Submissions and Approvals

ARTICLES

FDA Approves Reconfigured OTC Asthma Inhaler

FDA Commissioner Scott Gottlieb offered assurances about the agency’s approval of an OTC asthma inhaler that was previously pulled from the U.S. market in 2011. Read More

Profile: All Eyes on First Approved AI Diagnostic Tool

The doctor behind the first autonomous artificial intelligence-driven diagnostic system to win approval from the FDA is showing his work. Read More

FDA Approves Magnetic Lymph Node Biopsy Device

The FDA approved an innovative magnetic device for guiding lymph node biopsies in mastectomy patients that doesn’t require an injection of radioactive materials. Read More

FDA Approves First Artificial Iris

In its first approval of an artificial iris, the FDA approved HumanOptics’ CustomFlex, a surgically implanted device to treat adults and children whose iris is completely missing or damaged. Read More

FDA Clarifies How to Get Feedback Prior to Marketing Submissions

The FDA used a Q&A format to issue final guidance on an informal, non-binding process for sponsors to obtain preliminary feedback before submitting marketing applications. Read More

FDA Warns German Device Firm Over Lack of Procedures

A four-day FDA inspection of Curasan’s manufacturing facility in Frankfurt, Germany revealed a lack of manufacturing and adverse event reporting procedures. Read More

Regulatory Hurdles for Design Changes Stall BSI’s Market Comeback

Boston Scientific is facing regulatory hurdles with its proposed manufacturing process and design changes to bring its transcatheter aortic valve back to the U.S. and EU markets. Read More

Health Canada Clarifies Factors Used for Medical Device Classifications

Health Canada updated its classification guidance to give industry more clarity on the factors it uses to determine whether a product is a medical device or drug. Read More

CDRH Clarifies Acceptance and Refusal Policies for 510(k)s and PMAs

CDRH updated its guidances on policies used for making determinations on accepting or refusing 510(k) submissions and premarket approval applications. Read More

CDRH Proposes to Clarify all Appeal Decisions are ‘Significant’

The FDA issued a proposed rule that would clarify the CDRH decision appeal process and expand the scope of what would be considered a “significant decision.” Read More