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Industry Praises PMA-Acceptance Draft Guidance, But Offers A Few Suggestions

Companies are generally happy with FDA’s July 31 draft guidance describing a 15-day "acceptance review" that FDA staff will perform to quickly check that a PMA submission meets minimum requirements.

The device trade association AdvaMed sees "positive steps" in FDA's proposed new procedures for accepting and filing pre-market approval applications; manufacturing firm Cook is "very pleased;" and Johnson & Johnson says the draft "accurately reflects the spirit" of agreements reached by industry and FDA earlier this year.

They were among 11 entities that submitted comments on a draft guidance describing a 15-day "acceptance review" that FDA staff will perform to quickly check that a PMA submission is...

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