![]() ![]() ![]() |
FDA
Home Page | CDRH Home Page | Search
| CDRH
A-Z Index | Contact CDRH
|
[Federal Register: February 2, 1998 (Volume 63, Number 21)] [Notices] [Page 5387-5393] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr02fe98-84] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 98N-0009] Medical Devices; Exemptions From Premarket Notification and Reserved Devices; Class I AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is publishing a list of class I devices, subject to certain limitations, that will be exempt from premarket notification requirements on February 19, 1998. FDA is also publishing a list of those class I devices that FDA believes will remain subject to premarket notification requirements because they meet the new statutory criteria for premarket notification requirements. These lists do not include class I devices that have been previously exempted by regulation from the premarket notification requirements. FDA is taking this action in order to meet a requirement of the Food and Drug Administration Modernization Act of 1997 (the FDAMA). The agency requests comments on whether the list of class I devices that will remain subject to the premarket notification requirements should be modified. DATES: This notice is effective February 19, 1998. Submit written comments by May 4, 1998. ADDRESSES: Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: Heather S. Rosecrans, Center for Devices and Radiological Health (HFZ-404), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594- 1190. SUPPLEMENTARY INFORMATION: I. Statutory Background Under section 513 of the act (21 U.S.C. 360c), FDA must classify devices into one of three regulatory classes: Class I, class II, or class III. FDA classification of a device is determined by the amount of regulation necessary to provide a reasonable assurance of safety and effectiveness. Under the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 94-295), as amended by the Safe Medical Devices Act of 1990 (Pub. L. 101-629), devices are to be classified into class I (general controls) if there is information showing that the general controls of the act are sufficient to ensure safety and effectiveness; into class II (special controls), if general controls, by themselves, are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide such assurance; and into class III (premarket approval), if there is insufficient information to support classifying a device into class I or class II and the device is a life-sustaining or life-supporting device, or is for a use which is of substantial importance in preventing impairment of human health, or presents a potential unreasonable risk of illness or injury. Most generic types of devices that were on the market before the date of the 1976 amendments (May 28, 1976) (generally referred to as preamendments devices) have been classified by FDA under the procedures set forth in section 513(c) and (d) of the act through the issuance of classification regulations into one of these three regulatory classes. Devices introduced into interstate commerce for the first time on or after May 28, 1976 (generally referred to as postamendments devices) are classified through the premarket notification process under section [[Page 5388]] 510(k) of the act (21 U.S.C. 360(k)). Section 510(k) of the act and the implementing regulations, 21 CFR part 807, require persons who intend to market a new device to submit a premarket notification report containing information that allows FDA to determine whether the new device is substantially equivalent within the meaning of section 513(i) of the act to a legally marketed device that does not require premarket approval. Unless exempted from premarket notification requirements, persons may not market a new device under section 510(k) of the act, unless they receive a substantial equivalence order from FDA or an order reclassifying the device into class I or class II, section 513(i) of the act. On November 21, 1997, the President signed into law the FDAMA (Pub. L. 105-115). Section 206 of the FDAMA, in part, added a new section 510(l) to the act. Under section 501 of the FDAMA, new section 510(l) of the act becomes effective on February 19, 1998. New section 510(l) of the act provides that a class I device is exempt from the premarket notification requirements under section 510(k) of the act, unless the device is intended for a use which is of substantial importance in preventing impairment of human health or it presents a potential unreasonable risk of illness or injury (hereafter ``reserved criteria''). Based on these reserved criteria, FDA has evaluated all class I devices to determine which device types should be subject to premarket notification requirements. In developing the list of reserved devices, the agency considered its