Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices
Posts published in “Guidance”
Ongoing Guidance development within MDCG Subgroups
CDRH Proposed Guidances for Fiscal Year 2020 (FY 2020)
Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling
Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labeling Considerations
9/13/2019 – Format for Traditional and Abbreviated 510(k)s: Guidance for Industry and FDA Staff 9/13/2019 – Refuse to Accept Policy for 510(k)s: Guidance for Industry and Food…
Safety and Performance Based Pathway
GUIDELINES on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or…
Acceptance Review for De Novo Classification Requests
Humanitarian Device Exemption (HDE) Program