On November 29, 2017, CDRH issued two draft guidances regarding CLIA Waiver requests: “Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1998 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices” (CLIA Waiver Guidance) and “Recommendations for Dual 510(k) and CLIA Waiver …
The field of digital health is relatively new and is growing fast. Because many uses of software for health‑related purposes are within the statutory definition of a medical device, the Food and Drug Administration (FDA) is a major player in determining how digital health will …
On February 19, 2015, FDA granted de novo authorization to 23andMe for genetic tests for autosomal recessive traits that are offered directly to consumers (DEN140044). Nearly three years later, FDA has proposed a pathway that opens this avenue further. In a statement on November 6 …
On October 30, CDRH issued the Final Guidance “De Novo Classification Process (Evaluation of Automatic Class III Designation)” (the “De Novo Guidance”). This is a final version of the 2014 draft by the same name (see our earlier blog post here). On the same day, …
The recently-enacted Food and Drug Administration Reauthorization Act (“FDARA”) includes the Medical Device User Fee Amendments of 2017 (“MDUFA IV”) (see our summary here). This new law affects multiple aspects of the device review process. MDUFA IV supplements FDA’s funding of device regulation, with the goal …
On October 30, CDRH finalized the guidance entitled, “Manufacturers Sharing Patient-Specific Information From Medical Devices With Patients Upon Request”. This is the final version of the guidance, “Dissemination of Patient-Specific Information from Devices by Device Manufacturers” issued in June 2016 (see our blog post on …
On October 25, 2017, FDA issued a final guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device. This guidance is a final version of the draft issued in 2016 (see our post on the 2016 draft here). Despite receiving a …
Digital health technologies are moving forward toward rapid adoption in the United States. Yet, software developers are often apprehensive about the often long and detailed process of FDA’s premarket review. FDA’s new Digital Health Software Precertification (Precert) Program (“Precert Program”), announced in August 2017 (see …
On October 31st, FDA made its long anticipated announcement recognizing the first European drug regulatory authorities capable of conducting inspections of manufacturing facilities that meet FDA requirements. The eight countries that were announced are: Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom. The …
The 21st Century Cures Act (Cures), signed into law in December 2016, established a program to provide priority review and management attention for breakthrough devices. We discussed the new section of the law in our earlier post on Cures (here). The law required FDA to …
Our April 16th blog post regarding 510(k) exemptions (here) garnered a lot of comments from our readers. So we thought it was worth a second post. As you will recall, the .9 limitation says that a device of the generic type in a 510(k)‑exempt classification regulation …
Getting an early jump on winter, between September 29 and October 2, CDRH issued a blizzard of new guidance documents. All eleven of these guidances were issued based on commitments from MDUFA IV. These guidances consist of: four guidances regarding user fees for each type of …
Sponsors commonly receive a request for additional information (AI) during Food and Drug Administration (FDA) review of a 510(k) submission, de novo classification request, or premarket approval application. In some cases, a sponsor may conclude that one or more AI requests calls for information that …
In July of last year, FDA released a draft guidance on evaluation and reporting of age-, race-, and ethnicity-specific data in medical device clinical studies (see our post on the draft guidance here). On September 12, 2017, FDA released the final version of this guidance. The …
On September 26, 2017, FDA combined and finalized two Draft Guidance documents first issued in 2011 that set forth the Agency’s approach to classifying products as “drugs” or “devices” under the FDC Act § 201. In doing so, FDA trimmed significant portions of both Draft …
