FDA Policy

To stay up to date on the latest news and guidance’s from the FDA visit CDRHNew – News and Updates.

For a list of who to contact at FDA regarding COVID-19 issues for medical devices visit Contacts for Medical Devices During the COVID-19 Pandemic.

AdvaMed provided FDA with a list of frequently asked questions related to the COVID-19 public health emergency. View the Agency’s responses.

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Clinical Trials

Given FDA’s recognition that the COVID-19 pandemic could impact the conduct of clinical trials of medical products, FDA issued a Final Guidance on March 18, 2020 to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity.

• *March 24, 2020 | AdvaMed Letter to FDA: Letter to Owen Faris RE Clinical Trials Flex Proposals
• March 18, 2020 | FDA Final Guidance: FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic

AdvaMed Staff Contact: Tara Federici

Device Shortage Reporting

• March 27, 2020 | President Trump signs (CARES Act) that includes the provision for mandatory device reporting during a public health emergency. The device reporting provision begins on page 223 (line 7 “Subpart C – Preventing Medical Device Shortages”).

AdvaMed Staff Contact: Janet Trunzo

Diagnostic Tests Policy

On March 16, 2020, the FDA issued guidance to provide a policy to help accelerate the availability of novel coronavirus (COVID-19) diagnostic tests developed by laboratories and commercial manufacturers during the public health emergency.

• March 16, 2020 | Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency; Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff

AdvaMed Staff Contact: Susan Van Meter

Domestic Surveillance

FDA temporarily postpones all domestic routine surveillance facility inspections

• March 18, 2020 | FDA Statement: Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections

AdvaMed Staff Contact: Janet Trunzo

Emergency Use Authorizations

Information regarding Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices may be found here. 

The video provides information on what an EUA is and how FDA utilizes this tool to help make important medical products available during the COVID-19 pandemic: Emergency Use Authorization (EUA) video

AdvaMed Staff Contact: Janet Trunzo