experience in reviewing premarket notifications for these device types, focusing on the risk inherent with the device and/or the disease being treated or diagnosed, e.g., devices with rapidly evolving technology or expansions of intended uses. The agency considered the history of adverse event reports under the medical device reporting program for these devices, as well as their history of product recalls. Given the inherent risks with the devices listed and/or the disease or condition being treated or diagnosed, FDA believes that the devices listed as reserved are intended for a use that is of substantial importance in preventing impairment of human health or present a potential unreasonable risk of illness or injury. In this notice, FDA is publishing two lists of devices: (1) A list of the class I devices that FDA believes will be exempt from the premarket notification requirements on February 19, 1998, under section 510(l) of the act, subject to certain limitations from the premarket notification requirements described herein; and (2) a list of the devices that FDA believes fit the reserved criteria under section 510(l) of the act and, therefore, will continue to be subject to premarket notification requirements. These lists do not include class I devices that have been previously exempted by regulation from the premarket notification requirements. FDA believes that class I devices that have previously been exempted generally do not fall within the reserved criteria under section 510(l) of the act. When FDA issues a proposed rule to amend the regulations to codify class I devices that remain subject to the premarket notification requirements, FDA, in limited cases, may propose to revoke the exemption from the premarket notification requirements based on the reserved criteria of section 510(l) of the act. II. Limitations on Exemptions As stated previously, FDA believes that the generic types of class I devices listed herein, in addition to a vast majority of class I devices previously exempted, should be exempt from the premarket notification requirements under section 510(l) of the act. FDA further believes, however, that these generic device categories should be exempt only to the extent that they have existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, for which a misdiagnosis as a result of using the device, would not be associated with high morbidity or mortality. FDA believes that certain changes to devices within a generic type that is generally exempt may make the device intended for a use that is of substantial importance in preventing impairment of human health or may make the device present a potential unreasonable risk of illness or injury. Accordingly, devices changed in this manner would fall within the reserved criteria under section 510(l) of the act and would require premarket notification. FDA believes that devices that have different intended uses than legally marketed devices in that generic type present a potential unreasonable risk of illness or injury because their safety and effectiveness characteristics are unknown. Moreover, FDA believes that in vitro diagnostic devices that are intended for a use, for which a misdiagnosis as a result of using the device, could result in high morbidity or mortality, either are intended for a use that is of substantial importance in preventing impairment of human health or present a potential unreasonable risk of illness or injury. Accordingly, because FDA believes that devices incorporating the characteristics described above fit within the reserved criteria under section 510(l) of the act, FDA considers any class I device to be subject to premarket notification requirements if the device: (1) Has an intended use that is different from the intended use of a legally marketed device in that generic type; e.g., the device is intended for a different medical purpose, or the device is intended for lay use instead of use by health care professionals; or (2) operates using a different fundamental scientific technology than that used by a legally marketed device in that generic type, e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using a deoxyribonucleic acid (DNA) probe or nucleic acid hybridization or amplification technology rather than culture or immunoassay technology; or (3) is a in-vitro device that is intended: (a) For use in the diagnosis, monitoring or screening of neoplastic diseases with the exception of immunohistochemical devices; (b) for use in screening or diagnosis of familial and acquired genetic disorders, including inborn errors of metabolism; (c) for measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy; (d) to assess the risk of cardiovascular diseases; (e) for use in diabetes management; (f) to identify or infer the identity of a microorganism directly from clinical