Medmarc Blog (blog.medmarc.com)
Clinical Trials (2)
FDA Informed Consent Guidance Subject to Near-Term Changes
On Aug. 15, 2023, the FDA released a guidance for informed consent which states that a medical device clinical trial may not proceed until the sponsor addresses the agency’s concerns regarding the...
FDA Proposes Two New Rules to Eliminate Contradictions with the HHS’ Common Rule
The US Food and Drug Administration (FDA) has long held rules governing clinical investigations and studies that support research and marketing applications. These regulations are stricter...
FDA Strives to Harmonize 21 CFR Part 820 with ISO 13485:2016
The Food and Drug Administration (FDA) has continued to move towards harmonizing U.S. regulations with international standards for the regulation of medical devices. On February 23, 2022, FDA...
FDA Releases New Draft Guidance for the Use of Digital Health Technologies in Clinical Trials
In December 2021, FDA issued draft guidance document titled “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.” The guidance discusses the proper use of...
FDA Releases Two Draft Guidance Documents to Advise Manufacturers on Post COVID-19 Protocol
During the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) felt pressured to expeditiously authorize new medical devices that could protect the public. Medical equipment such as...