Medical Device Regulatory Tracker
CDSCO (India) & USFDA (US) — Automated Daily Monitor
Last scanned: June 5, 2026 — New entries are added at the top, data is never replaced.
Scan Date: Jun 5, 2026
Medical Device & Diagnostics
| Tab | Latest Entry | Release Date | Size | |
|---|---|---|---|---|
| Public Notices | Risk classification list of medical devices pertaining to Oncology | 2026-Jan-02 | Download PDF | 308 KB |
| Summary: Official notice (File No. MED-16014(12)/1/2024-eoffice, dated 02 Jan 2026) classifying 77 oncology-related medical devices under Rule 4 of Medical Devices Rules, 2017. Devices span radiation therapy systems, ablation systems, hyperthermia systems, cancer diagnostic tools, drug delivery devices, and supportive devices. Risk classes range from A to D. | ||||
| ▶ Archive — 3 older entries (before Dec 2025) | ||||
InVitro Diagnostics (IVD)
| Tab | Latest Entry | Release Date | Size | |
|---|---|---|---|---|
| Public Notices | Addendum to Doc No. CDSCO.IVD.FAQ.04.2022 dated 13.03.2026 | 2026-Mar-13 | Download PDF | 321 KB |
| Summary: Addendum No. 02 (dated 13 March 2026) to the CDSCO IVD FAQ document. Contains 24 FAQs covering: license retention and endorsement procedures, QMS re-inspection requirements, fee structures for Class A/B and C/D IVD imports, late fee provisions under MDR 2017, application limits (max 15 products per application), classification of multi-parameter devices, veterinary IVD requirements, and post-approval change (PAC) procedures. | ||||
| News | Launch of MedTech Mitra’s In-Vitro Diagnostic Innovators Handbook (Short video) | 2025-Dec-23 | Download Video (MP4) | 9854 KB |
| Summary: This entry is an MP4 video (not a PDF). It contains a short video of the launch event for MedTech Mitra’s In-Vitro Diagnostic Innovators Handbook, published on 23 December 2025. | ||||
| ▶ Archive — 2 older entries (before Dec 2025) | ||||
Sources independently verified via Federal Register filings, legal analysis databases, MedTech Dive, and official FDA search indexes. Direct links to FDA source documents are provided for reference.
Scan Date: Jun 5, 2026 — Mar–Jun 2026
Guidance Documents
| # | Guidance Title | Status | Date Issued | |
|---|---|---|---|---|
| 1 | NEW Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements | FINAL | 2026-Jun-05 | |
| Summary: Updated final guidance describing FDA’s intent to exempt certain unclassified (preamendments) medical devices from 510(k) premarket notification requirements. Devices identified are sufficiently well understood that 510(k) review is not needed to assure safety and effectiveness. Until a final rule is published, FDA will not enforce 510(k) compliance for listed device types. Part of CDRH’s broader 2026 initiative to streamline premarket pathways — related Federal Register notices (Feb 6 and May 1, 2026) propose additional Class II device exemptions with comment periods. | ||||
| 2 | NEW Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities — Questions and Answers | DRAFT | 2026-Jun-02 | |
| Summary: Revised draft guidance (replaces June 2018 final guidance) on manufacturer communications of health care economic information (HCEI) about approved/cleared drugs and medical devices to payors, formulary committees, and similar entities. Incorporates updates from Section 3630 of the Consolidated Appropriations Act, 2023. Also addresses communications regarding unapproved products and unapproved uses of approved/cleared products to payors. Comment period open until August 3, 2026 (Docket FDA-2016-D-1307). | ||||
| 3 | Content of Human Factors Information in Medical Device Marketing Submissions | FINAL | 2026-May-28 | |
| Summary: Final guidance establishing a risk-based framework for human factors (HF) information required in 510(k), PMA, De Novo, and HDE submissions. Introduces three HF submission categories based on intended use environment, user interface complexity, existing risk controls, and use-related risk analysis (URRA). Supersedes 2022 draft. Key change: manufacturers must now include expanded HF documentation aligned with new decision factors. Compliance operationalization from August 1, 2026 — submissions received before that date need not include all newly recommended information. | ||||
