FDA Wants Your Thoughts on Medical Device Paperwork—Again
Published Date: 2/26/2026
Notice
Summary
The FDA is asking for public feedback on their plan to keep collecting info about investigational medical devices—those being tested for safety and effectiveness. This affects companies and researchers working on new medical devices, with no new costs or big changes, just a routine paperwork update. Comments are open until March 30, 2026, so now’s the time to speak up!
Analyzed Economic Effects
3 provisions identified: 1 benefits, 2 costs, 0 mixed.
Overall Paperwork Burden Increased
FDA estimates the total annual paperwork burden for investigational device exemptions increased by 9,919 hours and by 1,033 responses. The agency reports totals of 6,552 annual reporting responses (63,828 hours) and 6,059 recordkeeping records (11,994 hours), reflecting the higher workload for companies and researchers who submit IDE materials.
IDE Application Preparation Time
For investigational device exemption applications and investigational plans (21 CFR 812.20, 812.25, and 812.27), FDA estimates 288 responses annually with an average burden of 80 hours per response, totaling 23,040 hours each year. Other activity-level estimates include items such as 1,500 submissions accepting foreign clinical data averaging 10.25 hours each (15,375 hours).
Use of Leftover Specimens Without Consent
FDA’s guidance (GFI IVD Leftover Specimens April 2006) states the agency does not intend to object to use of leftover human specimens without informed consent if the specimens are not individually identifiable and the study meets the exemption criteria in 21 CFR 812.2(c)(3). This allows investigators to use remnants of specimens collected for routine clinical care in certain IDE studies while protecting subject privacy.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-16296, Substances Generally Recognized as Safe
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2026-16959, Frequently Asked Questions-Developing Potential Cellular and Gene Therapy Products; Final Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Frequently asked Questions--Developing Potential Cellular and Gene Therapy Products." The guidance document provides industry with answers to frequently asked questions (FAQs) and commonly faced issues that arise during the development of cellular and gene therapy (CGT) products. The FAQs represent common questions directed to the Agency and span multiple disciplines, including regulatory review; chemistry, manufacturing, and controls (CMC); pharmacology/toxicology; clinical; and clinical pharmacology. This guidance announced in this notice finalizes the draft guidance of the same title issued on November 19, 2024.
2026-16944, Gardenia Blue Interest Group; Filing of Color Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Gardenia Blue Interest Group (GBIG or petitioner), c/o Exponent, Inc., proposing that we amend our color additive regulations to expand the safe use of gardenia (genipin) blue in various foods at levels consistent with good manufacturing practice. The petition also proposes to lower the specification for arsenic in gardenia (genipin) blue.
2026-16942, Food Additives Permitted in Feed and Drinking Water of Animals; Chromium DL-methionine Chelate
The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of chromium DL- methionine chelate as a nutritional source of chromium in cattle feed. This action is in response to a food additive petition filed by Zinpro Corp.
Previous / Next Documents
Previous: 2026-03855, Determination of Regulatory Review Period for Purposes of Patent Extension; LIMFLOW SYSTEM
The FDA has officially set the review period for the LIMFLOW SYSTEM, a medical device, so its patent can be extended. This affects the company behind LIMFLOW and anyone interested in patent timing or challenges. If you think the dates are wrong or the company wasn’t careful during review, you can speak up by April 27 or August 25, 2026.
Next: 2026-03858, Combined Notice of Filings #1
The Federal Energy Regulatory Commission got several new filings from energy companies about accounting changes, new energy storage projects, and updates to electric rates. These changes could affect how some companies handle their money and operations, with public comments open until early to mid-March 2026. If you’re involved in energy or just curious, now’s the time to check in and have your say!