Regulatory Review2026-05-082 min read

March Medical Device Review Data Released: Multiple Workstreams Advanced in Parallel

March medical device review data shows synchronized progress across registration review, acceptance, supplementary materials, expert consultation, quality system verification, innovation review, and priority approval.

March Review Data

March medical device review data has been released, showing that multiple workstreams advanced in parallel.

Category	Item	Count
Registration application matters	Applications transferred into technical review	1,560 items
Registration application matters	Projects transferred out after review completion	1,373 items
Registration application acceptance	Registration applications accepted	2,333 items
Registration application acceptance	Change filings	719 items
Registration application acceptance	Imported Class I device filings	230 items
Supplementary and correction materials	Supplementary material notices issued by the center	705 notices
Supplementary and correction materials	Correction materials received	684 submissions
Expert consultation meetings	Expert consultations initiated	33 items
Expert consultation meetings	Expert consultation meetings organized	14 meetings
Registration quality management system inspection	Registration QMS inspections initiated	358 items
Registration quality management system inspection	Inspection results received	246 items
Special review for innovative medical devices	Innovation applications accepted	51 items
Special review for innovative medical devices	Expert review meetings organized	42 meetings
Special review for innovative medical devices	Reviews completed	43 items
Priority approval medical device review	Priority approval applications accepted	6 items
Priority approval medical device review	Reviews completed	5 items

source: High Usability (our partner): www.high-usability.com

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