting Electronic SubmissionsJuly 31st, 2022

      On July 19, 2022, CDRH announced to users of its Customer Collaborations Portal (CCP) that it is now accepting premarket submissions electronically.  This came quickly after an announcement was made earlier in the summer that this functionality would soon be enabled for existing users of …

    • Electronic 510(k) Submissions Ahead (FINALLY!)July 12th, 2022

      Last month, FDA announced two important steps towards accepting electronic 510(k) submissions.  The first relates to the Customer Collaborations Portal (or CCP).  As discussed in our prior post on the CCP (here), the CCP is currently a submission tracker providing details of completed and upcoming …

    • ‘Til I Hear It From Congress: FDASLA to Direct Publication of Final OTC Hearing Aid RulesJune 22nd, 2022

      There is a lot to unpack in the 430 pages of FDASLA, which means that some provisions are falling a little under the radar.  One of those provisions is an unusual one in which Congress directs FDA to issue final rules concerning Over-the-Counter hearing aids.  …

    • Pre-Submission Program Update from CDRH: A Bit of Welcome NewsJune 8th, 2022

      CDRH appears to be taking another step towards returning to pre-pandemic life.  On May 31, Drs. Shuren and Maisel announced that OHT7 (formerly OIR) will now be accepting all types of pre-submissions (see announcement here).  As you’ll recall from our earlier post (here), OHT7 had …

    • FDA Can’t Always Get What It Wants…So It Asks CongressJune 7th, 2022

      As the User Fee Acts move through Congress, it has been clear that FDA is using them as a vehicle to legislatively overturn some big court losses over the last few years.  As faithful readers of our blog know, FDA’s broad interpretations of its governing …

    • CDRH Returning to Pre-Pandemic Timelines for Premarket Submission HoldsJune 6th, 2022

      On June 3, FDA announced, via email to industry, that it plans to withdraw the guidance “Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices–Questions and Answers (Revised).”  This guidance did two things: (1) automatically extended hold …

    • The FDLI Annual Conference is Back Live!June 1st, 2022

      On June 14-15 in Washington, DC, the Food and Drug Law Institute (FDLI) will hold its first in-person Annual Conference since 2019.  The conference brings together leading regulators and a wide range of stakeholders to discuss current issues and trends of importance to FDA-regulated industries.  …

    • FDA Issues Safety Warning Regarding Non-Invasive Prenatal Testing Raising Questions About the Future of FDA Regulation of LDTsMay 25th, 2022

      On April 19, FDA issued a safety communication regarding genetic non-invasive prenatal screening, commonly referred to as non-invasive prenatal tests or NIPT (here).  NIPT are intended to screen for genetic abnormalities in a fetus.  The tests are not intended to diagnose any genetic conditions – …

    • Highlights from FDA’s Draft MDUFA V Commitment LetterApril 15th, 2022

      On March 22, FDA announced that it reached agreement with representatives from the medical device industry on proposed recommendations to Congress for the fifth reauthorization of the Medical Device User Fee Amendments (MDUFA V).  MDUFA authorizes FDA to collect fees from certain medical device applicants …