Description
The Food and Drug Administration (FDA) is committed to helping patients gain more timely access to new medical devices and to maintaining continued access to existing medical devices that are high quality, safe and effective, by expediting their development, assessment, review, and surveillance, consistent with the Agency's statutory mission to protect and promote the public health. By streamlining regulatory processes and removing or reducing unnecessary burdens associated with FDA regulatory activities, patients can have earlier and continued access to beneficial products.
Scope & Applicability
Product Classes
10FDA intends to assess device cybersecurity based on a number of factors; demonstrate or maintain its safety and effectiveness; ensuring cybersecurity has become essential to FDA’s ability to protect the public health; Cyber-resiliency capabilities for medical devices
Low risk devices under enforcement discretion
Subject to enforcement discretion policy
Analytical studies for long-term outcomes
Software performing medical purposes without being part of hardware
Device category that may be exempt from certain UDI requirements if GMP exempt.
Device classification mentioned regarding novel sterilization methods
support determinations of a reasonable assurance of safety and effectiveness
Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
Generally recommended for Enhanced Documentation; Regulatory classification mentioned for implantable sensors and HPV tests; Mentioned in the context of an in vitro nucleic acid test for CMV DNA.
Stakeholders
3Consulted to establish OPC for endometrial ablation devices
Firms requesting feedback on inspectional observations
Entity responsible for submitting NDINs
Related CFR Sections (3)
- 21CFR803.19§ 803.19 Are there exemptions, variances, or alternative forms of adverse event reporting requirements?
(a) We exempt the following persons from the adverse event reporting requirements in this part:Read full regulation →
- 21CFR814.39§ 814.39 PMA supplements.
(a) After FDA's approval of a PMA, an applicant shall submit a PMA supplement for review and approval by FDA before making a change affecting the safety or effectiveness of the device for which the applicant has an approved PMA, unless the change is of a type for which FDA, under paragraph (e) of thRead full regulation →
- 21CFR860.7§ 860.7 Determination of safety and effectiveness.
(a) The classification panels, in reviewing evidence concerning the safety and effectiveness of a device and in preparing advice to the Commissioner, and the Commissioner, in making determinations concerning the safety and effectiveness of a device, will apply the rules in this section.Read full regulation →
Related Warning Letters (10)
- 2025-12-09
CGMP/QSR/Medical Devices/Adulterated
Envoy Medical Inc.
- 2025-11-25
CGMP/QSR/Medical Devices/Adulterated
Hong Qiangxing Shenzhen Electronics Limited
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated
Contec Medical Systems Co., Ltd.
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Royal Philips
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Qianjiang Kingphar Medical Material Co Ltd.
- 2025-10-21
CGMP/QSR/Medical Devices/Adulterated
LEVO AG
- 2025-10-07
CGMP/QSR/Medical Devices/Adulterated
Technological Medical Advancements LLC
- 2025-09-23
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
The Richline Group, Inc.
- 2025-09-16
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
SeniorLife Technologies, Inc.
- 2025-08-26
CGMP/QSR/Medical Devices/Adulterated
Miach Orthopaedics
See Also (8)
- Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS) - Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases: Guidance for Stakeholders and Food and Drug Administration Staff (Status: Final)
- CPG Sec. 398.450 Applicability of Positive Beam Limitation (PBL) Requirements When PBL is Provided on "Other than Stationary General Purpose" Radiographic System (Status: Final)
- CPG Sec. 300.600 Commercial Distribution with Regard to Premarket Notification (Section 510(k)) (Status: Final)
- CPG Sec. 345.200 Diaphragms - Rx Devices (Status: Final)
- CPG Sec. 350.100 Packaging Technologies and Tamper-Resistant Packaging Requirements for Contact Lens Solutions and Tablets (Status: Final)
- Device Labeling Guidance #G91-1 (Blue Book Memo) (Status: Final)
- Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology (Status: Final)
- Guidance for the Content of Premarket Notifications for Ureteral Stents (Status: Final)