material; (g) for detection of antibodies to microorganisms other than immunoglobulin G (IgG) and IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma; uses noninvasive testing; and (h) for near patient testing (point of care). Class I devices incorporating such changes or modifications are not exempt from premarket notification because FDA believes they meet the reserved criteria described above, under 510(l). In addition to the general limitation on exemptions that FDA considers applicable to all class I devices that is described above, FDA also considers certain devices within a generic class to remain subject to the premarket notification requirements because they [[Page 5389]] either are intended for a use that is of substantial importance in preventing impairment of human health or they present a potential unreasonable risk of illness or injury. For example, FDA, elsewhere in this document, states that it considers liquid bandages generally to be exempt from the premarket notification requirements, but considers a subcategory of those devices, those intended for treatment of burns and other open wounds, to remain subject to the premarket notification requirements. FDA believes that liquid bandages intended for burns and other open wounds should remain subject to this requirement because they are of substantial importance in preventing impairment of human health by helping to prevent infections. FDA advises additionally that an exemption from the requirement of premarket notification does not mean that the device is exempt from any other statutory or regulatory requirements, unless such exemption is explicitly provided by order or regulation. III. Lists of Devices The following devices are devices that FDA believes meet the reserved criteria in section 206 of the FDAMA and, therefore, would remain subject to premarket notification under new section 510(l) added to the act: Table 1.--Reserved Class I Devices ---------------------------------------------------------------------------------------------------------------- 21 CFR Section Name of Device ---------------------------------------------------------------------------------------------------------------- 862.1065.............. Ammonia test system 862.1113.............. Bilirubin (total and unbound) in the neonate test system 862.1410.............. Iron (non-heme) test system 862.1415.............. Iron-binding capacity test system 862.1495.............. Magnesium test system 862.1580.............. Phosphorous (inorganic) test system 862.1660.............. Quality control material (assayed and unassayed)\1\ 862.1680.............. Testosterone test system 862.1775.............. Uric acid test system 862.3110.............. Antimony test system 862.3120.............. Arsenic test system 862.3220.............. Carbon monoxide test system 862.3240.............. Cholinesterase test system 862.3600.............. Mercury test system 864.7040.............. Adenosine triphosphate release assay 864.8950.............. Russell viper venom reagent 864.9050.............. Blood bank supplies 864.9125.............. Vacuum-assisted blood collection system 864.9195.............. Blood mixing devices and blood weighing devices\2\ 866.2390.............. Transport culture medium 866.2560.............. Microbial growth monitor\3\ 866.2850.............. Automated zone reader 866.2900.............. Microbiological specimen collection and transport device 866.3110.............. Campylobacter fetus serological reagents 866.3120.............. Chlamydia serological reagents 866.3235.............. Epstein-Barr virus serological reagents 866.3370.............. Mycobacterium tuberculosis immunofluorescent reagents 866.3870.............. Trypanosoma spp. serological reagents 872.4200.............. Dental handpiece and accessories 872.6250.............. Dental chair and accessories\4\ 872.6640.............. Dental operative unit and accessories\5\ 872.6710.............. Boiling water sterilizer 876.5160.............. Urological clamps for males\6\ 878.4460.............. Surgeon's glove 880.5090.............. Liquid bandage\7\ 880.5680.............. Pediatric position holder 880.6250.............. Patient examination glove 880.6375.............. Patient lubricant 880.6760.............. Protective restraint 882.1030.............. Ataxiagraph 882.1420.............. Electroencephalogram (EEG) signal spectrum analyzer 882.4060.............. Ventricular cannula\8\ 882.4545.............. Shunt system implantation instrument\9\ 884.2980(a)........... Telethermographic system\10\ 884.2982(a)........... Liquid crystal thermographic system\11\ 886.4070.............. Powered corneal burr\12\ 886.4300.............. Intraocular lens guide\13\ 886.4370.............. Keratome 888.1500.............. Goniometer 890.3850.............. Mechanical