Scope & Applicability
Product Classes
5FDA 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
Device classification mentioned regarding novel sterilization methods
Medical devices intended for human use; Approved or cleared medical devices
Low risk medical devices
Devices requiring training and monitoring throughout TPLC
Stakeholders
2Entity responsible for submitting applications under section 524B
Entity responsible for submitting NDINs
Regulatory Context
Attributes
7relevance includes the availability of data for key study variables
adequate statistical power and accounting for planned analyses
Ability to track the history of data
Importance of data extraction and curation history
statistically justified calculation required in the plan
reliability includes accuracy, completeness, and traceability
Classification of metallic and calcium phosphate coated orthopedic devices
Related CFR Sections (4)
- 21CFR801.40§ 801.40 Form of a unique device identifier.
(a) Every unique device identifier (UDI) must meet the technical requirements of § 830.20 of this chapter . The UDI must be presented in two forms:Read full regulation →
- 21CFR830.3§ 830.3 Definitions.
As used in this part:Read full regulation →
- 21CFR812.28§ 812.28 Acceptance of data from clinical investigations conducted outside the United States.
(a) Acceptance of data from clinical investigations conducted outside the United States to support an IDE or a device marketing application or submission (an application under section 515 or 520(m) of the Federal Food, Drug, and Cosmetic Act, a premarket notification submission under section 510(k) Read 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)
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Royal Philips
- 2025-09-30
Medical Device Reporting/Misbranded
Insung Medical Co. Ltd.
- 2025-09-09
Clinical Investigator
Shirish M. Gadgeel, M.D.
- 2025-07-15
Clinical Investigator
Mark J. Savant, M.D
- 2025-07-08
Medical Device Reporting/Misbranded
Insightra Medical Inc.
- 2025-06-24
CGMP/QSR/Medical Devices/Adulterated
Aju Pharm Co., Ltd.
- 2025-06-03
CGMP/QSR/Medical Devices/Adulterated
DFI Co., Ltd.
- 2025-05-20
Bioresearch Monitoring Program/Institutional Review Board (IRB)
United Health Products, Inc.
- 2025-04-08
CGMP/QSR/Medical Devices/Adulterated
EpiCare Acquisitions, LLC
- 2025-03-25
Clinical Investigator
Americo F. Padilla, M.D.
See Also (8)
- Quality Management System Information for Certain Premarket Submission Reviews: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- Suggested Format For IDE Progress Report (Status: Final)
- CPG Sec. 300.500 *Reprocessing of Single Use* Devices (Status: Final)
- Medical Device Reporting for User Facilities (Status: Final)
- Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors: Final Guidance for Industry and FDA Staff (Status: Final)
- Sterilized Convenience Kits for Clinical and Surgical Use: Final Guidance for Industry (Status: Final)
- Needlesticks - Medical Device Reporting Guidance for User Facilities, Manufacturers, and Importers (Status: Final)
- Quality System Information for Certain Premarket Application Reviews : Guidance for Industry and FDA Staff (Status: Final)