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FDA新增1003种II类医疗器械的上市前通告豁免

阅读: 2017年07月13日



基于产品能够满足安全有效的原则,FDA新增1003种器械可以豁免上市前通告(Exempt from 510(k) premarket notification)的要求。根据[21世纪治愈法案]已于今年3月发布了草案,旨在减轻法规负担和降低企业成本。


然而豁免510(k)并非意味着其他法规要求也得到豁免,除非有相关的法规条令明确提出可以豁免,例如GMP生产要求,包装和标签以及列名的要求等。


正在受理中的510(k)若在此次豁免目录中,则需要与FDA做进一步沟通以确认豁免规则是否适用于该器械,否则该510(k)的申请需要继续进行下去。


申请方已具有510(k)的器械,而该器械又符合此次豁免要求,则不需要采取任何行动,若该器械只是部分符合豁免要求,则需要进一步明确该特定器械最终豁免与否。


同时,FDA针对部分豁免的器械新增了产品代码,申请方需要评估是继续沿用原先代码还是改为新增的代码,以及衍生而来的列名相关事项也需引起关注。


以下为此次新增的II类器械豁免510(k)要求的目录:


21 CFR section

Device type

Product  code

862.1020

Acid  Phosphatase, Nitrophenylphosphate.

CJN

862.1020

Acid  Phosphatase, Thymol Blue Monophosphate.

CJR

862.1020

Acid  Phosphatase, Disodium Phenylphosphate.

CJX

862.1020

Acid Phosphatase, Naphthyl Phosphate

CKB

862.1020

Acid  Phosphatase, Thymolphthale Inmonophosphate.

CKE

862.1020

Acid  Phosphatase, Beta Glycerophosphate

CKH

862.1020

Acid  Phosphatase (Prostatic), Tartrate Inhibited

JFH

862.1090

Radioassay,  Angiotensin Converting Enzyme.

KQN

862.1100

Vanillin Pyruvate, AST/SGOT

CIF

862.1100

Diazo, AST/SGOT

CIQ

862.1100

Hydrazone Colorimetry, AST/SGOT

CIS

862.1100

NADH  Oxidation/NAD Reduction, AST/SGOT.

CIT

862.1150

Calibrator, Primary

JIS

862.1150

Calibrator, Secondary

JIT

862.1150

Calibrator, Surrogate

JIW

862.1150

Calibrator, Multi-Analyte Mixture

JIX

862.1345

Drink, Glucose Tolerance

MRV

862.1350

Continuous  Glucose Monitor Secondary Display.

PJT

862.1445

Chromatographic  Separation, Lactate Dehydrogenase Isoenzymes.

CEX

862.1445

Electrophoretic,  Lactate Dehydrogenase Isoenzymes

CFE

862.1445

Differential  Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes

JGF

862.1509

System,  Test, Urinary Methylmalonic Acid

LPT

862.1685

Radioimmunoassay,  Thyroxine-Binding Globulin.

CEE

862.1700

Radioimmunoassay, Total Thyroxine

CDX

862.1700

Enzyme  Immunoassay, Non-Radiolabeled, Total Thyroxine.

KLI

862.2265

High Throughput DNA Sequence Analyzer.

PFF

862.2570

Instrumentation  For Clinical Multiplex Test Systems.

NSU

862.2570

Real  Time Nucleic Acid Amplification System.

OOI

862.2570

Mass  Spectrometer For Clinical Multiplex Test Systems

OTA

862.2570

Micro Total Analysis Instrument System.

OUE

862.2570

Complete  Gene Expression Profiling Accessory Reagents

OVA

862.2570

DNA  Genetic Analyzer

PCA

862.2570

Data  Acquisition Software

PQQ

862.3100

Enzyme  Immunoassay, Amphetamine.

DKZ

862.3100

Radioimmunoassay,  Amphetamine

DJP

862.3100

Thin  Layer Chromatography, Amphetamine.

DIT

862.3100

Gas  Chromatography, Amphetamine

DOD

862.3100

Liquid  Chromatography, Amphetamine.

