Food and Drug Administration

FDA

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July 2026

Notice · Food and Drug Administration · Jul 22

Reference 10 - FDA, ''Technical Considerations for Additive Manufactured Medical Devices" (December 2017)

Notice · Food and Drug Administration · Jul 22

Reference 9 - Nano-silver/carbon nanotube composite coatings on airway stents (Sci Rep 2025; open access)

Notice · Food and Drug Administration · Jul 22

Reference 8 - Kostov KG, et al. Plasma Surface Modification of the Inner Wall of Montgomery's Tracheal Implant (Polymers 2024; open access)

Notice · Food and Drug Administration · Jul 22

Reference 7 - FDA 51 0(k) Summary: Patient-Specific Airway Stent (K 182743)

Notice · Food and Drug Administration · Jul 22

Reference 6 - FDA Custom Device Exemption Guidance (September 2014)

Notice · Food and Drug Administration · Jul 22

Citizen Petition from Cheol Ho Song

Notice · Food and Drug Administration · Jul 22

Completeness Assessment Correspondence

Notice · Food and Drug Administration · Jul 22

Notice · Food and Drug Administration · Jul 22

Notice · Food and Drug Administration · Jul 22

Memorandum re Drug Establishment Registration (Proposed Rule)

Notice · Food and Drug Administration · Jul 22

Final Response Letter from FDA CDER to Hyman, Phelps & McNamara, P.C.

Notice · Food and Drug Administration · Jul 22

Final Response Letter from FDA CDER to APDM Pharmaceuticals Private Limited

Notice · Food and Drug Administration · Jul 22

TAB C-2023-173-Drug Establishment-Proposed Rule-Final

Notice · Food and Drug Administration · Jul 22

TAB C-2023-173-Drug Establishment-PRIA-Final

Notice · Food and Drug Administration · Jul 22

TAB B-2023-173-Drug Establishment-Proposed Rule-TRACK CHANGE FROM ORIGINAL TO FINAL

Notice · Food and Drug Administration · Jul 22

TAB B-2023-173-Drug Establishment-PRIA-TRACK CHANGE FROM ORIGINAL TO FINAL

Notice · Food and Drug Administration · Jul 22

TAB A-2023-173-Drug Establishment-Proposed Rule-Original

Notice · Food and Drug Administration · Jul 22

TAB A-2023-173-Drug Establishment-PRIA-Original

Notice · Food and Drug Administration · Jul 22

Response Letter from FDA CDER to American Cleaning Institute

Notice · Food and Drug Administration · Jul 22

Acknowledgment Letter from FDA DMB to Bryan Smith

Upcoming deadlines

Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities—Questions and Answers; Revised Draft Guidance for Industry

Comment closes · Aug 4

Determination of Regulatory Review Period for Purposes of Patent Extension; BEQVEZ

Comment closes · Aug 6

Determination of Regulatory Review Period for Purposes of Patent Extension; COBENFY

Comment closes · Aug 6

Determination of Regulatory Review Period for Purposes of Patent Extension; COBENFY

Comment closes · Aug 6

Determination of Regulatory Review Period for Purposes of Patent Extension; COBENFY

Comment closes · Aug 6

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