“We still have a problem with COVID. We’re still doing a lot of work on it. But the pandemic is over. If you notice, no one is wearing masks. Everybody seems to be in pretty good shape. And so I think it’s changing.” President Biden made …
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Medical Devices
- Planning for the End of the COVID-19 Public Health EmergencyOctober 14th, 2022
- The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures ActOctober 10th, 2022
On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. The CDS Guidance interprets the “medical software” carve-out of the 21st Century Cures Act (2016) as it pertains …
- Sponsors May Now Request Access to the CCP for Filing of Device Premarket Submissions ElectronicallyOctober 6th, 2022
It is with great excitement that we share CDRH’s announcement that now anyone may submit premarket submissions directly to the Center through the Customer Collaboration Portal (CCP). We heard from a number of readers after our prior post (here) asking how they could get access …
- Electronic Submission Template for Medical Device 510(k) SubmissionsOctober 6th, 2022
Nearly one year after FDA published a draft guidance on its Electronic Submission Template for Medical Device Submissions (see our blog post here), the Agency is back to formally introduce the widespread implementation of the electronic Submission Template And Resource (eSTAR) electronic submission template for …
- Allegations of Regulatory Misconduct Against Medical Device Manufacturers: Greater Transparency NeededOctober 4th, 2022
Allegations of regulatory misconduct are claims that a medical device manufacturer or marketers of medical devices operate in such a way that violates the law. Allegations may include failure to register and list a medical device, promotion of a device outside the scope of its …
- Third time’s a charm? FDA Issues Final Guidance on Regulation of Clinical Decision Support SoftwareOctober 2nd, 2022
On September 28, 2022, FDA published its long-awaited final guidance document entitled “Clinical Decision Support Software,” which interprets the medical software provisions of the 21st Century Cures Act (Cures Act). The final guidance was preceded by two iterations of draft guidance—one in 2017 and one in …
- FDA Safety Communications: A Potential Provider PitfallSeptember 28th, 2022
The New Jersey Supreme Court, in its August 25, 2022 opinion in Mirian Rivera v. Valley Hospital, Inc., 2022 N.J. LEXIS 679 (NJ Aug. 25, 2022), https://www.njcourts.gov/attorneys/assets/opinions/supreme/a_25_26_27_21.pdf?c=lmL, considered whether a provider’s use of a medical device that is the subject of an FDA safety communication …
- How to get the Inside Track for Your Monkeypox EUASeptember 27th, 2022
Similar to what was done with COVID-19, the National Institute for Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative has established a Monkeypox Independent Test Assessment Program (ITAP) and it currently accepting new proposals on a rolling basis to address the outbreak. The program began …
- (Slightly More) Options for cGMP for Combination Products: FDA Describes Alternative or Streamlined Mechanisms for ComplianceSeptember 26th, 2022
FDA recently published Alternative or Streamlined Mechanisms for Complying with the Current Good Manufacturing Practice Requirements for Combination Products; List under the 21st Century Cures Act in the Federal Register (FR Notice). By way of background, 21 C.F.R. § 4.3 requires generally that manufacturing of a …
- FDA Redux? CDRH Policy and EUA Templates for Monkeypox Tests Following Public Health Emergency Declaration Mirror FDA’s COVID-19 ApproachSeptember 21st, 2022
On August 9, 2022, the Secretary of the Department of Health and Human Services (HHS) declared the outbreak of monkeypox virus a public health emergency (see announcement here). On September 7, 2022, the Secretary of HHS declared that “circumstances exist justifying the authorization of emergency …
- A Review of CDRH’s Electronic Submission ProcessSeptember 14th, 2022
As promised in our posts from earlier this summer (here and here), we are back to report on our assessment of CDRH’s electronic submission process through its Customer Collaboration Portal (CCP). In short, the process is FANTASTIC! Say goodbye to your thumb drives and CDs …
- Choice of Secondary Predicate versus Reference Devices in a 510(k) SubmissionSeptember 13th, 2022
It’s been almost 11 years since FDA first clarified use of multiple predicate devices and introduced the concept of Reference Devices in the draft guidance titled The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], which we blogged about here. The final guidance with …
- Papa Can You Hear Me? Now You Can Thanks to OTC Hearing AidsAugust 18th, 2022
After 5 long years, FDA has finally adopted the long-awaited OTC hearing aid rules. While the Proposed Rule was a year and a half overdue, FDA impressively turned out the Final Rule about 7 months after the close of comments on the Proposed Rule, which …
- FDA Inspections Back Up To Speed (Except Those Now Deemed Unnecessary)August 16th, 2022
Those of us who work frequently on FDA inspections of drug and medical device manufacturing facilities have noticed an uptick in regular inspections after a dramatic falloff during the first two years of COVID. That impression was corroborated this week at the GMP by the …
- ACI’s FDA Boot Camp – September 14-15, 2022 (Virtual)August 5th, 2022
The American Conference Institute is hosting their 39th FDA Boot Camp from September 14-15, 2022. The conference will be held virtually. Gain insight and training in core regulatory concepts for life sciences attorneys, business executives, and policy analysts. The approval process, pre-approval concerns, product labeling, clinical trials, …