| 4 | Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle | FINAL | 2026-Mar-27 | |
| Summary: Updated final guidance (supersedes August 2016 version) on how voluntary patient preference information (PPI) may be considered by FDA across the total product life cycle. PPI can inform IDE applications, Breakthrough Device designations, PMA/HDE/De Novo/510(k) reviews, and postmarket enforcement decisions. PPI submission remains voluntary. CDRH Learn module released May 15, 2026. | ||||
| 5 | Medical Devices with Indications Associated with Weight Loss — Premarket Considerations | FINAL | 2026-Mar-12 | |
| Summary: Final guidance establishing a benefit-risk framework for weight-loss medical devices. Key clinical thresholds: “weight loss” indication requires minimum 5% superiority margin; “limited weight loss” requires at least 2%. Responder rate endpoint requires at least 50% of participants achieve at least 5% total body weight loss. Sham-controlled studies recommended for first-in-kind devices. Applies across De Novo, PMA, and 510(k) pathways. | ||||
| 6 | Clinical Decision Support Software | FINAL | 2026-Jan-06 | |
| Summary: Revised final guidance clarifying FDA oversight of clinical decision support software under Section 520(o)(1)(E). Key updates: enforcement discretion for CDS producing a single clinically appropriate recommendation; greater emphasis on transparency of data inputs and logic — especially for AI-driven CDS; expanded examples of Non-Device CDS. Town Hall held March 11, 2026. | ||||
| 7 | Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices | FINAL | 2025-Dec-17 | |
| Summary: Major updated guidance on using real-world evidence (RWE) in device regulatory submissions. FDA removed the previous requirement for identifiable individual patient-level data, enabling large de-identified healthcare datasets. RWE can now support marketing authorization as primary clinical evidence, hypothesis generation, postmarket surveillance, and labeling updates. Industry operationalization from February 16, 2026. | ||||
Scan Date: Jun 5, 2026 — Mar–Jun 2026
CDRH News & Updates
| # | News / Update | Date | Link |
|---|---|---|---|
| 1 | NEW CDRH Celebrates 50th Anniversary of Medical Device Amendments — Director Michelle Tarver Blog Post | 2026-May-28 | Link |
| Summary: CDRH Director Michelle Tarver published a blog post marking the 50th anniversary of the 1976 Medical Device Amendments to the FD&C Act (signed May 28, 1976). The Amendments created the three-tier classification system (Class I/II/III), established the PMA and 510(k) pathways, and formed the foundation of modern medical device regulation. Tarver’s post reflects on five decades of balancing patient safety with innovation and outlines CDRH’s forward-looking priorities. | |||
| 2 | NEW READI-Home Innovation Challenge — Reducing Readmissions through Device Innovation for the Home | 2026-Apr-07 | Link |
| Summary: CDRH launched the READI-Home (Reducing Readmissions through Device Innovation for the Home) Innovation Challenge as part of its “Home as a Health Care Hub” initiative. The challenge promotes development of medical devices enabling monitoring, treatment, and recovery in the home to reduce hospital readmissions. Two phases: Selection (submissions via CDRH portal by Sep 30, 2026) and Interaction (up to 9 participants in FDA “sprint” discussions from Dec 5, 2026). Contact: HealthHomeHub@fda.hhs.gov. | |||
| 3 | CMS & FDA Announce RAPID Coverage Pathway for Breakthrough Medical Devices | 2026-Apr-23 | Link |
| Summary: CMS and FDA jointly announced the RAPID (Regulatory Alignment for Predictable and Immediate Device) coverage pathway. CMS will issue a proposed NCD the same day an eligible device receives FDA market authorization, with a 30-day comment period. This could enable Medicare national coverage within ~2 months vs. the current ~1 year+. Eligible for Class II devices in TAP and any Class III with IDE studies enrolling Medicare beneficiaries. | |||