wheelchair 890.5710.............. Hot or cold disposable packs\14\ 892.1100.............. Scintillation (gamma) camera 892.1110.............. Positron camera ---------------------------------------------------------------------------------------------------------------- \1\ Meets reserved criteria when assayed and unassayed when used for donor screening. \2\ Meets reserved criteria when automated. \3\ Meets reserved criteria when automated blood culturing systems. \4\ Meets reserved criteria when dental chair with the operative unit. \5\ Meets reserved criteria when it is not the accessory tray to the unit. [[Page 5390]] \6\ Meets reserved criteria when devices are for internal use or are used for females. \7\ Meets reserved criteria for uses other than as a skin protectant. \8\ Meets reserved criteria if not made of surgical grade stainless steel. \9\ Meets reserved criteria if not made of surgical stainless steel. \10\ Meets reserved criteria if an adjunct use system. \11\ Meets reserved criteria if nonelectrically powered and AC-powered adjunctive system. \12\ Meets reserved criteria if for use other than for removing rust rings. \13\ Meets reserved criteria if used as folders and injectors for soft or foldable IOL's. \14\ Meets reserved criteria if indicated for use on infants. The following devices are devices that FDA believes do not meet the reserved criteria under section 206 of the FDAMA and, therefore, will be exempt from premarket notification as of February 19, 1998, under new section 510(l) added to the act: Table 2.--Exempted Class I Devices ---------------------------------------------------------------------------------------------------------------- 21 CFR Section Name of Device ---------------------------------------------------------------------------------------------------------------- 862.1030.............. Alanine amino transferase (ALT/SGPT) test system 862.1040.............. Aldolase test system 862.1060.............. Delta-aminolevulinic acid test system 862.1075.............. Androstenedione test system 862.1080.............. Androsterone test system 862.1095.............. Ascorbic acid test system 862.1115.............. Urinary bilirubin and its conjugates (nonquantitative) test system 862.1130.............. Blood volume test system 862.1135.............. C-peptides of proinsulin test system 862.1165.............. Catecholamines (total) test system 862.1175.............. Cholesterol (total) test system 862.1180.............. Chymotrypsin test system 862.1185.............. Compound S (11-deoxycortisol) test system 862.1195.............. Corticoids test system 862.1200.............. Corticosterone test system 862.1240.............. Cystine test system 862.1245.............. Dehydroepiandrosterone (free and sulfate) test system 862.1250.............. Desoxycorticosterone test system 862.1260.............. Estradiol test system 862.1265.............. Estriol test system 862.1270.............. Estrogen (total, in pregnancy) test system 862.1275.............. Estrogens (total, nonpregnancy) test system 862.1280.............. Estrone test system 862.1285.............. Etiocholanolone test system 862.1300.............. Follicle-stimulating hormone test system 862.1310.............. Galactose test system 862.1325.............. Gastrin test system 862.1330.............. Globulin test system 862.1335.............. Glucagon test system 862.1360.............. Gamma-glutamyl transpeptidase and isoenzymes test system 862.1370.............. Human growth hormone test system 862.1375.............. Histidine test system 862.1385.............. 17-Hydroxycorticosteroids (17-ketogenic steroids) test system 862.1390.............. 5-Hydroxyindole acetic acid/serotonin test system 862.1395.............. 17-Hydroxyprogesterone test system 862.1400.............. Hydroxyproline test system 862.1405.............. Immunoreactive insulin test system 862.1430.............. 17-Ketosteroids test system 862.1435.............. Ketones (nonquantitative) test system 862.1450.............. Lactic acid test system 862.1460.............. Leucine aminopeptidase test system 862.1465.............. Lipase test system 862.1475.............. Lipoprotein test system 862.1485.............. Luteinizing hormone test system 862.1500.............. Malic dehydrogenase test system 862.1505.............. Mucopolysaccharides (nonquantitative) test sytem 862.1510.............. Nitrite (nonquantitative) test system 862.1520.............. 