Get Ready For 100 New Fda Guidance Documents

Get Ready for 100 New FDA Guidance Documents

What Should New Medical Device Design Customer Should Know About Them?


Last month, we wrote a blog, Deciphering FDA Medical Device Design Guidance Documents, in which we focused on a specific and new guidance document, Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff.


Along with using it as an opportunity to provide an overview about human factors, it was also an opportunity to demonstrate what types of information and concepts are presented in an FDA guidance document.


The timing could not have been better! The other week, the FDA published Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2016, in which approximately 100 new guidance documents were proposed.


As we said in the last related blog, because getting FDA approval is a crucial step in commercializing a new medical device, it would be foolish to ignore any new guidances—if for any other reason, doing so can come at the peril of delaying a new medical product’s launch. Although guidance documents might be perceived merely as suggestions and recommendations, the reality is that they are highly qualified instructions that should inspire medical device development companies to more closely examine best practices that result in safer and more ef-fective medical devices.


Fortunately, not all of them apply directly or even indirectly to new medical devices—for instance, a guidance for advertising prescription drugs. However, there are many that do relate to new medical devices, which in-cludes the following and the categories in which they are contained.


• New Medical Device Advertising Guidances

• Internet/Social Media Advertising and Promotional Labeling of Prescription Drugs and Medical Devices – Use of Links to Third-Party Sites


• Manufacturer Communications Regarding Unapproved, Unlicensed, or Uncleared Uses of Approved, Li-censed, or Cleared Human Drugs, Biologics, Animal Drugs and Medical Devices


• Presenting Risk Information in Prescription Drugs and Medical Devices Promotion; Revised Draft


• New Medical Device Clinical Guidances

• Pediatric Oncology Product Development; Revised Draft


• New Medical Device Electronic Submissions Guidances

• NDA and BLA Content for Planning and Conduct of Bioresearch Monitoring Inspections (BIMO) for CDER Submissions


• Providing Regulatory Submissions in Electronic Format – Submission of Manufacturing Establishment In-formation


• New Medical Device Procedural Guidances

• DSCSA Implementation: Products Eligible for Grandfather Status


FDA, which closely follows matters pertaining to healthcare regulations, business and public policy, accurately commented that “for all manufacturers, this is a must read list and topics to keep track of.” However, the more our medical device design customers understands about the regulatory matters related to their products, the better we can be prepared to discuss them with you. Not only does this expedite the process “from concept to commercialization,” but it also helps eliminate risk when your new medical product is submitted to FDA clearances and later when it is in the market.


In coming weeks and months, we will discuss some of these guidances in more detail once they are published by the FDA!