| 4 | Town Hall — Clinical Decision Support Software, Final Guidance | 2026-Mar-11 | Link |
| Summary: CDRH held a public Town Hall on the updated final CDS guidance. Key topics: clarification of the four statutory criteria defining “Non-Device CDS”; FDA’s enforcement discretion policy for single-recommendation CDS; expanded examples. Presentation slides and transcript available. | |||
| 5 | TEMPO Pilot Program — Follow-Up Requests to Potential Participants | 2026-Mar | Link |
| Summary: FDA began sending follow-up requests to TEMPO (Tailored Approvals to Modernize Patient Access to Digital Health Options) pilot participants. TEMPO streamlines regulatory pathways for digital health technologies. The program is moving from application review to deeper engagement with selected participants. | |||
| 6 | FY2026 CDRH Guidance Agenda Updated — A-List and B-List Priorities | 2026 (Updated) | Link |
| Summary: A-List priorities: 4 final guidances (Real-World Evidence, Predetermined Change Control Plans, Diagnostic Tests for Emerging Pathogens, Patient Preference Information) and 4 draft guidances (AI-Enabled Device Software, Air Purifying Respirators, Menstrual Products, others). B-List: finalization of 3 additional guidance documents. Over 1,350 AI-enabled devices authorized by early 2026. | |||
| 7 | Draft Guidance — AI-Enabled Device Software Functions: Lifecycle Management | 2025-Jan-06 | Link |
| Summary: DRAFT Comprehensive draft guidance covering AI-enabled device software lifecycle — design, labeling, bias mitigation, cybersecurity, postmarket surveillance, and PCCPs. On the FY2026 A-List for finalization. Represents FDA’s shift to operational expectations for AI/ML in medical devices. | |||
| 8 | FDA Industry Information Session — Real-Time Clinical Trials (RTCT) Request for Information | 2026-May-15 | Link |
| Summary: FDA hosted an industry information session to discuss the Real-Time Clinical Trials (RTCT) RFI and proposed pilot program. Two proof-of-concept trials are underway: AstraZeneca TRAVERSE (mantle cell lymphoma) and Amgen STREAM-SCLC (small cell lung carcinoma). Real-time data signals validated through Paradigm Health. Comment period extended to June 29, 2026. Pilot selections expected by August 2026. Impacts medical device trial design and data submission frameworks. | |||
Scan Date: Jun 5, 2026 — Mar–Jun 2026
Letters to Industry
| # | Recipient / Subject | Type | Date | Link |
|---|---|---|---|---|
| 1 | CDRH Data Integrity Notifications — Third-Party Testing Lab Data Rejection | NOTICE | 2026 (ongoing) | Link |
| Summary: CDRH maintains and updates a public page cataloging data integrity concerns from third-party testing facilities. FDA determined that certain testing labs copied study results or submitted falsified/invalid data. All study data from flagged facilities are rejected by FDA until adequately remediated. Manufacturers relying on flagged labs must re-test with compliant facilities. This is a new compliance tool — device sponsors should cross-check their testing partners against this list regularly. | ||||
| 2 | NEW Potential for Nitrosamines in Medical Device Combination Products — CDRH Letter to Manufacturers | NOTICE | 2026-Apr-16 | Link |
| Summary: CDRH issued a letter to manufacturers of CDRH-led combination products regarding potential nitrosamine impurities. The nitrosamine 1-methyl-4-nitrosopiperazine (MeNPZ) has been detected in certain products containing the drug rifampin — including central venous catheters, endoscopic ventricular catheters, hydrocephalus shunt catheters, and absorbable antibacterial envelopes for cardiac implants (ICDs, neurostimulators). Nitrosamine exposure above acceptable levels may increase cancer risk. Manufacturers must evaluate nitrosamine risks from pharmaceutical components and manufacturing processes as part of biocompatibility/risk assessments. No adverse events reported to date. | ||||
| 3 | Medline Industries LP (NAMIC Division) — Angiographic Control Syringes CAPA Failures | WARNING | 2026-Mar-25 | Link |
