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, …
Happy Birthday Laboratory Developed Tests (LDTs). Thirty years ago today, FDA announced that it had the authority to regulate you. Not yet understanding how important you’d become, you entered the regulatory world without a name – the Agency simply referred to you as “home brew” products. …
On July 19, 2022, CDRH announced to users of its Customer Collaborations Portal (CCP) that it is now accepting premarket submissions electronically. This came quickly after an announcement was made earlier in the summer that this functionality would soon be enabled for existing users of …
Last month, FDA announced two important steps towards accepting electronic 510(k) submissions. The first relates to the Customer Collaborations Portal (or CCP). As discussed in our prior post on the CCP (here), the CCP is currently a submission tracker providing details of completed and upcoming …
There is a lot to unpack in the 430 pages of FDASLA, which means that some provisions are falling a little under the radar. One of those provisions is an unusual one in which Congress directs FDA to issue final rules concerning Over-the-Counter hearing aids. …
CDRH appears to be taking another step towards returning to pre-pandemic life. On May 31, Drs. Shuren and Maisel announced that OHT7 (formerly OIR) will now be accepting all types of pre-submissions (see announcement here). As you’ll recall from our earlier post (here), OHT7 had …
As the User Fee Acts move through Congress, it has been clear that FDA is using them as a vehicle to legislatively overturn some big court losses over the last few years. As faithful readers of our blog know, FDA’s broad interpretations of its governing …
On June 3, FDA announced, via email to industry, that it plans to withdraw the guidance “Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices–Questions and Answers (Revised).” This guidance did two things: (1) automatically extended hold …
On June 14-15 in Washington, DC, the Food and Drug Law Institute (FDLI) will hold its first in-person Annual Conference since 2019. The conference brings together leading regulators and a wide range of stakeholders to discuss current issues and trends of importance to FDA-regulated industries. …
On April 19, FDA issued a safety communication regarding genetic non-invasive prenatal screening, commonly referred to as non-invasive prenatal tests or NIPT (here). NIPT are intended to screen for genetic abnormalities in a fetus. The tests are not intended to diagnose any genetic conditions – …
On March 22, FDA announced that it reached agreement with representatives from the medical device industry on proposed recommendations to Congress for the fifth reauthorization of the Medical Device User Fee Amendments (MDUFA V). MDUFA authorizes FDA to collect fees from certain medical device applicants …
One of the more complex areas of device regulation is the management of risks associated with malfunctions reported from the field. A critical task in this situation is for a firm to estimate the risk posed by the issue as accurately as possible. This estimation …
Legislation has been proposed in Congress that would require FDA to regulate all contrast agents as drugs even though two courts determined that doing so clearly contradicts the plain language of the Federal Food Drug and Cosmetic Act (“FDC Act”). Unless amended, the proposed legislation …
It’s not often that FDA issues an “Immediately in Effect Guidance,” but it’s not often that a case like Genus v. FDA comes along and upends twenty years of FDA practice. Almost a year after the D.C. Circuit held that products that simultaneously meet both …
In late December, as cases of Omicron were soaring, CDRH issued two draft guidance documents to prepare for the end of the public health emergency. The pair of draft guidances laid out the transition for devices that are being marketed under an EUA and devices …
