Environmental Engineering Reference
In-Depth Information
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A.sponsor.of.a.Class.I.or.Class.II.device,.who.is.otherwise.exempt.from.
submitting.a.510(k),.would.need.to.submit.a.510(k).because.the.presence.
or.amount.of.nanoscale.material.would.result.in.the.device.being.outside.
the.scope.of.the.limitations.of.exemption.described.in.the.general.provi-
sions.of.the.applicable.regulations.(
see
.21.C.F.R..§§.862.9-892.9).
A.sponsor.should.submit.a.new.510(k).for.a.modiication.to.a.previously.
cleared.device.that.incorporates.the.use.or.increased.use.of.nanoscale.
materials.
Institutional. Review. Boards,. investigators,. and. industry. should. seek.
input. from. the. FDA. on. signiicant. risk/nonsigniicant. risk. decisions.
regarding.investigational.devices.containing.nanoscale.materials.
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For.products.not.subject.to.pre-market.authorization:
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Issue. a. notice. in. the.
Federal Register
requesting. submission. of. data. and.
other. information. addressing. the. effects. on. product. safety. of. nanoscale.
materials.in.products.not.subject.to.pre-market.authorization.
Issue. guidance. or. amend. existing. guidance. to. describe. what. additional.
or.distinct.information.should.be.submitted.to.the.FDA.or.generated.with.
regard.to:
The.use.of.nanoscale.materials.in.food.ingredients.for.which.a.GRAS.
notiication. is. submitted. or. the. reduction. of. particle. size. into. the.
nanoscale. range. for. food. ingredients. for. which. an. earlier. notiication.
had.been.submitted.and.not.objected.to.by.the.FDA
The.use.of.nanoscale.materials.in.new.dietary.ingredients
Issue. guidance. recommending. manufacturers. consider. whether. and. how.
the.presence.of.nanoscale.materials.affects.the.manufacturing.process.
Issue.guidance.describing.safety.issues.that.manufacturers.should.consider.
to.ensure.that.cosmetics.made.with.nanoscale.materials.are.not.adulterated.
Issue.guidance.on.whether.a.dietary.ingredient.modiied.to.include.nanoscale.
materials.or.include.a.greater.proportion.of.nanoscale.materials.would.still.
qualify.as.a.dietary.ingredient.under.21.U.S.C..Section.321(ff)(1),.and.when.
the.reduction.in.size.into.the.nanoscale.range.of.an.“old”.dietary.ingredient.
might.trigger.the.notiication.process.required.for.a.new.dietary.ingredient.
on.the.basis.of.the.presence.or.amount.of.nanoscale.materials.
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issue: Permissible and Mandatory labeling
According. to. the. Task. Force,. because. current. science. does. not. support. a. inding.
that.classes.of.products.with.nanoscale.materials.necessarily.present.greater.safety.
concerns.than.classes.of.products.without.nanoscale.materials,.the.Task.Force.does.
not.believe.there.is.a.basis.for.saying.that,.as.a.general.matter,.a.product.containing.
nanoscale. materials. must. be. labeled. as. such.. Therefore. the. Task. Force. does. not.
recommend.that.the.FDA.require.such.labeling.at.this.time..Instead,.the.Task.Force.
recommends.that.the.FDA.address.on.a.case-by-case.basis.whether.labeling.must.or.
may.contain.information.on.the.use.of.nanoscale.materials.
