Cybersecurity and FDA Compliance

FDA Ramping Up Cybersecurity Compliance

By Charles Parker, II

On October 1, 2023 the FDA enacted the Cybersecurity Refuse to Accept (RTA) policy. In essence, any  medical device which does not meet its pre- and post-market cybersecurity guidance can be turned away. In June 2023, the FDA published its final set of guidance regarding the Electronic Submission Template and Resource (eSTAR). This new statute is wide ranging, increasing the FDA’s authority.

If the company were not to comply with the new regulation there are distinct consequences which may include delays in market entry, reputational damage, and enforcement actions. This continues to emphasize the importance of cybersecurity.

About the Author-

Charles Parker II has been working in the info sec field for over a decade, in the banking, medical, automotive, and staffing industries. Charles has matriculated and attained the MBA, MSA, JD, LLM, and is in the final stage of the PhD in Information Assurance and Security (ABD) from Capella University. Mr. Parker’s areas of interest include cryptography, AV, and SCADA.