Latest Federal Register Notices
Labeling Recommendations for Surgical Staplers
10/8/2021 Federal Register notice: FDA has announced a final guidance entitled Surgical Staplers and Staples for Internal Use — Labeling Recommendations. The labeling recommendations are intended to address device malfunctions and misuse. To view the notice, click here.
Surgical Staplers Up-classified to Class 2
10/8/2021 Federal Register notice: FDA has issued a final order to reclassify surgical staplers for internal use from Class 1 (general controls) into Class 2 (special controls) and subject to premarket review. The agency is issuing the reclassification on its own initiative based on new information. Between 1/2011 and 3/2018, it received over 41,000 adverse event reports associated with surgical staplers and staples for internal use, including over 360 deaths. Some of the most commonly reported problems, it says, were opening of the staple line or malfunction of the staples, misfiring, difficulty in firing, failure of the stapler to fire the staple, and misapplied staples (applying to the wrong tissue or applying a staple of the wrong size). To view the notice, click here.
Panel to Discuss Moderna, Janssen Vaccine Boosters
10/7/2021 Federal Register notice: FDA has announced a 10/14-15 Vaccines and Related Biological Products Advisory Committee meeting. On 10/14, panel members will discuss an emergency use authorization (EUA) for Moderna’s Covid–19 mRNA vaccine for administering a booster dose in individuals 18 years of age and older. On 10/15, they will discuss a Janssen Biotech EUA for its Covid–19 vaccine’s use as a booster dose in individuals 18 years of age and older. To view the notice, click here.
Revised Guide on Hospital Drug Compounding
10/7/2021 Federal Register notice: FDA has made available a revised draft guidance entitled Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act. The document describes how FDA intends to apply certain provisions of the Federal Food, Drug, and Cosmetic Act to human drug products compounded by state-licensed pharmacies that are not outsourcing facilities and distributed for use within a hospital or health system. To view the notice, click here.
Info Collection Revision on Device Labeling
10/7/2021 Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Medical Device Labeling Regulations” (OMB Control No. 0910-0485). The collection supports medical device labeling requirements governed by section 502 of the Federal Food, Drug, and Cosmetic Act. Device labeling requirements provide for the label or labeling content of a medical device so that it is not misbranded and subject to regulatory action. To view the notice, click here.
Guide on Animal Drug Adaptive Trials
10/6/2021 Federal Register notice: FDA has made available a guidance entitled #268 Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs. The document describes FDA’s current thinking on incorporating complex adaptive and other novel investigation designs into proposed clinical investigation protocols and applications for new animal drugs. To view the notice, click here.