Tag Archives: Medical Device

FDA Releases FY 2027 MDUFA Fees

FDA Releases FY 2027 MDUFA Fees New 510(k), De Novo, PMA & Establishment Registration Costs Are Here! Is Your Regulatory Budget Ready? Effective Date: October 1, 2026 – September 30, 2027 The U.S. Food and Drug Administration (FDA) has published the Medical Device User Fee (MDUFA) rates for Fiscal Year (FY) 2027. The new fees

Is Your Product Still an FDA-Regulated Device in 2026?

The Answer Might Surprise You. One of the most common questions we have received from manufacturers, software developers, and startup founders this year is: Is my product still considered a medical device by the FDA?" The short answer is: maybe not—but don't assume. In 2026, the FDA continued refining its approach to certain low-risk health

FDA Establishment Registration for Medical Devices — What Foreign Manufacturers Get Wrong

  For foreign medical device firms, FDA establishment registration and U.S. Agent designation are not optional—they are mandatory requirements for accessing the U.S. market. Errors in either process can lead to shipment delays, import holds, or FDA Import Alerts that disrupt business operations and market access. Drawing on nearly 50 years of regulatory experience and

What FDA Inspectors Are Actually Checking Under the New QMSR

FDA UPDATE What FDA Inspectors Are Actually Checking Under the New QMSR — mdi’s First-Hand Findings The FDA’s QMSR replaced the old QSR on February 2, 2026 — and if your quality system documents still reference 21 CFR Part 820 sections instead of ISO 13485 clauses, your next FDA inspection will expose that gap immediately.

Medical Device User Fee Amendments

FDA UPDATE Medical Device User Fee Amendments (MDUFA) FY2026 – !Exciting News for Small Businesses! The FDA has officially released the Medical Device User Fees for FY2026, and there’s great news for small business firms! For the first time ever, the FDA is offering a waiver for the Annual Establishment Registration Fee—a huge win for

Import Alerts for Certain Olympus Medical Devices

FDA Update – June 25, 2025 Import Alerts for Certain Olympus Medical Devices Manufactured in Japan – Letter to Health Care Providers We are seeing more and more regulatory actions against foreign companies because of lack of FDA QSR compliance. When a company has a violative inspection, and the FDA does not accept their corrective

The FDA Sends Two Warning Letters after Inspecting Chinese Syringe Manufacturers

FDA Update The Safety of Syringes Imported into the US Called into Question As: The FDA Sends Two Warning Letters after Inspecting Chinese Syringe Manufacturers The FDA named companies Jiangsu Shenli and Jiangsu Caina as targets of its investigation into the safety of plastic syringes made in China in March. The agency had not completed

At-Home Use Medical Technologies

FDA Update The FDA is Seeking Public Comments CDRH Seeks Public Comment: Increasing Patient Access to At-Home Use Medical Technologies The U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) seeks input from the public, particularly patients, patient advocacy organizations, health care providers, consumers, the medical device industry, clinical researchers, and

FDA UPDATE: An UPDATED EUA Discontinuance List

We want to keep everyone updated on the FDA EUA situation and for which devices they have discontinued the EUAs. We knew that the EUA was only temporary under the emergency COVID situation and now the FDA is starting to cut back on the EUAs as they have more supplies available to the marketplace via

FDA Update: Hearing Aid – OTC

Hearing Aid – OTC For those with mild to moderate hearing loss the day may be close when hearing aids are available over the counter… The FDA Issues Proposed Rule for Establishing Over-the-Counter Hearing Aids and Draft Guidance for Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products Hearing loss affects an estimated