指导原则库

Third Party Review Guidance for Phacofragmentation System Device Premarket Notification (510(k))

Third Party Review Guidance For Vitreous Aspiration and Cutting Device Premarket Notification (510(k))

官方主题：Premarket,

Guidance for Industry: Exports Under the FDA Export Reform and Enhancement Act of 1996 : Guidance for Industry

Prospective Manufacturers of Barrier Devices Used During Oral Sex for STD Protection

Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers [excimer]

官方主题：Premarket, Investigational Device Exemption (IDE)

Emitted Laser Beam as Emission Indicator for Class II and Class IIIa Laser Products (Laser Notice 49)

Identification Labels for Certain Class I Laser Products (Laser Notice 48)

CPG Sec 110.900 Imported Products - Lack of English Labeling

官方主题：Investigation & Enforcement, Labeling

Variance from Manufacturer Report Number Format - No. 5

官方主题：Postmarket,

CPG Sec. 160.500 Answering Inquiries on Status of Criminal Referrals

官方主题：Investigation & Enforcement,

CPG Sec. 160.750 Drug and Device Products (Including Biologics and Animal Drugs) Found in Violation of GMPRs - Reconditioning

官方主题：Investigation & Enforcement,

Variance from Manufacturer Report Number Format [MDR letter]

官方主题：Adverse Event Reporting System (FAERS),

Effective Visual Control of Laser Projections (Laser Notice 47)

官方主题：Radiological Health

Suggested Format For IDE Progress Report

官方主题：Premarket, Investigational Device Exemption (IDE)

Medical Device Reporting for User Facilities

官方主题：Radiological Health

Thermal Endometrial Ablation Devices (Submission Guidance for an IDE)

官方主题：Premarket,

Hysteroscopes and Gynecology Laparoscopes - Submission Guidance for a 510(k)

官方主题：Premarket, 510(k)

Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities

官方主题：Premarket,

User Instruction for Medical Products (Laser Notice 44)

Hysteroscopic and Laparoscopic Insufflators: Submission Guidance for a 510(k)

官方主题：Premarket,

Guidance Document for the Preparation of Premarket Notification [510(K)] Applications for Exercise Equipment

官方主题：Premarket,

Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices

官方主题：Premarket,

Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles

官方主题：Premarket,

Testing Guidance for Male Condoms Made From New Material (Non-Latex)

官方主题：Premarket,

CPG Sec 100.900 International Memoranda of Understanding

官方主题：Investigation & Enforcement,

Guidance on the Content and Organization of a Premarket Notification for a Medical Laser

官方主题：Premarket, Radiology

Guidance Document for Testing Non-Articulating, 'Mechanically Locked', Modular Implant Components

官方主题：Premarket,

CPG Sec. 390.425 Records and Reports; Applicability - 21 CFR 1002.1

官方主题：Investigation & Enforcement, Records

CPG Sec. 300.400 Contamination of Devices Labeled as Sterile

官方主题：Investigation & Enforcement, Labeling

CPG Sec. 370.100 Cytotoxic Testing for Allergic Diseases

官方主题：Investigation & Enforcement, Clinical Chemistry & Clinical Toxicology

CPG Sec. 393.200 Laser(s) as Medical Devices for Facelift, Wrinkle Removal, Acupuncture, Auricular Stimulation, etc. (CPG 7133.21)

官方主题：Investigation & Enforcement,

CPG Sec. 345.300 Menstrual Sponges

官方主题：Investigation & Enforcement, Physical Medicine

CPG Sec. 355.200 Electrical Muscle Stimulators

官方主题：Investigation & Enforcement,

CPG Sec. 345.100 Condoms; Defects - Criteria for Direct Reference Seizure

官方主题：Investigation & Enforcement, Administrative / Procedural

CPG Sec. 355.300 Ion Generating Devices

官方主题：Investigation & Enforcement, Radiological Health

CPG Sec. 398.350 Regulatory Actions Against Assemblers of X-ray Equipment that Fail to File Reports of Assembly

官方主题：Investigation & Enforcement, Radiology

CPG Sec. 391.200 Warning Statement in Advertisements for High-Intensity Mercury Vapor Discharge Lamps that are not Self-Extinguishing (21 CFR 1040.30(e)(3)*)

官方主题：Investigation & Enforcement, Advertising

CPG Sec. 300.300 Ineffective Devices - 502(f)(I) Labeling Requirements

官方主题：Investigation & Enforcement, Labeling

CPG Sec. 398.600 Certification and Identification of X-ray Components - Sections 1010.2 and 1020.30(e)

官方主题：Investigation & Enforcement,

CPG Sec. 310.100 Pacemaker Reuse

官方主题：Investigation & Enforcement, Cardiovascular