patient notifications should the certifi- rective action, FDA determines that a cation agency determine that mam- certification agency has demonstrated mography quality has been com willful disregard for public health, has promised to such an extent that it may committed fraud, has failed to provide present a serious risk to human health. adequate resources for the program,

(h) Electronic data transmission. There has submitted material false stateshall be processes to ensure the timeli- ments to the agency, has failed to ness and accuracy of electronic trans achieve the MQSA goals of quality mission of inspection data and facility mammography and access, or has percertification status information in a formed or failed to perform a delegated format and timeframe determined by function in a manner that may canse FDA.

serious risk to human health, FDA (i) Changes to standards. A certifi may withdraw its approval of that cercation agency shall obtain FDA au tification agency. The certification thorization for any changes it proposes agency shall notify, within a time pe to make in any standard that FDA has riod and in a manner approved by FDA previously accepted under $900.21 be- all facilities certified or seeking cerfore requiring facilities to comply with tification by it that it has been rethe changes as a condition of obtaining quired to correct major deficiencies. or maintaining certification.

(1) FDA shall notify the certification

agency of FDA's action and the 8 900.23 Evaluation.

grounds on which the approval was FDA shall evaluate annually the per- withdrawn. formance of each certification agency. (2) A certification agency that has The evaluation shall include the use of lost its approval shall notify facilities performance indicators that address certified or seeking certification by it, the adequacy of program performance as well as the appropriate accreditain certification, inspection, and en tion bodies with jurisdiction in the forcement activities. FDA will also State, that its approval has been withconsider any additional information drawn. Such notification shall be made deemed relevant by FDA that has been within a timeframe and in a manner provided by the certification body or approved by FDA. other sources or has been required by (b) Minor deficiencies. If FDA deterFDA as part of its oversight mandate. mines that a certification agency has The evaluation also shall include a re demonstrated deficiencies in perview of any changes in the standards or forming certification functions and reprocedures in the areas listed in sponsibilities that are less serious of 88 900.21(b) and 900.22 that have taken more limited than the deficiencies in place since the original application or paragraph (a) of this section, including the last evaluation, whichever is most failure to follow the certification ageirecent. The evaluation shall include a cy's own procedures and policies as ap determination of whether there are proved by FDA, FDA shall notify the major deficiencies in the certification certification agency that it has a spec agency's regulations or performance fied period of time to take particular that, if not corrected, would warrant corrective measures as directed by withdrawal of the approval of the cer FDA or to submit to FDA for approval tification agency under the provisions the certification agency's own plan of of $900.24, or minor deficiencies that corrective action addressing the minor would require corrective action.

deficiencies. If the approved corrective

actions are not being implemented sat$ 900.24 Withdrawal of approval.

isfactorily or within the established If FDA determines, through the eval schedule, FDA may place the agency uation activities of $900.23, or through on probationary status for a period of other means, that a certification agen time determined by FDA, or may withcy is not in substantial compliance draw approval of the certification with this subpart, FDA may initiate agency. the following actions:

(1) If FDA places a certification agen(a) Major deficiencies. If, after pro- cy on probationary status, the certifividing notice and opportunity for cor- cation agency shall notify all facilities

rtified or seeking certification by it timeframe and in a manner approved ? its probationary status within a by FDA. me period and in a manner approved (c) Transfer of records. A certification 7 FDA.

agency that has its approval with(2) Probationary status shall remain drawn shall transfer facility records effect until such time as the certifi

and other related information as reition agency can demonstrate to the

quired by FDA to a location and actisfaction of FDA that it has success

cording to a schedule approved by lly implemented or is implementing

FDA. le corrective action plan within the

$ 900.25 Hearings and appeals. tablished schedule, and that the cor

(a) Opportunities to challenge final ictive actions have substantially iminated all identified problems, or

adverse actions taken by FDA regard

ing approval of certification agencies (3) If FDA determines that a certifi

or withdrawal of approval of certifiition agency that has been placed on

cation agencies shall be communicated robationary status is not imple

through notices of opportunity for inlenting corrective actions satisfac

formal hearings in accordance with srily or within the established sched

part 16 of this chapter. le, FDA may withdraw approval of the

(b) A facility that has been denied ertification agency. The certification

certification is entitled to an appeals gency shall notify all facilities cer process from the certification agency. fied or seeking certification by it, as The appeals process shall be specified ell as the appropriate accreditation in writing by the certification agency odies with jurisdiction in the State, of and shall have been approved by FDA is loss of FDA approval, within a in accordance with 88 900.21 and 900.22.

i) Electronic product means:

tion 534 of the Federal Food, Drug, and 1) Any manufactured or assembled Cosmetic Act. duct which, when in operation:

(m) Infrasonic, sonic (or audible) and i) Contains or acts as part of an elec

ultrasonic waves refer to energy transnic circuit and

mitted as an alteration (pressure, parii) Emits (or in the absence of effec

ticle displacement or density) in a e shielding or other controls would

property of an elastic medium (gas, liqit) electronic product radiation, or

uid or solid) that can be detected by an 2) Any manufactured or assembled

instrument or listener. ticle that is intended for use as a

(n) Manufacturer means any person mponent, part, or accessory of a

engaged in the business of manufacoduct described in paragraph (j)(1) of

turing, assembling, or importing elecis section and which, when in operion, emits (or in the absence of effec

tronic products. Te shielding or other controls would

(0) Model means any identifiable, nit) such radiation.

unique electronic product design, and (k) Electronic product radiation means:

refers to products having the same (1) Any ionizing or nonionizing elec

structural and electrical design characomagnetic or particulate radiation,

teristics and to which the manufac

turer has assigned a specific designa(2) Any sonic, infrasonic, or ultra

tion to differentiate between it and inic wave that is emitted from an other products produced by that manuectronic product as the result of the facturer. peration of an electronic circuit in (p) Model family means products hav

ing similar design and radiation char(1) Federal standard means a perform acteristics but different manufacturer nce standard issued pursuant to sec- model numbers.

ich product.