5'-Nucleotidase test system 862.1530.............. Plasma oncometry test system 862.1535.............. Ornithine carbamyl transferase test system 862.1540.............. Osmolality test system 862.1542.............. Oxalate test system 862.1550.............. Urinary pH (nonquantitative) test system 862.1560.............. Urinary phenylketones (nonquantitative) test system 862.1570.............. Phosphohexose isomerase test system 862.1590.............. Porphobilinogen test system 862.1595.............. Porphyrins test system 862.1605.............. Pregnanediol test system [[Page 5391]] 862.1610.............. Prenanetriol test system 862.1615.............. Pregnenolone test system 862.1620.............. Progesterone test system 862.1625.............. Prolactin (lactogen) test system 862.1630.............. Protein (fractionation) test system 862.1645.............. Urinary protein or albumin (nonquantitative) test system 862.1650.............. Pyruvate kinase test system 862.1655.............. Pyruvic acid test system 862.1660.............. Quality control material (assayed and unassayed)\1\ 862.1705.............. Triglyceride test system 862.1725.............. Trypsin test system 862.1730.............. Free tyrosine test system 862.1780.............. Urinary calculi (stones) test system 862.1785.............. Urinary urobilinogen (nonquantitative) test system 862.1790.............. Uroporphyrin test system 862.1795.............. Vanilmandelic acid test system 862.1805.............. Vitamin A test system 862.1820.............. Xylose test system 862.2140.............. Centrifugal chemistry analyzer for clinical use 862.2150.............. Continuous flow sequential multiple chemistry analyzer for clinical use 862.2160.............. Discrete photometric chemistry analyzer for clinical use 862.2170.............. Micro chemistry analyzer for clinical use 862.2250.............. Gas liquid chromatography system for clinical use 862.2260.............. High pressure liquid chromatography system for clinical use 862.2270.............. Thin-layer chromatography system for clinical use 862.2300.............. Colorimeter photometer, or spectrophotometer for clinical use 862.2400.............. Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use 862.2500.............. Enzyme analyzer for clinical use 862.2540.............. Flame emission photometer for clinical use 862.2560.............. Fluorometer for clinical use 862.2680.............. Microtitrator for clinical use 862.2700.............. Nephelometer for clinical use 862.2730.............. Osmometer for clinical use 862.2750.............. Pipetting and diluting system for clinical use 862.2850.............. Atomic absorption spectrophotometer for clinical use 862.2860.............. Mass spectrometer for clinical use 862.2900.............. Automated urinalysis system 862.3280.............. Clinical toxicology control material 864.2280.............. Cultured animal and human cells 864.5240.............. Automated blood cell diluting apparatus 864.9185.............. Blood grouping view box 864.9195.............. Blood mixing devices and blood weighing devices\2\ 864.9225.............. Cell-freezing apparatus and reagents for in vitro diagnostic use 864.9275.............. Blood bank centrifuge for in vitro diagnostic use 864.9320.............. Copper sulphate solution for specific gravity determination 864.9750.............. Heat-sealing device 866.2660.............. Microorganism differentiation and identification device 866.3040.............. Aspergillus spp. serological reagents 866.3140.............. Corynebacterium spp. serological reagents 866.3145.............. Coxsackievirus serological reagents 866.3200.............. Echinococcus spp. serological reagents 866.3240.............. Equine encephalomyelitis virus serological reagents 866.3355.............. Listeria spp. serological reagents 866.3360.............. Lymphocytic choriomeningitis virus serological reagents 866.3375.............. Mycoplasma spp. serological reagents 866.3380.............. Mumps virus serological reagents 866.3405.............. Poliovirus serological reagents 866.3480.............. Respiratory syncytial virus serological reagents 866.3500.............. Rickettsia serological reagents 866.3600.............. Schistosoma spp. serological reagents 866.3680.............. Sporothrix scheneckii serological reagents 866.3740.............. Streptococcus spp. serological reagents 866.3850.............. Trichinella spiralis serological reagents 866.5060.............. Prealbumin immunological test system 866.5065.............. Human allotypic marker immunological test system 866.5160.............. Beta-globulin immunological test system 866.5200.............. Carbonic anhydrase B and C immunological test system 866.5330.............. Factor XIII, A, S, immunological test system\3\ 866.5400.............. Alpha-globulin immunological test system 866.5420.............. Alpha-I-glycoproteins immunological test system 866.5425.............. Alpha-2-glycoproteins immunological test system 866.5430.............. Beta-2-glycoprotein I immunological test system [[Page 5392]] 866.5440.............. Beta-2-glycoprotein