The US agency issued a new draft guidance to require medical device and diagnostics manufacturers and distributors to report supply chain issues in the event of a public health emergency.
The US Food and Drug Administration wants to make permanent a previous guidance that requires medtech manufacturers and distributors to notify the agency of a product shortage during a public health emergency. The previous November 2020 guidance expires with the COVID-19 pandemic health emergency, but the agency wants to make sure it stays in place for future emergencies.
According to the draft guidance published on 10 January, device and diagnostics makers would need to notify the FDA...
The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.
FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.
The US FDA's new draft guidance details the responsibilities of new owners of 510(k) clearances, including making timely updates device listings in FURLS and GUDID to maintain accurate information for safety alerts and recalls. Comments on the draft are accepted until 4 August.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.
FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.
The US FDA's new draft guidance details the responsibilities of new owners of 510(k) clearances, including making timely updates device listings in FURLS and GUDID to maintain accurate information for safety alerts and recalls. Comments on the draft are accepted until 4 August.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.