DNI

862.3150

Enzyme  Immunoassay, Barbiturate

DJL

862.3150

Enzyme  Immunoassay, Barbiturate

DIS

862.3150

Radioimmunoassay,  Barbiturate

DKN

862.3150

Thin  Layer Chromatography, Barbiturate.

DKX

862.3150

Mercury  Dithiazone, Colorimetry, Barbiturate.

DJN

862.3150

Hemagglutination  Inhibition, Barbiturate.

DLX

862.3150

Gas  Liquid Chromatography, Barbiturate.

DMF

862.3150

High  Pressure Liquid Chromatography, Barbiturate

KZY

862.3170

Enzyme  Immunoassay, Benzodiazepine

JXM

862.3170

High  Pressure Liquid Chromatography, Benzodiazepine.

LAA

862.3170

Test,  Benzodiazepine, Over The Counter

NFV

862.3170

Gas  Chromatography, Benzodiazepine.

KZZ

862.3170

Thin  Layer Chromatography, Benzodiazepine.

LAB

862.3200

Calibrators,  Drug Mixture

DKB

862.3200

Calibrators,  Drug Specific

DLJ

862.3200

Calibrators,  Ethyl Alcohol

DNN

862.3250

Enzyme  Immunoassay, Cocaine and Cocaine Metabolites

DIO

862.3250

Radioimmunoassay,  Cocaine Metabolite.

KLN

862.3250

Enzyme  Immunoassay, Cocaine

JXO

862.3250

Hemagglutination,  Cocaine Metabolites (Benzoylecgonine).

DLN

862.3250

Thin  Layer Chromatography, Cocaine.

DMN

862.3250

Free  Radical Assay, Cocaine

DIR

862.3250

Gas Chromatography,  Cocaine

DIN

862.3250

Thin  Layer Chromatography, Benzoylecgonine.

DOM

862.3250

High  Pressure Liquid Chromatography, Cocaine and Cocaine Metabolites

LAC

862.3270

High  Pressure Liquid Chromatography, Codeine.

LAE

862.3270

Thin  Layer Chromatography, Codeine.

DLD

862.3270

Gas  Chromatography, Codeine

LAD

862.3580

Radioimmunoassay,  LSD (125–I)

DLB

862.3580

Free  Radical Assay, LSD

DOL

862.3610

Gas  Chromatography, Methamphetamine

LAF

862.3610

Thin  Layer Chromatography, Methamphetamine.

DJC

862.3610

High  Pressure Liquid Chromatography, Methamphetamine

LAG

862.3610

Test,  Methamphetamine, Over The Counter.

NGG

862.3620

Enzyme  Immunoassay, Methadone

DJR

862.3620

Hemagglutination  Inhibition, Methadone.

DIW

862.3620

Gas  Chromatography, Methadone

DMB

862.3620

Thin  Layer Chromatography, Methadone.

DKR

862.3620

Liquid  Chromatography, Methadone

DNT

862.3620

Free  Radical Assay, Methadone

DPP

862.3630

Radioimmunoassay,  Methaqualone

KXS

862.3640

Thin  Layer Chromatography, Morphine.

DNK

862.3640

Radioimmunoassay,  Morphine (123–I), Goat Antibody Ammonium Sulfate Sep.

DOE

862.3640

Fluorometry,  Morphine

DJJ

862.3640

Liquid  Chromatography, Morphine

DPK

862.3640

Gas  Chromatography, Morphine

DMY

862.3640

Hemagglutination  Inhibition, Morphine.

DLR

862.3640

Free  Radical Assay, Morphine

DOK

862.3640

Radioimmunoassay,  Morphine (3–H), Goat Antibody Ammonium Sulfate Sep.

DIQ

862.3640

Radioimmunoassay,  Morphine-Barbiturate (125–I), Goat Antibody.

DNA

862.3650

Enzyme  Immunoassay, Opiates

DJG

862.3650

Gas  Chromatography, Opiates

DJF

862.3650

Hemagglutination,  Opiates

DLT

862.3650

Thin  Layer Chromatography, Opiates

LAI

862.3650

Free  Radical Assay, Opiates

DKT

862.3650

High  Pressure Liquid Chromatography, Opiates

LAH

862.3700

Enzyme  Immunoassay, Propoxyphene.

JXN

862.3700

Thin  Layer Chromatography, Propoxyphene

DPN

862.3700

Gas  Chromatography, Propoxyphene

LAJ

862.3700

High  Pressure Liquid Chromatography, Propoxyphene

LAK

862.3870

Enzyme  Immunoassay, Cannabinoids.

LDJ

862.3870

Reagents,  Test, Tetrahydrocannabinol.

DKE

862.3870

Radioimmunoassay,  Cannabinoid(S)

LAT

862.3910

High  Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs.

LFI

862.3910

U.V.  Spectrometry, Tricyclic Antidepressant Drugs.

LFH

862.3910

Thin Layer  Chromatography, Tricyclic Antidepressant Drugs.

MLK

864.5400

Fibrometer

GIE

864.5400

Timer,  Coagulation

JBT

864.5425

Control,  Plasma, Abnormal

GGC

864.5425

Plasma,  Coagulation Control

GGN

864.5425

Plasma,  Control, Normal

GIZ

864.6550

Control,  Fecal Occult Blood

OSL

864.6650

Study,  Platelet Adhesive

JBZ

864.7275

Test,  Euglobulin Lysis

JBO

864.7300

Fibrin  Monomer Paracoagulation

JBN

864.7340

Fibrinogen  Standard

GFX

864.7340

Plasma,  Fibrinogen Control

GIL

864.7375

Glutathione,  Red-Cell

GII

864.7375

Fluorescence,  Visual Observation (Qual., U.V.), Glutathione Reductase.

JMH

864.7375

Assay,  Glutathione Reductase

KQF

864.7415

Control,  Hemoglobin, Abnormal

JCM

864.7455

Stain,  Fetal Hemoglobin

GHQ

864.7500

Acid  Hematin

GGF

864.7720

Test, Prothrombin  Consumption

GGQ

864.7735

Prothrombin-Proconvertin  and Thrombotest

JPF

864.8150

Calibrator  for Cell Indices

KRX

864.8165

Calibrator  for Hemoglobin and Hematocrit Measurement

KRZ

864.8175

Calibrator  for Platelet Counting

KRY

864.8185

Calibrator  for Red-Cell and White-Cell Counting

KSA

864.8625

Standards  and Controls, Hemoglobin, Normal and Abnormal.

GFS

864.8625

Control,  White-Cell

GGL

864.8625

Control,  Hemoglobin

GGM

864.8625

Control,  Platelet

GJP

864.8625

Control,  Red-Cell

GJR

864.8625

Control,  Hematocrit

GLK

864.8625

Mixture,  Control, White-Cell and Red-Cell Indices.

GLQ

864.8625

Control,  Cell Counter, Normal and Abnormal.

JCN

864.8625

Mixture,  Hematology Quality Control

JPK

864.8625

Material,  Quality Control, Semen Analysis

NRF

864.8625

Control  Material, Blood Circulating Epithelial Cancer Cell.

NRS

864.9400

Solution,  Stabilized Enzyme

KSK

866.3395

Norovirus  Serological Reagents

OUC

866.5210

Immunochemical,  Ceruloplasmin

CHN

866.5210

Ceruloplasmin,  Rhodamine, Antigen, Antiserum, Control.

DCT

866.5210

Ceruloplasmin,  FITC, Antigen, Antiserum, Control

DCY

866.5210

Ceruloplasmin,  Antigen, Antiserum, Control.

DDB

866.5210

P-Phenyl-Enediamine/EDTA  (Spectrophotometric), Ceruloplasmin.

JFQ

866.5210

Indirect  Copper Assay, Ceruloplasmin.

JFR

866.5470

Hemoglobin,  Chain Specific, Antigen, Antiserum, Control

DAM

866.5620

Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control.

DDT

866.5620

Alpha-2-Macroglobulin, FITC, Antigen, Antiserum, Control

DDY

866.5620

Alpha-2-Macroglobulin, Antigen, Antiserum, Control.

DEB

866.5630

System,  Test, Beta-2-Microglobulin Immunological

JZG

866.5750

System,  Test, Radioallergosorbent (RAST) Immunological.

DHB

866.5910

Quality  Control Material, Genetics, DNA.

NZB

868.1040

Algesimeter,  Powered

BSI

868.1400

Legging,  Compression, Non-Inflatable.

LLK

868.2385

Analyzer,  Nitrogen Dioxide

MRQ

868.2500

Monitor,  Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia

KLK

868.2500

Monitor,  Oxygen, Cutaneous, For Uses Other Than For Infant Not

Under  Gas Anesthesia.

LPP

868.2550

Pneumotachometer

JAX

868.5180

Bed,  Rocking, Breathing Assist

CCO

868.6250

Compressor,  Air, Portable

BTI

870.1330

Wire,  Guide, Catheter

DQX

870.1390

Trocar

DRC

870.1650

Syringe,  Balloon Inflation

MAV

870.1875

Lung  Sound Monitor

OCR

870.2675

Oscillometer

DRZ

870.2770

Analyzer,  Body Composition

MNW

870.4280

Filter,  Prebypass, Cardiopulmonary Bypass.

KRJ

870.4290

Adaptor,  Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

DTL

870.4340

Monitor  and/or Control, Level Sensing, Cardiopulmonary Bypass.

DTW

870.4400

Reservoir,  Blood, Cardiopulmonary Bypass.

DTN

870.4420

Sucker,  Cardiotomy Return, Cardiopulmonary Bypass

DTS

870.4430

Suction  Control, Intracardiac, Cardiopulmonary Bypass

DWD

872.1720

Tester,  Pulp

EAT

872.3260

External  Cleaning Solution

PME

872.3300

Coating,  Denture Hydrophilic, Resin

EBE

872.3540

Pad,  Denture, Over The Counter

EHR

872.3540

Cushion,  Denture, Over The Counter

EHS

872.3560

Reliner,  Denture, Over The Counter

EBP

872.3590

Denture,  Plastic, Tooth

ELM

872.3600

Denture  Preformed (Partially Prefabricated Denture).

EKO

872.3890

Splint,  Endodontic Stabilizing

ELS

872.5550

Ring,  Teething, Fluid-Filled

KKO

872.6770

Syringe,  Cartridge

EJI

874.1090

Tester,  Auditory Impedance

ETY

874.1090

Tympanometer

NAS

874.1120

Generator,  Electronic Noise (for Audiometric Testing).

ETS

874.1325

Electroglottograph

KLX

874.3310

Calibrator,  Hearing Aid/Earphone and Analysis Systems

ETW

874.3320

Hearing  Aid, Group and Auditory Trainer.

EPF

874.3320

Device,  Assistive Listening

LZI

874.3330

Hearing  Aid, Master

KHL

874.3430

Mold,  Middle-Ear

ETC

874.3730

Device,  Voice Amplification

MCK

876.1500

Endoscopic  Magnetic Retriever

FCC

876.1500

Light  Source, Incandescent, Diagnostic.

FCQ

876.1500

Light  Source, Photographic, Fiberoptic

FCR

876.1500

Light  Source, Fiberoptic, Routine

FCW

876.1500

Carrier,  Sponge, Endoscopic

FGS

876.1500

Light  Source, Endoscope, Xenon Arc

GCT

876.1500

Transformer,  Endoscope

GCW

876.1500

Scissors  For Cystoscope

KGD

876.1500

LED  Light Source

NTN

876.1500

Endoscopic  Guide Wire, Gastroenterology-Urology.

OCY

876.1500

Endoscopic  Grasping/Cutting Instrument, Non-Powered

OCZ

876.4020

Light,  Catheter, Fiberoptic, Glass, Ureteral.

FCS

876.4270

Rod, Colostomy

EZP

876.4400

Ligator,  Hemorrhoidal

FHN

876.4400

Ligator,  Esophageal

MND

876.4500

Lithotriptor,  Biliary Mechanical

LQC

876.4770

Urethrotome

EZO

876.5010

Bag,  Bile Collecting

EXF

876.5010

Catheter,  Biliary, Surgical

GCA

876.5025

Vibrator  for Climax Control of Premature Ejaculation

PIA

876.5365

Dilator,  Esophageal (Metal Olive) Gastro-Urology

EZM

876.5365

Bougie,  Esophageal, and Gastrointestinal, Gastro-Urology.

FAT

876.5365

Dilator,  Esophageal

KNQ

876.5520

Dilator,  Urethral

KOE

876.5630

Catheter,  Peritoneal, Long-Term Indwelling

FJS

876.5630

Catheter,  Peritoneal Dialysis, Single Use.

FKO

876.5630

System,  Peritoneal, Automatic Delivery.

FKX

876.5665

Disinfectant,  Subsystem, Water Purification.

NIH

876.5820

Set,  Dialyzer Holder

FKI

876.5895

Irrigator,  Ostomy

EXD

876.5980

Catheter,  Retention, Barium Enema With Bag.

FGD

876.5980

Gastrostomy  Tube Holder

PLI

878.4370

Drape,  Surgical, ENT

ERY

878.4370

Drape,  Pure Latex Sheet, With Self-Retaining Finger Cot

EYX

878.4370

Drape,  Urological, Disposable

EYY

878.4370

Pad,  Kelly

FNW

878.4370

Drape,  Patient, Ophthalmic

HMT

878.4370

Drape,  Microscope, Ophthalmic

HMW

878.4370

Ring  (Wound Protector), Drape Retention, Internal.

KGW

878.4370

Drape,  Surgical

KKX

878.4495

Suture,  Nonabsorbable, Steel, Monofilament And Multifilament, Sterile.

GAQ

878.4580

Lamp,  Operating-Room

FQP

878.4580

Light,  Surgical, Instrument

FSQ

878.4580

Light,  Surgical, Floor Standing

FSS

878.4580

Light,  Surgical, Endoscopic

FSW

878.4580

Light,  Surgical, Connector

FSX

878.4580

Light,  Surgical, Ceiling Mounted

FSY

878.4580

Light,  Surgical, Carrier

FSZ

878.4580

Light,  Surgical, Accessories

FTA

878.4580

Lamp,  Surgical

FTD

878.4580

Illuminator,  Remote

FTG

878.4580

Lamp,  Surgical, Incandescent

GBC

878.5070

Apparatus,  Air Handling, Bench

FZG

878.5070

Apparatus,  Air Handling, Room

FZH

878.5070

Apparatus,  Air Handling, Enclosure

FZI

880.5580

Locator,  Acupuncture Point

BWJ

880.5580

Needle,  Acupuncture, Single Use

MQX

880.5780

Stocking,  Medical Support (to Prevent Pooling of Blood in Legs).

DWL

882.1020

Analyzer,  Rigidity

GZM

882.1470

Computerized  Cognitive Assessment Aid.

PKQ

882.1540

Device,  Galvanic Skin Response Measurement

GZO

882.1560

Device,  Skin Potential Measurement

HCJ

882.1855

Encephalogram  Telemetry System

GYE

882.5895

Vibratory  Counter-Stimulation

OVP

884.1630

Colposcope  (and Colpomicroscope)

HEX

884.2990

Sheet,  Recording, Breast Examination.

NHM

884.3200

Drain,  Cervical

HFL

884.4400

Forceps,  Obstetrical

HDA

884.4530

Tenaculum,  Uterine

HDC

884.4530

Clamp,  Umbilical

HFW

884.4530

Speculum,  Vaginal, Nonmetal

HIB

884.4530

Speculum,  Vaginal, Nonmetal, Fiberoptic

HIC

884.4530

Clamp  and Cutter, Umbilical

NBZ

884.4900

Table,  Obstetrical, AC-Powered (and Accessories).

HDD

884.4900

Table,  Obstetrical, Manual (and Accessories).

HHP

884.4900

Table,  Obstetric (and Accessories)

KNC

884.5200

Hemorrhoid  Prevention Pressure Wedge.

OOA

884.5390

Heater,  Perineal, Direct Contact

HGZ

884.5390

Heater,  Perineal, Radiant, Non-Contact.

HHA

884.5390

Heater,  Perineal

KND

884.5400

Cup,  Menstrual

HHE

884.5425

Pad,  Menstrual, Scented

HHL

884.6120

Accessory,  Assisted Reproduction

MQG

884.6130

Microtools,  Assisted Reproduction (Pipettes).

MQH

884.6150

Micromanipulators  and Microinjectors, Assisted Reproduction.

MQJ

884.6160

Labware,  Assisted Reproduction

MQK

886.1120

Photorefractor

MMF

886.1120

Camera,  Ophthalmic, General-Use

PJZ

886.1250

Euthyscope,  AC-Powered

HMK

886.1570

Ophthalmoscope,  AC-Powered

HLI

886.1570

Ophthalmoscope,  Battery-Powered

HLJ

886.1570

Ophthalmoscopes,  Replacement Batteries, Hand-Held.

MSG

886.1780

Retinoscope, AC-Powered

HKL

886.1850

Biomicroscope,  Slit-Lamp, AC-Powered

HJO

886.1945

Transilluminator,  AC-Powered

HJM

886.3320

Ocular  Peg

MQU

886.4150

Tubing,  Replacement, Phacofragmentation Unit

MSR

886.4250

Unit,  Electrolysis, AC-Powered, Ophthalmic

HRO

886.4335

Headlight,  Fiberoptic Focusing

FCT

886.4335

Light,  Headband, Surgical

FSR

886.4335

Headlamp,  Operating, AC-Powered

HPQ

886.4400

Locator,  Metal, Electronic

HPM

886.4440

Magnet,  AC-Powered

HPO

886.4790

Sponge,  Ophthalmic

HOZ

886.4790

Eye  Tray

OJK

888.1240

Dynamometer,  AC-Powered

LBB

888.4580

Instrument,  Surgical, Sonic and Accessory/Attachment

JDX

888.4580

System,  Cement Removal Extraction

LZV

890.1450

Hammer,  Reflex, Powered

IKO

890.5100

Bath,  Hydro-Massage

ILJ

890.5100

Bath,  Sitz, Powered

ILM

890.5110

Bath,  Paraffin

IMC

890.5250

Cabinet,  Moist Steam

IMB

890.5360

Exerciser,  Measuring

ISD

890.5500

Lamp, Infrared,  Therapeutic Heating

ILY

890.5575

Device,  Warning, Overload, External Limb, Powered.

IRN

892.1000

MRI  Disposable Kit

OIM

892.1560

Biopsy  Needle Guide Kit

OIJ

892.1610

Aperature,  Radiographic

IZS

892.1610

Cone,  Radiographic

IZT

892.1610

Collimator,  Automatic, Radiographic

IZW

892.1610

Collimator,  Manual, Radiographic

IZX

892.1610

Device,  Beam Limiting, X-Ray, Diagnostic.

KPW

892.1650

Arthrogram  Tray

OII

892.1650

Radiology  Dental Tray

OIK

892.1670

Device,  Spot-Film

IXL

892.1680

Radiographic  Contrast Tray

OIO

892.1680

Radiology  Diagnostic Kit

OIP

892.1730

Discography  Kit

OIL

892.1820

Chair,  Pneumocephalographic

HBK

892.1850

Cassette,  Radiographic Film

IXA

892.1860

Changer,  Radiographic Film/Cassette

KPX

892.1870

Programmer,  Changer, Film/Cassette, Radiographic

IZP

892.1900

Controller,  Temperature, Radiographic.

EGT

892.1900

Dryer,  Film, Radiographic

EGW

892.1900

Processor,  Radiographic-Film, Automatic, Dental.

EGY

892.1900

Processor,  Radiographic-Film, Automatic.

IXW

892.1900

Processor, Cine Film

IXX

892.2030

Digitizer,  Image, Radiological

LMA

892.2030

Digitizer,  Images, Ophthalmic

NFH

892.2040

Camera,  Multi Format, Radiological

LMC

892.2040

Device,  Hardcopy, Images, Ophthalmic.

NFI

892.5730

Prostate  Seeding Kit

OIN



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