III immunological test system 866.5560.............. Lactic dehydrogenase immunological test system 866.5570.............. Lactoferrin immunological test system 866.5590.............. Lipoprotein X immunological test system 866.5715.............. Plasminogen immunological test system 866.5735.............. Prothrombin immunological test system\4\ 866.5765.............. Retinol-binding protein immunological test system 866.5890.............. Inter-alpha trypsin inhibitor immunological test system 868.1910.............. Esophageal stethoscope 868.5620.............. Breathing mouthpiece 868.5640.............. Medicinal nonventilatory nebulizer (atomizer) 868.5675.............. Rebreathing device 868.5700.............. Nonpowered oxygen tent 868.6810.............. Tracheobronchial suction catheter 872.3400(b)(1)........ Karaya and sodium borate with or without acacia denture adhesive 874.1070.............. Short increment sensitivity index (SISI) adapter 874.1500.............. Gustometer 874.1800.............. Air or water caloric stimulator 874.1925.............. Toynbee diagnostic tube 874.3300(b)(1)........ Hearing aid\5\ 874.4100.............. Epistaxis balloon 874.5300.............. Ear, nose, and throat examination and treatment unit 874.5550.............. Powered nasal irrigator 874.5840.............. Antistammering device 876.5160.............. Urological clamps for males\6\ 876.5210.............. Enema kit 876.5250(b)(2)........ Urine collector and accessories 878.4040.............. Surgical apparel\7\ 878.4200.............. Introduction/drainage catheter and accessories 878.4320.............. Removable skin clip 878.4680.............. Nonpowered, single patient, portable suction apparatus 878.4760.............. Removable skin staple 878.4820.............. Surgical instrument motors and accessories/attachments 878.4960.............. Operating tables and accessories and operating chair and accessories 880.5090.............. Liquid bandage\8\ 880.5270.............. Neonatal eye pad 880.5420.............. Pressure infusor for an I.V. bag 882.4060.............. Ventricular cannula\9\ 882.4545.............. Shunt system implantation instrument\10\ 882.4650.............. Neurosurgical suture needle 882.4750.............. Skull punch\11\ 884.1040.............. Viscometer for cervical mucus 886.1350.............. Keratoscope\12\ 886.1780.............. Retinoscope\13\ 886.1940.............. Tonometer sterilizer 886.4070.............. Powered corneal burr\14\ 886.4300.............. Intraocular lens guide\15\ 886.5850.............. Sunglasses (nonprescription) 890.5180.............. Manual patient rotation bed 890.5710.............. Hot or cold disposable pack\16\ 892.1300.............. Nuclear rectilinear scanner 892.1320.............. Nuclear uptake probe 892.1330.............. Nuclear whole body scanner 892.1410.............. Nuclear electrocardiograph synchronizer 892.1890.............. Radiographic film illuminator 892.1910.............. Radiographic grid 892.1960.............. Radiographic intensifying screen 892.1970.............. Radiographic ECG/respirator, synchronizer 892.5650.............. Manual radionuclide applicator system ---------------------------------------------------------------------------------------------------------------- \1\ Exemption is limited to unassayed material, except when used in conjunction with donor screening tests. \2\ Exemption is limited to manual devices. \3\ This exemption should not be confused with Sec. 864.7290. \4\ This exemption should not be confused with Secs. 864.5425 or 864.7750. \5\ Exemption is limited to air-conduction hearing aids. \6\ Exemption does not include devices for internal use or devices used for females. \7\ Exemption is limited to class I category other than surgical gowns and surgical masks. \8\ Exemption is limited to uses as a skin protectant. \9\ Exemption is limited to surgical grade stainless steel. \10\ Exemption is limited to devices made of surgical grade stainless steel. \11\ Exemption should not be confused with Sec. 882.4305. \12\ Exemption is extended to those with software. \13\ Exemption is limited to class I battery-powered devices. \14\ Exemption is limited to rust ring removal. [[Page 5393]] \15\ Exemption does not apply if used as folders and injectors for soft or foldable IOL's. \16\ Exemption does not apply when indicated for infants. IV. Comments Interested persons may, on or before May 4, 1998, submit to the Dockets Management Branch (address above) written comments regarding the notice. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday. Dated: January 23, 1998. William B. Schultz, Deputy Commissioner for Policy. [FR Doc. 98-2498 Filed 1-30-98; 8:45 am] BILLING CODE 4160-01-F
Updated 2/2/1998
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH