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Important FDA regulatory news for ophthalmology product developers

Regulatory history was made on 9 August 2021 in a Federal Register notice (Docket No: FDA-2021-N-0843) announcing that in accordance with the Genus decision, FDA intends to regulate products that meet both drug and device definition as medical devices, except where the statute indicates that Congress intended a different classification. The first direct consequence of this case has resulted in FDA issuing a new FDA guidance for immediate implementation in the ophthalmology space. Specifically, for ophthalmology products to be used with eye cups, droppers, or other dispensing aids, the FDA intends to regulate these products as drug-led combination products (see https://www.fda.gov/media/157067/download).

Why Trust the Facet Life Sciences team with your ophthalmology product.

  • Facet team members have scientific training and extensive, recent ophthalmology experience
  • Facet works with trusted partners and key opinion leaders in ophthalmology
  • Indications recently supported: dry eye, glaucoma, meibomian gland dysfunction, wet AMD, and uveitis

Facet has worked on drugs, biologics, medical device, and combination ophthalmology products:

We have prepared nonclinical, CMC, and clinical development plans for a variety of ophthalmology candidates

We have successfully sheparded Type A, B (including EOP), and C meetings with FDA’s CDER, CBER, and CDRH.  We have also been involved in multi-center meetings.

We have provided strategic oversight, content development, and finalization of IND, NDA/BLA, and 510K applications

We have successfully secured orphan designation for products that target rare ocular diseases and conditions

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