| Summary: Warning letter (Ref: 723866) issued by CDRH’s Barbara Marsden following a Dec 1–12, 2025 inspection at Medline’s NY facility manufacturing NAMIC Angiographic Control Syringes. Key finding: CAPA ineffectiveness — the firm’s own verification-of-effectiveness data showed complaints-per-million exceeding threshold for 3 consecutive quarters (Q1–Q3 2025) without commensurate action. 250+ complaints and 4 serious injuries linked to syringe adaptor unwinding. Firm eventually initiated removal (806 report filed March 13, 2026). Notable: first warning letter explicitly requiring QMSR-compliant remediation for pre-QMSR inspection findings (QMSR effective Feb 2, 2026). | ||||
| 4 | QMSR Transition — Post-Feb 2, 2026 Enforcement Bridging Expectations | NOTICE | 2026-Feb/Mar | Link |
| Summary: Multiple CDRH warning letters (including IsoTis OrthoBiologics Feb 24, Longhorn Vaccines Feb 26, Medline Mar 25) now contain standardized language: “Any corrective actions proposed or implemented must be pursuant to the QMSR requirements in effect as of February 2, 2026.” This signals that even for inspections conducted under the old QS regulation (21 CFR 820), FDA expects all remediation plans to comply with the new QMSR framework (ISO 13485-aligned). Device manufacturers should update their QMS documentation accordingly. | ||||
Scan Date: Jun 5, 2026 — Mar–Jun 2026
Press Announcements (Medical Device Related)
| # | Announcement | Date | Link |
|---|---|---|---|
| 1 | FDA Safety Communication — Accolade Pacemaker Devices by Boston Scientific | 2026-May | Link |
| Summary: FDA Safety Communication highlighting potential need for early device replacement due to battery failure and Safety Mode entry. Accompanies the Class I recall. Clinicians urged to apply Brady SMR6 software update and report adverse events through MedWatch. | |||
| 2 | FDA Expands AI Capabilities (Elsa 4.0) and Completes HALO Data Platform Consolidation | 2026-May-06 | Link |
| Summary: FDA launched Elsa 4.0 with agentic AI, document generation, data visualization, voice-to-text, and OCR. Consolidated 40+ data systems into HALO (Harmonized AI & Lifecycle Operations for Data). Built within FedRAMP High secure Google Cloud — does not train on industry submissions. Directly impacts device manufacturers’ submission workflows and could accelerate review timelines. | |||
| 3 | FDA Announces Major Steps to Implement Real-Time Clinical Trials (RTCT) | 2026-Apr-28 | Link |
| Summary: FDA announced two proof-of-concept real-time clinical trials (RTCTs): AstraZeneca TRAVERSE (phase 2, mantle cell lymphoma) and Amgen STREAM-SCLC (phase 1b, small cell lung carcinoma). Real-time data signal sharing validated through Paradigm Health. Also released an RFI for a proposed RTCT pilot program launching summer 2026, with pilot selections by August. Comment period extended to June 29, 2026. Signals a shift toward continuous, real-time regulatory data review that could impact device clinical trial design. | |||
| 4 | CMS & FDA Announce RAPID Coverage Pathway to Accelerate Patient Access to Life-Changing Medical Devices | 2026-Apr-23 | Link |
| Summary: Joint press announcement introducing the RAPID pathway. CMS issues a proposed NCD on the same day as FDA market authorization, enabling Medicare national coverage as soon as 2 months post-authorization. Eligible for Class II devices in TAP and any Class III with IDE studies enrolling Medicare beneficiaries. Replaces the prior NTAP “Alternative Pathway.” | |||
Scan Date: Jun 5, 2026 — Mar–Jun 2026
Medical Device Recalls & Early Alerts
| # | Device / Company | Class | Date | Injuries / Deaths | Link |
|---|---|---|---|---|---|
| 1 | Medtronic — DLP Left Heart Vent Catheters | Class I | 2026 (finalized) | 3 injuries / 0 deaths | Link |
| Summary: Catheters resist shape retention when bent, risking perforation. 101,000+ units recalled. Quarantine and return requested. | |||||
| 2 | Conavi Medical — Novasight Hybrid Catheters | Class I | 2026 (finalized) | 0 injuries / 0 deaths | Link |
| Summary: IVUS + OCT catheter sheath detached during use. Risks: coronary spasm, dissection, thrombosis. Catheter safely removed. | |||||
| 3 | Boston Scientific — ACCOLADE Pacemakers & CRT-Ps | Class I | 2026-May-08 | 2,557 injuries / 4 deaths | Link |
| Summary: Software-related battery issue causes premature Safety Mode entry. Brady SMR6 update addresses the risk. Covers over 1 million pacemakers. 4 deaths and 2,557 serious injuries. | |||||
| 4 | NEW Bolton Medical — RelayPro Thoracic Stent Graft System | Class I | 2026-Apr-23 | 0 injuries / 3 deaths | Link |
| Summary: Class I recall of RelayPro Thoracic Stent Graft System (N4: Non-Bare Stent Configuration, 32mm and above) used to repair thoracic aortic aneurysms, dissections, and tears. The proximal clasp may disconnect from the outer control tube, preventing the graft from releasing from the delivery system during implantation. This failure occurs without prior warning and cannot be detected until the procedure is underway. Three patient deaths reported — including one aortic perforation and two conversions to open surgery resulting in fatal strokes. Bolton Medical issued recall letter April 23, 2026, recommending physicians consider alternative stent-graft options until mitigation measures are in place. | |||||
| 5 | Arrow International / Teleflex — Dialysis Catheter Kits (Merit Medical Splittable Sheath) | Class I | 2026-Apr | 2 injuries / 0 deaths | Link |
| Summary: Class I recall of Arrow hemodialysis catheter kits containing Merit Medical 16F Dual-Valved Splittable Sheath Introducers. Design defect: sheath introducer may not split as intended during catheter delivery into the vascular system. Risks include hemorrhage, foreign body retention, embolization/thrombosis, impaired catheter function, and loss of vessel for future vascular access. 2 serious injuries reported. Customers must immediately stop use and return affected kits to Arrow International. | |||||
| 6 | NEW Omnicell — i.v.STATION Automated Compounding System Syringe Labels | Class I | 2026-Apr-10 | 0 injuries / 0 deaths | Link |
| Summary: Class I recall of sterile syringe labels (40mm×40mm PN 258920028 and 20mm×40mm PN 258920029) used with the Omnicell i.v.STATION automated compounding system. Inconsistent label detection behavior across i.v.STATION printers may result in unlabeled or mislabeled syringe preparations after compounding. Risks include wrong drug, wrong dose, or wrong route administration. Customers advised to immediately stop using affected labels and revert to previously ordered non-sterile syringe labels with yellow backing. No injuries or deaths reported. | |||||
| 7 | NEW Cook Medical — Centimeter Sizing Catheters (Incl. Aurous & Beacon Tip) | Class I | 2026-Apr-02 | 3 injuries / 0 deaths | Link |
| Summary: Class I recall of Cook Medical Centimeter Sizing Catheters, Aurous Centimeter Sizing Catheters, and Beacon Tip Centimeter Sizing Catheters — single-use catheters with gold marker bands at increased risk of cracking or breaking. Risks include increased procedural time, device fragmentation/separation, vessel injury, and in worst case, life-threatening harm or death. 3 serious injuries reported. All affected lots must be returned to Cook Medical. Contact: 812-339-0235. | |||||
| 8 | B. Braun Medical — Hemodialysis Bloodlines | Early Alert | 2026-Mar-25 | 0 injuries / 0 deaths | Link |
| Summary: Tubing resin change caused air bubbles to adhere to arterial bloodline. FDA urged alternate dialysis equipment. No injuries reported. | |||||
| 9 | Medline Industries — Namic Angiographic Syringes | Class I | 2026-Mar | 4 injuries / 0 deaths | Link |
| Summary: Syringe rotating adaptor may unwind, causing disconnection. Risks: biohazard exposure, blood loss, air embolism. 250 complaints, 4 serious injuries. FDA also issued warning letter. | |||||
| 10 | J&J MedTech — Impella RP / RP Flex Heart Pumps | Class I | 2026-Mar | 3 deaths (AIC-related) | Link |
| Summary: Malfunctioning dP sensors produce inaccurate readings. Related AIC recall (Dec 2025) linked to 3 deaths. Cybersecurity recalls also issued. | |||||
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